Trial Outcomes & Findings for Study in Subjects Undergoing Complete Abdominoplasty (NCT NCT03789318)
NCT ID: NCT03789318
Last Updated: 2024-03-19
Results Overview
Numeric Rating Scale (NRS) of pain intensity from 0-10 where 0 is no pain and 10 is the worst pain imaginable at 96 hours
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
54 participants
Primary outcome timeframe
96 hours
Results posted on
2024-03-19
Participant Flow
Participant milestones
| Measure |
CA-008 5 mg (0.05 mg/mL) Cohort 1
Cohort 1 (CA-008 5 mg): the surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).
CA-008 5 mg: 5 mg CA-008 reconstituted in saline.
Bupivacaine Hydrochloride: 0.25% administered pre-surgery
Hydromorphone: 0.02 mg/kg IV administered intraoperatively
Fentanyl: 100 mcg IV administered intraoperatively
Acetaminophen: 1000 mg IV administered intraoperatively
Oxycodone: 5-10 mg PO administered post-surgery
|
Placebo for Cohort 1
Cohort 1: the surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).
Placebo: Each cohort will use placebo reconstituted in saline.
Bupivacaine Hydrochloride: 0.25% administered pre-surgery
Hydromorphone: 0.02 mg/kg IV administered intraoperatively
Fentanyl: 100 mcg IV administered intraoperatively
Acetaminophen: 1000 mg IV administered intraoperatively
Oxycodone: 5-10 mg PO administered post-surgery
|
CA-008 10 mg (0.1 mg/mL) Cohort 2
Cohort 2 (CA-008 10 mg): the surgery is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).
Bupivacaine Hydrochloride: 0.25% administered pre-surgery
Hydromorphone: 0.02 mg/kg IV administered intraoperatively
Fentanyl: 100 mcg IV administered intraoperatively
Acetaminophen: 1000 mg IV administered intraoperatively
Oxycodone: 5-10 mg PO administered post-surgery
CA-008 10 mg: 10 mg CA-008 reconstituted in saline.
|
CA-008 15 mg (0.15 mg/mL) Cohort 3
Cohort 3 (CA-008 15 mg): the surgery is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).
Bupivacaine Hydrochloride: 0.25% administered pre-surgery
Hydromorphone: 0.02 mg/kg IV administered intraoperatively
Fentanyl: 100 mcg IV administered intraoperatively
Acetaminophen: 1000 mg IV administered intraoperatively
Oxycodone: 5-10 mg PO administered post-surgery
CA-008 15 mg: 15 mg CA-008 reconstituted in saline.
|
Placebo for Cohorts 2 and 3
Cohorts 2 \& 3: the surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).
Placebo: Each cohort will use placebo reconstituted in saline.
Bupivacaine Hydrochloride: 0.25% administered pre-surgery
Hydromorphone: 0.02 mg/kg IV administered intraoperatively
Fentanyl: 100 mcg IV administered intraoperatively
Acetaminophen: 1000 mg IV administered intraoperatively
Oxycodone: 5-10 mg PO administered post-surgery
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
12
|
12
|
12
|
|
Overall Study
COMPLETED
|
9
|
9
|
9
|
11
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
3
|
1
|
0
|
Reasons for withdrawal
| Measure |
CA-008 5 mg (0.05 mg/mL) Cohort 1
Cohort 1 (CA-008 5 mg): the surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).
CA-008 5 mg: 5 mg CA-008 reconstituted in saline.
Bupivacaine Hydrochloride: 0.25% administered pre-surgery
Hydromorphone: 0.02 mg/kg IV administered intraoperatively
Fentanyl: 100 mcg IV administered intraoperatively
Acetaminophen: 1000 mg IV administered intraoperatively
Oxycodone: 5-10 mg PO administered post-surgery
|
Placebo for Cohort 1
Cohort 1: the surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).
Placebo: Each cohort will use placebo reconstituted in saline.
Bupivacaine Hydrochloride: 0.25% administered pre-surgery
Hydromorphone: 0.02 mg/kg IV administered intraoperatively
Fentanyl: 100 mcg IV administered intraoperatively
Acetaminophen: 1000 mg IV administered intraoperatively
Oxycodone: 5-10 mg PO administered post-surgery
|
CA-008 10 mg (0.1 mg/mL) Cohort 2
Cohort 2 (CA-008 10 mg): the surgery is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).
Bupivacaine Hydrochloride: 0.25% administered pre-surgery
Hydromorphone: 0.02 mg/kg IV administered intraoperatively
Fentanyl: 100 mcg IV administered intraoperatively
Acetaminophen: 1000 mg IV administered intraoperatively
Oxycodone: 5-10 mg PO administered post-surgery
CA-008 10 mg: 10 mg CA-008 reconstituted in saline.
|
CA-008 15 mg (0.15 mg/mL) Cohort 3
Cohort 3 (CA-008 15 mg): the surgery is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).
