Trial Outcomes & Findings for Evaluation of the Safety, Efficacy, and Pharmacokinetics of SKY0402 in Subjects Undergoing Inguinal Hernia Repair (NCT NCT01203644)
NCT ID: NCT01203644
Last Updated: 2021-01-25
Results Overview
The primary efficacy endpoint was the time to first use of supplemental pain medication (opioid or non-opioid) postoperatively for surgical wound pain
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
76 participants
Primary outcome timeframe
Through 96 hours postdose
Results posted on
2021-01-25
Participant Flow
Participant milestones
| Measure |
Bupivacaine HCl
(e.g., Marcaine with epinephrine 1:200,000) is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
|
SKY0402
Low dose, low-mid dose, mid-dose, and high dose
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
50
|
|
Overall Study
COMPLETED
|
26
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of the Safety, Efficacy, and Pharmacokinetics of SKY0402 in Subjects Undergoing Inguinal Hernia Repair
Baseline characteristics by cohort
| Measure |
Bupivacaine HCl
n=26 Participants
(e.g., Marcaine with epinephrine 1:200,000) is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
|
SKY0402
n=50 Participants
Low dose, low-mid dose, mid-dose, and high dose
|
Total
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Age, Continuous
|
51.3 years
STANDARD_DEVIATION 12.6 • n=99 Participants
|
55.1 years
STANDARD_DEVIATION 16 • n=107 Participants
|
53.8 years
STANDARD_DEVIATION 14.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
76 Participants
n=206 Participants
|
|
Region of Enrollment
Belgium
|
0 participants
n=99 Participants
|
8 participants
n=107 Participants
|
8 participants
n=206 Participants
|
|
Region of Enrollment
Australia
|
16 participants
n=99 Participants
|
26 participants
n=107 Participants
|
42 participants
n=206 Participants
|
|
Region of Enrollment
United Kingdom
|
4 participants
n=99 Participants
|
12 participants
n=107 Participants
|
16 participants
n=206 Participants
|
|
Region of Enrollment
Netherlands
|
6 participants
n=99 Participants
|
4 participants
n=107 Participants
|
10 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Through 96 hours postdoseThe primary efficacy endpoint was the time to first use of supplemental pain medication (opioid or non-opioid) postoperatively for surgical wound pain
Outcome measures
| Measure |
Bupivacaine HCl
n=26 Participants
(e.g., Marcaine with epinephrine 1:200,000) is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402. Single 100 mg administration of 0.25% solution (i.e., 0.5% diluted 1:1) in a 40-mL volume via local infiltration
|
SKY0402 Low Dose
n=12 Participants
Single administration of SKY0402 (low dose, 175 mg) in a 40-mL volume via local infiltration
|
SKY0402 Low-mid Dose
n=12 Participants
Single administration of SKY0402 (low-mid dose, 225 mg) in a 40-mL volume via local infiltration
|
SKY0402 High-mid Dose
n=12 Participants
Single administration of SKY0402 (high-mid dose, 300 mg) in a 40-mL volume via local infiltration
|
SKY0402 High Dose
n=14 Participants
Single administration of SKY0402 (high dose, 350 mg) in a 40-mL volume via local infiltration
|
|---|---|---|---|---|---|
|
Time to First Use of Supplemental Pain Medication
|
4.2 hours
Interval 1.3 to 13.7
|
13.75 hours
Interval 2.1 to 62.7
|
3.9 hours
Interval 0.8 to 7.4
|
5.2 hours
Interval 1.9 to 18.8
|
5.5 hours
Interval 1.4 to 96.0
|
SECONDARY outcome
Timeframe: Through 30 days postdoseSafety assessments included monitoring of treatment-emergent adverse events
Outcome measures
Outcome data not reported
Adverse Events
Bupivacaine HCl
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
SKY0402
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bupivacaine HCl
n=26 participants at risk
(e.g., Marcaine with epinephrine 1:200,000) is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
|
SKY0402
n=50 participants at risk
Low dose, low-mid dose, mid-dose, and high dose
|
|---|---|---|
|
Injury, poisoning and procedural complications
Postoperative hematoma
|
0.00%
0/26
|
2.0%
1/50
|
|
Renal and urinary disorders
Urinary Retention/BPH
|
0.00%
0/26
|
2.0%
1/50
|
Other adverse events
| Measure |
Bupivacaine HCl
n=26 participants at risk
(e.g., Marcaine with epinephrine 1:200,000) is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
|
SKY0402
n=50 participants at risk
Low dose, low-mid dose, mid-dose, and high dose
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
7.7%
2/26
|
8.0%
4/50
|
|
General disorders
Localized oedema
|
7.7%
2/26
|
2.0%
1/50
|
|
General disorders
Pyrexia
|
3.8%
1/26
|
6.0%
3/50
|
|
Infections and infestations
Wound infection
|
7.7%
2/26
|
0.00%
0/50
|
|
Renal and urinary disorders
Urinary retention
|
7.7%
2/26
|
2.0%
1/50
|
|
Vascular disorders
Hypertension NOS
|
3.8%
1/26
|
6.0%
3/50
|
Additional Information
Executive Medical Director
Pacira Pharmaceuticals, Inc.
Phone: 203-837-6500
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place