Trial Outcomes & Findings for Evaluation of the Safety and Efficacy of a Single Dose of SKY0402 in Subjects Undergoing Augmentation Mammoplasty (NCT NCT01206608)
NCT ID: NCT01206608
Last Updated: 2021-03-02
Results Overview
Assessments of postoperative pain were conducted through 96 hours and included pain intensity at rest (NRS-R) and with activity (NRS-A). The prescribed activity was to consist of raising the arm, in full extension at the elbow and wrist, to a position parallel with the axis of the torso. Pain intensity was scored on an 11-point scale, where 0 = no pain and 10 = worst possible pain.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
Through 96 hours postdose
Results posted on
2021-03-02
Participant Flow
Participant milestones
| Measure |
Low-dose SKY0402 + Bupivacaine HCl
Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
|
Mid-dose SKY0402 + Bupivacaine HCl
Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of the Safety and Efficacy of a Single Dose of SKY0402 in Subjects Undergoing Augmentation Mammoplasty
Baseline characteristics by cohort
| Measure |
Low-dose SKY0402 + Bupivacaine HCl
n=20 Participants
Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
|
Mid-dose SKY0402 + Bupivacaine HCl
n=20 Participants
Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
|
Total
n=40 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
|
20 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
30.7 years
STANDARD_DEVIATION 7 • n=99 Participants
|
28.4 years
STANDARD_DEVIATION 6 • n=107 Participants
|
29.6 years
STANDARD_DEVIATION 6.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=99 Participants
|
20 participants
n=107 Participants
|
40 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Through 96 hours postdoseAssessments of postoperative pain were conducted through 96 hours and included pain intensity at rest (NRS-R) and with activity (NRS-A). The prescribed activity was to consist of raising the arm, in full extension at the elbow and wrist, to a position parallel with the axis of the torso. Pain intensity was scored on an 11-point scale, where 0 = no pain and 10 = worst possible pain.
Outcome measures
| Measure |
Low-dose SKY0402 (150mg) + Bupivacaine HCl
n=20 Participants
Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402. A single dose of 150mg SKY0402 administration via local infiltration.
|
Mid-dose SKY0402 (300mg)+ Bupivacaine HCl
n=20 Participants
Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402. A single dose of 150mg SKY0402 administration via local infiltration.
|
|---|---|---|
|
Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) at Rest (NRS-R) and With Activity (NRS-A) Pain Intensity Scores
|
340.7 Units on a scale*hours
Standard Deviation 141.6
|
293.4 Units on a scale*hours
Standard Deviation 194.2
|
SECONDARY outcome
Timeframe: Through 30 days postdoseAdverse events were monitored through Day 8 and serious adverse events through Day 30.
Outcome measures
Outcome data not reported
Adverse Events
Low-dose SKY0402 + Bupivacaine HCl
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Mid-dose SKY0402 + Bupivacaine HCl
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Low-dose SKY0402 + Bupivacaine HCl
n=20 participants at risk
Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
|
Mid-dose SKY0402 + Bupivacaine HCl
n=20 participants at risk
Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
|
|---|---|---|
|
Injury, poisoning and procedural complications
Postprocedural hematoma
|
0.00%
0/20
|
5.0%
1/20
|
Other adverse events
| Measure |
Low-dose SKY0402 + Bupivacaine HCl
n=20 participants at risk
Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
|
Mid-dose SKY0402 + Bupivacaine HCl
n=20 participants at risk
Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
|
|---|---|---|
|
Cardiac disorders
Tachycardia
|
20.0%
4/20
|
0.00%
0/20
|
|
Gastrointestinal disorders
Constipation
|
40.0%
8/20
|
20.0%
4/20
|
|
Gastrointestinal disorders
Nausea
|
80.0%
16/20
|
65.0%
13/20
|
|
Gastrointestinal disorders
Vomiting
|
15.0%
3/20
|
15.0%
3/20
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
5/20
|
5.0%
1/20
|
|
Nervous system disorders
Dizziness
|
10.0%
2/20
|
5.0%
1/20
|
|
Nervous system disorders
Headache
|
20.0%
4/20
|
5.0%
1/20
|
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