Bupivacaine Hydrochloride: 0.25% administered pre-surgery
Hydromorphone: 0.02 mg/kg IV administered intraoperatively
Fentanyl: 100 mcg IV administered intraoperatively
Acetaminophen: 1000 mg IV administered intraoperatively
Oxycodone: 5-10 mg PO administered post-surgery
CA-008 15 mg: 15 mg CA-008 reconstituted in saline.
|
Placebo for Cohorts 2 and 3
Cohorts 2 \& 3: the surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).
Placebo: Each cohort will use placebo reconstituted in saline.
Bupivacaine Hydrochloride: 0.25% administered pre-surgery
Hydromorphone: 0.02 mg/kg IV administered intraoperatively
Fentanyl: 100 mcg IV administered intraoperatively
Acetaminophen: 1000 mg IV administered intraoperatively
Oxycodone: 5-10 mg PO administered post-surgery
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Study in Subjects Undergoing Complete Abdominoplasty
Baseline characteristics by cohort
| Measure |
Placebo for Cohort 1
n=9 Participants
Cohort 1:
Placebo comparator is identical in appearance to the investigational product, containing the same excipients as the active.
The surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).
Placebo: Each cohort will use placebo reconstituted in saline.
Bupivacaine Hydrochloride: 0.25% administered pre-surgery
Hydromorphone: 0.02 mg/kg IV administered intraoperatively
Fentanyl: 100 mcg IV administered intraoperatively
Acetaminophen: 1000 mg IV administered intraoperatively
Oxycodone: 5-10 mg PO administered post-surgery
|
CA-008 10 mg (0.1 mg/mL)
n=12 Participants
Cohort 2 (CA-008 10 mg): the surgery is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).
Bupivacaine Hydrochloride: 0.25% administered pre-surgery
Hydromorphone: 0.02 mg/kg IV administered intraoperatively
Fentanyl: 100 mcg IV administered intraoperatively
Acetaminophen: 1000 mg IV administered intraoperatively
Oxycodone: 5-10 mg PO administered post-surgery
CA-008 10 mg: 10 mg CA-008
|
CA-008 15 mg (0.15 mg/mL)
n=12 Participants
Cohort 3 (CA-008 15 mg): the surgery is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).
Bupivacaine Hydrochloride: 0.25% administered pre-surgery
Hydromorphone: 0.02 mg/kg IV administered intraoperatively
Fentanyl: 100 mcg IV administered intraoperatively
Acetaminophen: 1000 mg IV administered intraoperatively
Oxycodone: 5-10 mg PO administered post-surgery
CA-008 15 mg: 15 mg CA-008
|
Placebo for Cohorts 2 and 3
n=12 Participants
Cohorts 2 \& 3:
Placebo comparator in each cohort is identical in appearance to the investigational product, containing the same excipients as the active.
The surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).
Placebo: Each cohort will use placebo reconstituted in saline.
Bupivacaine Hydrochloride: 0.25% administered pre-surgery
Hydromorphone: 0.02 mg/kg IV administered intraoperatively
Fentanyl: 100 mcg IV administered intraoperatively
Acetaminophen: 1000 mg IV administered intraoperatively
Oxycodone: 5-10 mg PO administered post-surgery
|
Total
n=54 Participants
Total of all reporting groups
|
CA-008 5 mg (0.05 mg/mL) Cohort 1
n=9 Participants
Cohort 1 (CA-008 5 mg): the surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).
CA-008 5 mg: 5 mg CA-008
Bupivacaine Hydrochloride: 0.25% administered pre-surgery
Hydromorphone: 0.02 mg/kg IV administered intraoperatively
Fentanyl: 100 mcg IV administered intraoperatively
Acetaminophen: 1000 mg IV administered intraoperatively
Oxycodone: 5-10 mg PO administered post-surgery
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
38.2 years
STANDARD_DEVIATION 7.17 • n=107 Participants
|
43.3 years
STANDARD_DEVIATION 10.27 • n=206 Participants
|
43.3 years
STANDARD_DEVIATION 6.74 • n=7 Participants
|
38.3 years
STANDARD_DEVIATION 8.76 • n=31 Participants
|
40.4 years
STANDARD_DEVIATION 8.93 • n=30 Participants
|
37.8 years
STANDARD_DEVIATION 10.95 • n=99 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=31 Participants
|
54 Participants
n=30 Participants
|
9 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
25 Participants
n=30 Participants
|
5 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
29 Participants
n=30 Participants
|
4 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
17 Participants
n=30 Participants
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
33 Participants
n=30 Participants
|
7 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
9 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=31 Participants
|
54 Participants
n=30 Participants
|
9 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 96 hoursPopulation: Safety population
Numeric Rating Scale (NRS) of pain intensity from 0-10 where 0 is no pain and 10 is the worst pain imaginable at 96 hours
Outcome measures
| Measure |
CA-008 5 mg (0.05 mg/mL) Cohort 1
n=9 Participants
Cohort 1 (CA-008 5 mg): the surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).
