Trial Outcomes & Findings for Phase 3 Study of Local Administration of SKY0402 for Postoperative Analgesia in Subject Undergoing Breast Augmentation (NCT NCT00813111)

Last Updated: 2014-01-16

Results Overview

Assessments of postoperative pain included pain intensity at rest (using the NRS at rest \[NRS-R\] and with activity \[using the NRS-A\]) where the prescribed activity was raising both arms. Pain intensity was assessed on a scale of 0 to 10, where 0=no pain and 10=worst possible pain.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

136 participants

Primary outcome timeframe

through 72 hours

Results posted on

2014-01-16

Participant Flow

Participant milestones

Participant milestones
Measure	SKY0402 A single local administration of 300 mg in a 20-mL volume into each breast implant pocket for a total dose of 600 mg (i.e., a total of 40 mL)	Bupivacaine HCl A single local administration of 100 mg in a 20-mL volume into each breast implant pocket for a total dose of 200 mg (i.e., a total of 40 mL)
Overall Study STARTED	66	70
Overall Study COMPLETED	64	70
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase 3 Study of Local Administration of SKY0402 for Postoperative Analgesia in Subject Undergoing Breast Augmentation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SKY0402 n=66 Participants A single local administration of 300 mg in a 20-mL volume into each breast implant pocket for a total dose of 600 mg (i.e., a total of 40 mL)	Bupivacaine HCl n=70 Participants A single local administration of 100 mg in a 20-mL volume into each breast implant pocket for a total dose of 200 mg (i.e., a total of 40 mL)	Total n=136 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	66 Participants n=5 Participants	70 Participants n=7 Participants	136 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	30.8 years STANDARD_DEVIATION 7.3 • n=5 Participants	30.6 years STANDARD_DEVIATION 7.6 • n=7 Participants	30.7 years STANDARD_DEVIATION 7.4 • n=5 Participants
Sex: Female, Male Female	66 Participants n=5 Participants	70 Participants n=7 Participants	136 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	66 participants n=5 Participants	70 participants n=7 Participants	136 participants n=5 Participants

PRIMARY outcome

Timeframe: through 72 hours

Population: Note: 136 subjects were randomized and received study drug and were included in the analyses. 10 subjects were randomized but not dosed and 4 additional subjects failed screening, resulting in 122 subjects.

Outcome measures

Outcome measures
Measure	SKY0402 n=60 Participants A single local administration of 300 mg in a 20-mL volume into each breast implant pocket for a total dose of 600 mg (i.e., a total of 40 mL)	Bupivacaine HCl n=62 Participants A single local administration of 100 mg in a 20-mL volume into each breast implant pocket for a total dose of 200 mg (i.e., a total of 40 mL)
Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) With Activity (NRS-A) Pain Intensity Scores	441 Units on a scale*hours Standard Deviation 163	467 Units on a scale*hours Standard Deviation 181

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Outcome data not reported

Adverse Events

SKY0402

Serious events: 0 serious events

Other events: 48 other events

Deaths: 0 deaths

Bupivacaine HCl

Serious events: 0 serious events

Other events: 51 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	SKY0402 n=66 participants at risk；n=64 participants at risk A single local administration of 300 mg in a 20-mL volume into each breast implant pocket for a total dose of 600 mg (i.e., a total of 40 mL)	Bupivacaine HCl n=70 participants at risk A single local administration of 100 mg in a 20-mL volume into each breast implant pocket for a total dose of 200 mg (i.e., a total of 40 mL)
Gastrointestinal disorders nausea	43.9% 29/66	52.9% 37/70
Gastrointestinal disorders vomiting	15.2% 10/66	20.0% 14/70
Gastrointestinal disorders Constipation	16.7% 11/66	18.6% 13/70
Musculoskeletal and connective tissue disorders Muscle Spasms	15.2% 10/66	15.7% 11/70
Musculoskeletal and connective tissue disorders Myalgia	9.1% 6/66	0.00% 0/70
General disorders Chills	6.1% 4/66	2.9% 2/70
Nervous system disorders Headache	3.0% 2/66	7.1% 5/70
Nervous system disorders Hypoaesthesia	6.1% 4/66	4.3% 3/70
Cardiac disorders Tachycardia	4.5% 3/66	10.0% 7/70
Psychiatric disorders Insomnia	9.1% 6/66	5.7% 4/70

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