We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00813111
Recruitment Status : Terminated (Sponsor decision, unrelated to safety)
First Posted : December 22, 2008
Results First Posted : January 16, 2014
Last Update Posted : January 16, 2014
Sponsor:
Information provided by (Responsible Party):
Pacira Pharmaceuticals, Inc

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Care Provider, Investigator);   Primary Purpose: Supportive Care
Condition Pain
Interventions Drug: SKY0402
Drug: Bupivacaine HCl
Enrollment 136
Recruitment Details  
Pre-assignment Details  
Arm/Group Title SKY0402 Bupivacaine HCl
Hide Arm/Group Description 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) 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)
Period Title: Overall Study
Started 66 70
Completed 64 70
Not Completed 2 0
Arm/Group Title SKY0402 Bupivacaine HCl Total
Hide Arm/Group Description 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) 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 of all reporting groups
Overall Number of Baseline Participants 66 70 136
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 66 participants 70 participants 136 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
66
 100.0%
70
 100.0%
136
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 66 participants 70 participants 136 participants
30.8  (7.3) 30.6  (7.6) 30.7  (7.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 66 participants 70 participants 136 participants
Female
66
 100.0%
70
 100.0%
136
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 66 participants 70 participants 136 participants
66 70 136
1.Primary Outcome
Title Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) With Activity (NRS-A) Pain Intensity Scores
Hide Description

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.
Time Frame through 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title SKY0402 Bupivacaine HCl
Hide Arm/Group Description:
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)
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 Number of Participants Analyzed 60 62
Mean (Standard Deviation)
Unit of Measure: Units on a scale*hours
441  (163) 467  (181)
2.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description [Not Specified]
Time Frame 30 days
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title SKY0402 Bupivacaine HCl
Hide Arm/Group Description 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) 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)
All-Cause Mortality
SKY0402 Bupivacaine HCl
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
SKY0402 Bupivacaine HCl
Affected / at Risk (%) Affected / at Risk (%)
Total   0/64 (0.00%)   0/70 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
SKY0402 Bupivacaine HCl
Affected / at Risk (%) Affected / at Risk (%)
Total   48/66 (72.73%)   51/70 (72.86%) 
Cardiac disorders     
Tachycardia  3/66 (4.55%)  7/70 (10.00%) 
Gastrointestinal disorders     
nausea  29/66 (43.94%)  37/70 (52.86%) 
vomiting  10/66 (15.15%)  14/70 (20.00%) 
Constipation  11/66 (16.67%)  13/70 (18.57%) 
General disorders     
Chills  4/66 (6.06%)  2/70 (2.86%) 
Musculoskeletal and connective tissue disorders     
Muscle Spasms  10/66 (15.15%)  11/70 (15.71%) 
Myalgia  6/66 (9.09%)  0/70 (0.00%) 
Nervous system disorders     
Headache  2/66 (3.03%)  5/70 (7.14%) 
Hypoaesthesia  4/66 (6.06%)  3/70 (4.29%) 
Psychiatric disorders     
Insomnia  6/66 (9.09%)  4/70 (5.71%) 
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Executive Medical Director
Organization: Pacira Pharmaceuticals, Inc.
Phone: 203-837-6500
EMail: ErolOnel@pacira.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Pacira Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT00813111    
Other Study ID Numbers: SIMPLE Breast Augmentation 315
First Submitted: December 9, 2008
First Posted: December 22, 2008
Results First Submitted: November 22, 2011
Results First Posted: January 16, 2014
Last Update Posted: January 16, 2014