CA-008 5 mg: 5 mg CA-008 reconstituted in saline.
Bupivacaine Hydrochloride: 0.25% administered pre-surgery
Hydromorphone: 0.02 mg/kg IV administered intraoperatively
Fentanyl: 100 mcg IV administered intraoperatively
Acetaminophen: 1000 mg IV administered intraoperatively
Oxycodone: 5-10 mg PO administered post-surgery
|
Placebo for Cohort 1
n=9 Participants
Cohort 1:
Placebo comparator is identical in appearance to the investigational product, containing the same excipients as the active comparator.
The surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).
Placebo: Each cohort will use placebo reconstituted in saline.
Bupivacaine Hydrochloride: 0.25% administered pre-surgery
Hydromorphone: 0.02 mg/kg IV administered intraoperatively
Fentanyl: 100 mcg IV administered intraoperatively
Acetaminophen: 1000 mg IV administered intraoperatively
Oxycodone: 5-10 mg PO administered post-surgery
|
CA-008 10 mg (0.1 mg/mL)
n=12 Participants
Cohort 2 (CA-008 10 mg): the surgery is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).
Bupivacaine Hydrochloride: 0.25% administered pre-surgery
Hydromorphone: 0.02 mg/kg IV administered intraoperatively
Fentanyl: 100 mcg IV administered intraoperatively
Acetaminophen: 1000 mg IV administered intraoperatively
Oxycodone: 5-10 mg PO administered post-surgery
CA-008 10 mg: 10 mg CA-008 reconstituted in saline.
|
CA-008 15 mg (0.15 mg/mL)
n=12 Participants
Cohort 3 (CA-008 15 mg): the surgery is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).
Bupivacaine Hydrochloride: 0.25% administered pre-surgery
Hydromorphone: 0.02 mg/kg IV administered intraoperatively
Fentanyl: 100 mcg IV administered intraoperatively
Acetaminophen: 1000 mg IV administered intraoperatively
Oxycodone: 5-10 mg PO administered post-surgery
CA-008 15 mg: 15 mg CA-008 reconstituted in saline.
|
Placebo for Cohorts 2 and 3
n=12 Participants
Cohorts 2 \& 3:
Placebo comparator in each cohort is identical in appearance to the investigational product, containing the same excipients as the active comparator.
The surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).
Placebo: Each cohort will use placebo reconstituted in saline.
Bupivacaine Hydrochloride: 0.25% administered pre-surgery
Hydromorphone: 0.02 mg/kg IV administered intraoperatively
Fentanyl: 100 mcg IV administered intraoperatively
Acetaminophen: 1000 mg IV administered intraoperatively
Oxycodone: 5-10 mg PO administered post-surgery
|
|---|---|---|---|---|---|
|
Pain Intensity Scores at 96 Hours at Rest Using Numerical Rating Scale (NRS)
|
2.8 score on a scale
Standard Deviation 2.59
|
2.0 score on a scale
Standard Deviation 2.12
|
3.0 score on a scale
Standard Deviation 2.22
|
2.8 score on a scale
Standard Deviation 3.10
|
1.8 score on a scale
Standard Deviation 1.96
|
SECONDARY outcome
Timeframe: 0 to 96 hoursPopulation: Safety population
Pain intensity scores (using a Numeric Rating Scale of pain intensity from 0-10 where 0 is no pain and 10 is the worst pain imaginable) from 0 to T96 hours
Outcome measures
| Measure |
CA-008 5 mg (0.05 mg/mL) Cohort 1
n=9 Participants
Cohort 1 (CA-008 5 mg): the surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).
CA-008 5 mg: 5 mg CA-008 reconstituted in saline.
Bupivacaine Hydrochloride: 0.25% administered pre-surgery
Hydromorphone: 0.02 mg/kg IV administered intraoperatively
Fentanyl: 100 mcg IV administered intraoperatively
Acetaminophen: 1000 mg IV administered intraoperatively
Oxycodone: 5-10 mg PO administered post-surgery
|
Placebo for Cohort 1
n=9 Participants
Cohort 1:
Placebo comparator is identical in appearance to the investigational product, containing the same excipients as the active comparator.
The surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).
Placebo: Each cohort will use placebo reconstituted in saline.
Bupivacaine Hydrochloride: 0.25% administered pre-surgery
Hydromorphone: 0.02 mg/kg IV administered intraoperatively
Fentanyl: 100 mcg IV administered intraoperatively
Acetaminophen: 1000 mg IV administered intraoperatively
Oxycodone: 5-10 mg PO administered post-surgery
|
CA-008 10 mg (0.1 mg/mL)
n=12 Participants
Cohort 2 (CA-008 10 mg): the surgery is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).
Bupivacaine Hydrochloride: 0.25% administered pre-surgery
Hydromorphone: 0.02 mg/kg IV administered intraoperatively
Fentanyl: 100 mcg IV administered intraoperatively
Acetaminophen: 1000 mg IV administered intraoperatively
Oxycodone: 5-10 mg PO administered post-surgery
CA-008 10 mg: 10 mg CA-008 reconstituted in saline.
|
CA-008 15 mg (0.15 mg/mL)
n=12 Participants
Cohort 3 (CA-008 15 mg): the surgery is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).
Bupivacaine Hydrochloride: 0.25% administered pre-surgery
Hydromorphone: 0.02 mg/kg IV administered intraoperatively
Fentanyl: 100 mcg IV administered intraoperatively
Acetaminophen: 1000 mg IV administered intraoperatively
Oxycodone: 5-10 mg PO administered post-surgery
CA-008 15 mg: 15 mg CA-008 reconstituted in saline.
|
Placebo for Cohorts 2 and 3
n=12 Participants
Cohorts 2 \& 3:
Placebo comparator in each cohort is identical in appearance to the investigational product, containing the same excipients as the active comparator.
The surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).
Placebo: Each cohort will use placebo reconstituted in saline.
Bupivacaine Hydrochloride: 0.25% administered pre-surgery
Hydromorphone: 0.02 mg/kg IV administered intraoperatively
Fentanyl: 100 mcg IV administered intraoperatively
Acetaminophen: 1000 mg IV administered intraoperatively
Oxycodone: 5-10 mg PO administered post-surgery
|
|---|---|---|---|---|---|
|
Weighted Sum of Pain Intensity (SPI) Assessments = AUC of NRS Scores
|
392.98 score on a scale*hours
Standard Deviation 138.191
|
392.67 score on a scale*hours
Standard Deviation 163.025
|
384.94 score on a scale*hours
Standard Deviation 136.551
|
406.88 score on a scale*hours
Standard Deviation 220.821
|
356.23 score on a scale*hours
Standard Deviation 175.969
|
SECONDARY outcome
Timeframe: From Surgery to Day 29Population: Safety population
Time to the last use of opioid
Outcome measures
| Measure |
CA-008 5 mg (0.05 mg/mL) Cohort 1
n=9 Participants
Cohort 1 (CA-008 5 mg): the surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).
CA-008 5 mg: 5 mg CA-008 reconstituted in saline.
Bupivacaine Hydrochloride: 0.25% administered pre-surgery
Hydromorphone: 0.02 mg/kg IV administered intraoperatively
Fentanyl: 100 mcg IV administered intraoperatively
Acetaminophen: 1000 mg IV administered intraoperatively
Oxycodone: 5-10 mg PO administered post-surgery
|
Placebo for Cohort 1
n=9 Participants
Cohort 1:
Placebo comparator is identical in appearance to the investigational product, containing the same excipients as the active comparator.
The surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).
Placebo: Each cohort will use placebo reconstituted in saline.
Bupivacaine Hydrochloride: 0.25% administered pre-surgery
Hydromorphone: 0.02 mg/kg IV administered intraoperatively
Fentanyl: 100 mcg IV administered intraoperatively
Acetaminophen: 1000 mg IV administered intraoperatively
Oxycodone: 5-10 mg PO administered post-surgery
|
CA-008 10 mg (0.1 mg/mL)
n=12 Participants
Cohort 2 (CA-008 10 mg): the surgery is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).
Bupivacaine Hydrochloride: 0.25% administered pre-surgery
Hydromorphone: 0.02 mg/kg IV administered intraoperatively
Fentanyl: 100 mcg IV administered intraoperatively
Acetaminophen: 1000 mg IV administered intraoperatively
Oxycodone: 5-10 mg PO administered post-surgery
CA-008 10 mg: 10 mg CA-008 reconstituted in saline.
|
CA-008 15 mg (0.15 mg/mL)
n=12 Participants
Cohort 3 (CA-008 15 mg): the surgery is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).
Bupivacaine Hydrochloride: 0.25% administered pre-surgery
Hydromorphone: 0.02 mg/kg IV administered intraoperatively
Fentanyl: 100 mcg IV administered intraoperatively
Acetaminophen: 1000 mg IV administered intraoperatively
Oxycodone: 5-10 mg PO administered post-surgery
CA-008 15 mg: 15 mg CA-008 reconstituted in saline.
|
Placebo for Cohorts 2 and 3
n=12 Participants
Cohorts 2 \& 3:
Placebo comparator in each cohort is identical in appearance to the investigational product, containing the same excipients as the active comparator.
The surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).
Placebo: Each cohort will use placebo reconstituted in saline.
Bupivacaine Hydrochloride: 0.25% administered pre-surgery
Hydromorphone: 0.02 mg/kg IV administered intraoperatively
Fentanyl: 100 mcg IV administered intraoperatively
Acetaminophen: 1000 mg IV administered intraoperatively
Oxycodone: 5-10 mg PO administered post-surgery
|
|---|---|---|---|---|---|
|
Time to Opioid Cessation or Freedom
|
56.37 hours
Interval 1.25 to 216.65
|
55.42 hours
Interval 1.08 to 156.2
|
83.89 hours
Interval 0.95 to 323.22
|
59.55 hours
Interval 1.13 to 362.63
|
42.26 hours
Interval 1.02 to 238.57
|
SECONDARY outcome
Timeframe: 24 to 96 hoursPopulation: Safety population
Percent of subjects who were opioid free at 24-96 hours
Outcome measures
| Measure |
CA-008 5 mg (0.05 mg/mL) Cohort 1
n=9 Participants
Cohort 1 (CA-008 5 mg): the surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).
CA-008 5 mg: 5 mg CA-008 reconstituted in saline.
Bupivacaine Hydrochloride: 0.25% administered pre-surgery
Hydromorphone: 0.02 mg/kg IV administered intraoperatively
Fentanyl: 100 mcg IV administered intraoperatively
Acetaminophen: 1000 mg IV administered intraoperatively
Oxycodone: 5-10 mg PO administered post-surgery
|
Placebo for Cohort 1
n=9 Participants
Cohort 1:
Placebo comparator is identical in appearance to the investigational product, containing the same excipients as the active comparator.
The surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).
Placebo: Each cohort will use placebo reconstituted in saline.
Bupivacaine Hydrochloride: 0.25% administered pre-surgery
Hydromorphone: 0.02 mg/kg IV administered intraoperatively
Fentanyl: 100 mcg IV administered intraoperatively
Acetaminophen: 1000 mg IV administered intraoperatively
Oxycodone: 5-10 mg PO administered post-surgery
|
CA-008 10 mg (0.1 mg/mL)
n=12 Participants
Cohort 2 (CA-008 10 mg): the surgery is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).
Bupivacaine Hydrochloride: 0.25% administered pre-surgery
Hydromorphone: 0.02 mg/kg IV administered intraoperatively
Fentanyl: 100 mcg IV administered intraoperatively
Acetaminophen: 1000 mg IV administered intraoperatively
Oxycodone: 5-10 mg PO administered post-surgery
CA-008 10 mg: 10 mg CA-008 reconstituted in saline.
|
CA-008 15 mg (0.15 mg/mL)
n=12 Participants
Cohort 3 (CA-008 15 mg): the surgery is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).
Bupivacaine Hydrochloride: 0.25% administered pre-surgery
Hydromorphone: 0.02 mg/kg IV administered intraoperatively
Fentanyl: 100 mcg IV administered intraoperatively
Acetaminophen: 1000 mg IV administered intraoperatively
Oxycodone: 5-10 mg PO administered post-surgery
CA-008 15 mg: 15 mg CA-008 reconstituted in saline.
|
Placebo for Cohorts 2 and 3
n=12 Participants
Cohorts 2 \& 3:
Placebo comparator in each cohort is identical in appearance to the investigational product, containing the same excipients as the active comparator.
The surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).
Placebo: Each cohort will use placebo reconstituted in saline.
Bupivacaine Hydrochloride: 0.25% administered pre-surgery
Hydromorphone: 0.02 mg/kg IV administered intraoperatively
Fentanyl: 100 mcg IV administered intraoperatively
Acetaminophen: 1000 mg IV administered intraoperatively
Oxycodone: 5-10 mg PO administered post-surgery
|
|---|---|---|---|---|---|
|
Percent of Opioid Free Subjects
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 0 to 96 hoursPopulation: Safety population
The sum of daily opioid consumption (in morphine equivalents)
Outcome measures
| Measure |
CA-008 5 mg (0.05 mg/mL) Cohort 1
n=9 Participants
Cohort 1 (CA-008 5 mg): the surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).
CA-008 5 mg: 5 mg CA-008 reconstituted in saline.
Bupivacaine Hydrochloride: 0.25% administered pre-surgery
Hydromorphone: 0.02 mg/kg IV administered intraoperatively
Fentanyl: 100 mcg IV administered intraoperatively
Acetaminophen: 1000 mg IV administered intraoperatively
Oxycodone: 5-10 mg PO administered post-surgery
|
Placebo for Cohort 1
n=9 Participants
Cohort 1:
Placebo comparator is identical in appearance to the investigational product, containing the same excipients as the active comparator.
The surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).
Placebo: Each cohort will use placebo reconstituted in saline.
Bupivacaine Hydrochloride: 0.25% administered pre-surgery
Hydromorphone: 0.02 mg/kg IV administered intraoperatively
Fentanyl: 100 mcg IV administered intraoperatively
Acetaminophen: 1000 mg IV administered intraoperatively
Oxycodone: 5-10 mg PO administered post-surgery
|
CA-008 10 mg (0.1 mg/mL)
n=12 Participants
Cohort 2 (CA-008 10 mg): the surgery is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).
Bupivacaine Hydrochloride: 0.25% administered pre-surgery
Hydromorphone: 0.02 mg/kg IV administered intraoperatively
Fentanyl: 100 mcg IV administered intraoperatively
Acetaminophen: 1000 mg IV administered intraoperatively
Oxycodone: 5-10 mg PO administered post-surgery
CA-008 10 mg: 10 mg CA-008 reconstituted in saline.
|
CA-008 15 mg (0.15 mg/mL)
n=12 Participants
Cohort 3 (CA-008 15 mg): the surgery is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).
Bupivacaine Hydrochloride: 0.25% administered pre-surgery
Hydromorphone: 0.02 mg/kg IV administered intraoperatively
Fentanyl: 100 mcg IV administered intraoperatively
Acetaminophen: 1000 mg IV administered intraoperatively
Oxycodone: 5-10 mg PO administered post-surgery
CA-008 15 mg: 15 mg CA-008 reconstituted in saline.
|
Placebo for Cohorts 2 and 3
n=12 Participants
Cohorts 2 \& 3:
Placebo comparator in each cohort is identical in appearance to the investigational product, containing the same excipients as the active comparator.
The surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).
Placebo: Each cohort will use placebo reconstituted in saline.
Bupivacaine Hydrochloride: 0.25% administered pre-surgery
Hydromorphone: 0.02 mg/kg IV administered intraoperatively
Fentanyl: 100 mcg IV administered intraoperatively
Acetaminophen: 1000 mg IV administered intraoperatively
Oxycodone: 5-10 mg PO administered post-surgery
|
|---|---|---|---|---|---|
|
Total Opioid Consumption
|
85.83 mg morphine equivalents
Standard Deviation 52.246
|
96.67 mg morphine equivalents
Standard Deviation 63.134
|
69.77 mg morphine equivalents
Standard Deviation 41.710
|
58.00 mg morphine equivalents
Standard Deviation 69.170
|
77.85 mg morphine equivalents
Standard Deviation 72.524
|
Adverse Events
CA-008 5 mg (0.05 mg/mL) Cohort 1
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo for Cohort 1
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
CA-008 10 mg (0.1 mg/mL)
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
CA-008 15 mg (0.15 mg/mL)
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo for Cohorts 2 and 3
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CA-008 5 mg (0.05 mg/mL) Cohort 1
n=9 participants at risk
Cohort 1 (CA-008 5 mg): the surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).
CA-008 5 mg: 5 mg CA-008 reconstituted in saline.
Bupivacaine Hydrochloride: 0.25% administered pre-surgery
Hydromorphone: 0.02 mg/kg IV administered intraoperatively
Fentanyl: 100 mcg IV administered intraoperatively
Acetaminophen: 1000 mg IV administered intraoperatively
Oxycodone: 5-10 mg PO administered post-surgery
|
Placebo for Cohort 1
n=9 participants at risk
Cohort 1:
Placebo comparator is identical in appearance to the investigational product, containing the same excipients as the active comparator.
The surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).
Placebo: Each cohort will use placebo reconstituted in saline.
Bupivacaine Hydrochloride: 0.25% administered pre-surgery
Hydromorphone: 0.02 mg/kg IV administered intraoperatively
Fentanyl: 100 mcg IV administered intraoperatively
Acetaminophen: 1000 mg IV administered intraoperatively
Oxycodone: 5-10 mg PO administered post-surgery
|
CA-008 10 mg (0.1 mg/mL)
n=12 participants at risk
Cohort 2 (CA-008 10 mg): the surgery is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).
Bupivacaine Hydrochloride: 0.25% administered pre-surgery
Hydromorphone: 0.02 mg/kg IV administered intraoperatively
Fentanyl: 100 mcg IV administered intraoperatively
Acetaminophen: 1000 mg IV administered intraoperatively
Oxycodone: 5-10 mg PO administered post-surgery
CA-008 10 mg: 10 mg CA-008 reconstituted in saline.
|
CA-008 15 mg (0.15 mg/mL)
n=12 participants at risk
Cohort 3 (CA-008 15 mg): the surgery is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).
Bupivacaine Hydrochloride: 0.25% administered pre-surgery
Hydromorphone: 0.02 mg/kg IV administered intraoperatively
Fentanyl: 100 mcg IV administered intraoperatively
Acetaminophen: 1000 mg IV administered intraoperatively
Oxycodone: 5-10 mg PO administered post-surgery
CA-008 15 mg: 15 mg CA-008 reconstituted in saline.
|
Placebo for Cohorts 2 and 3
n=12 participants at risk
Cohorts 2 \& 3:
Placebo comparator in each cohort is identical in appearance to the investigational product, containing the same excipients as the active comparator.
The surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).
Placebo: Each cohort will use placebo reconstituted in saline.
Bupivacaine Hydrochloride: 0.25% administered pre-surgery
Hydromorphone: 0.02 mg/kg IV administered intraoperatively
Fentanyl: 100 mcg IV administered intraoperatively
Acetaminophen: 1000 mg IV administered intraoperatively
Oxycodone: 5-10 mg PO administered post-surgery
|
|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/9 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/9 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
8.3%
1/12 • Number of events 1 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
8.3%
1/12 • Number of events 1 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
11.1%
1/9 • Number of events 1 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/9 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
|
Vascular disorders
Deep vein thrombosis
|
11.1%
1/9 • Number of events 1 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/9 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
Other adverse events
| Measure |
CA-008 5 mg (0.05 mg/mL) Cohort 1
n=9 participants at risk
Cohort 1 (CA-008 5 mg): the surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).
CA-008 5 mg: 5 mg CA-008 reconstituted in saline.
Bupivacaine Hydrochloride: 0.25% administered pre-surgery
Hydromorphone: 0.02 mg/kg IV administered intraoperatively
Fentanyl: 100 mcg IV administered intraoperatively
Acetaminophen: 1000 mg IV administered intraoperatively
Oxycodone: 5-10 mg PO administered post-surgery
|
Placebo for Cohort 1
n=9 participants at risk
Cohort 1:
Placebo comparator is identical in appearance to the investigational product, containing the same excipients as the active comparator.
The surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).
Placebo: Each cohort will use placebo reconstituted in saline.
Bupivacaine Hydrochloride: 0.25% administered pre-surgery
Hydromorphone: 0.02 mg/kg IV administered intraoperatively
Fentanyl: 100 mcg IV administered intraoperatively
Acetaminophen: 1000 mg IV administered intraoperatively
Oxycodone: 5-10 mg PO administered post-surgery
|
CA-008 10 mg (0.1 mg/mL)
n=12 participants at risk
Cohort 2 (CA-008 10 mg): the surgery is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).
Bupivacaine Hydrochloride: 0.25% administered pre-surgery
Hydromorphone: 0.02 mg/kg IV administered intraoperatively
Fentanyl: 100 mcg IV administered intraoperatively
Acetaminophen: 1000 mg IV administered intraoperatively
Oxycodone: 5-10 mg PO administered post-surgery
CA-008 10 mg: 10 mg CA-008 reconstituted in saline.
|
CA-008 15 mg (0.15 mg/mL)
n=12 participants at risk
Cohort 3 (CA-008 15 mg): the surgery is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).
Bupivacaine Hydrochloride: 0.25% administered pre-surgery
Hydromorphone: 0.02 mg/kg IV administered intraoperatively
Fentanyl: 100 mcg IV administered intraoperatively
Acetaminophen: 1000 mg IV administered intraoperatively
Oxycodone: 5-10 mg PO administered post-surgery
CA-008 15 mg: 15 mg CA-008 reconstituted in saline.
|
Placebo for Cohorts 2 and 3
n=12 participants at risk
Cohorts 2 \& 3:
Placebo comparator in each cohort is identical in appearance to the investigational product, containing the same excipients as the active comparator.
The surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg).
Placebo: Each cohort will use placebo reconstituted in saline.
Bupivacaine Hydrochloride: 0.25% administered pre-surgery
Hydromorphone: 0.02 mg/kg IV administered intraoperatively
Fentanyl: 100 mcg IV administered intraoperatively
Acetaminophen: 1000 mg IV administered intraoperatively
Oxycodone: 5-10 mg PO administered post-surgery
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
33.3%
3/9 • Number of events 3 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
22.2%
2/9 • Number of events 2 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
8.3%
1/12 • Number of events 1 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
16.7%
2/12 • Number of events 2 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
33.3%
4/12 • Number of events 4 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/9 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/9 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
8.3%
1/12 • Number of events 1 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/9 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/9 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
8.3%
1/12 • Number of events 1 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
|
Gastrointestinal disorders
Lip oedema
|
0.00%
0/9 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/9 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
8.3%
1/12 • Number of events 1 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
|
Gastrointestinal disorders
Nausea
|
55.6%
5/9 • Number of events 5 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
88.9%
8/9 • Number of events 8 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
50.0%
6/12 • Number of events 6 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
41.7%
5/12 • Number of events 5 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
25.0%
3/12 • Number of events 3 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/9 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/9 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
8.3%
1/12 • Number of events 1 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/9 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
22.2%
2/9 • Number of events 2 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
16.7%
2/12 • Number of events 2 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/9 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/9 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
8.3%
1/12 • Number of events 1 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
|
Infections and infestations
Incision site cellulitis
|
11.1%
1/9 • Number of events 1 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/9 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
8.3%
1/12 • Number of events 1 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/9 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/9 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
8.3%
1/12 • Number of events 1 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/9 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/9 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
8.3%
1/12 • Number of events 1 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
|
Injury, poisoning and procedural complications
Abdominal wound dehiscence
|
0.00%
0/9 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/9 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
8.3%
1/12 • Number of events 1 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
|
Injury, poisoning and procedural complications
Airway complication of anaesthesia
|
0.00%
0/9 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/9 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
8.3%
1/12 • Number of events 1 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/9 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/9 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
8.3%
1/12 • Number of events 1 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
|
Injury, poisoning and procedural complications
Flap necrosis
|
0.00%
0/9 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/9 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
8.3%
1/12 • Number of events 1 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
8.3%
1/12 • Number of events 1 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
|
Injury, poisoning and procedural complications
Incision site pruritus
|
0.00%
0/9 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/9 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
8.3%
1/12 • Number of events 1 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/9 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/9 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
8.3%
1/12 • Number of events 1 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/9 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/9 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
8.3%
1/12 • Number of events 1 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
8.3%
1/12 • Number of events 1 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
|
Injury, poisoning and procedural complications
Seroma
|
11.1%
1/9 • Number of events 1 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/9 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/9 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
11.1%
1/9 • Number of events 1 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
|
Investigations
Transaminases increased
|
0.00%
0/9 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/9 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
8.3%
1/12 • Number of events 1 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
8.3%
1/12 • Number of events 1 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
3/9 • Number of events 3 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
44.4%
4/9 • Number of events 4 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
25.0%
3/12 • Number of events 3 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
33.3%
4/12 • Number of events 4 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
41.7%
5/12 • Number of events 5 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/9 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/9 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
8.3%
1/12 • Number of events 1 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/9 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/9 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
8.3%
1/12 • Number of events 1 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/9 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/9 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
8.3%
1/12 • Number of events 1 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
|
Nervous system disorders
Headache
|
44.4%
4/9 • Number of events 4 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
11.1%
1/9 • Number of events 1 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
8.3%
1/12 • Number of events 1 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
16.7%
2/12 • Number of events 2 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
16.7%
2/12 • Number of events 2 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
|
Nervous system disorders
Sciatica
|
0.00%
0/9 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/9 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
8.3%
1/12 • Number of events 1 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
11.1%
1/9 • Number of events 1 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/9 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/9 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/9 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
8.3%
1/12 • Number of events 1 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/9 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/9 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
16.7%
2/12 • Number of events 2 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/9 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/9 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
8.3%
1/12 • Number of events 1 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
11.1%
1/9 • Number of events 1 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
11.1%
1/9 • Number of events 1 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
8.3%
1/12 • Number of events 1 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
8.3%
1/12 • Number of events 1 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/9 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/9 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
8.3%
1/12 • Number of events 1 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/9 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/9 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
8.3%
1/12 • Number of events 1 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/9 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/9 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
8.3%
1/12 • Number of events 1 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/9 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
11.1%
1/9 • Number of events 1 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
8.3%
1/12 • Number of events 1 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
8.3%
1/12 • Number of events 1 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
|
Skin and subcutaneous tissue disorders
Pruritus generalized
|
11.1%
1/9 • Number of events 1 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/9 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
8.3%
1/12 • Number of events 1 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.1%
1/9 • Number of events 1 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/9 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
8.3%
1/12 • Number of events 1 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/9 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/9 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
8.3%
1/12 • Number of events 1 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
|
Vascular disorders
Deep vein thrombosis
|
11.1%
1/9 • Number of events 1 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/9 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
|
Vascular disorders
Phlebitis
|
11.1%
1/9 • Number of events 1 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/9 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
0.00%
0/12 • Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place