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Study of Postoperative Analgesia in Bunionectomy

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ClinicalTrials.gov Identifier: NCT00890682
Recruitment Status : Completed
First Posted : April 30, 2009
Results First Posted : August 5, 2013
Last Update Posted : August 5, 2013
Sponsor:
Information provided by (Responsible Party):
Pacira Pharmaceuticals, Inc

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Bunion
Hallux Valgus
Interventions Drug: SKY0402
Drug: Placebo
Enrollment 193
Recruitment Details  
Pre-assignment Details  
Arm/Group Title SKY0402 Placebo
Hide Arm/Group Description Injection of 8cc SKY0402 (single dose) Injection of 8cc Placebo (single dose)
Period Title: Overall Study
Started 97 96
Completed 93 94
Not Completed 4 2
Arm/Group Title Sky0402 Placebo Total
Hide Arm/Group Description Injection of Study Drug Study Drug Injection Total of all reporting groups
Overall Number of Baseline Participants 97 96 193
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 97 participants 96 participants 193 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
97
 100.0%
92
  95.8%
189
  97.9%
>=65 years
0
   0.0%
4
   4.2%
4
   2.1%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 97 participants 96 participants 193 participants
42.4  (12.6) 43.2  (13.3) 42.8  (13.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 97 participants 96 participants 193 participants
Female
75
  77.3%
84
  87.5%
159
  82.4%
Male
22
  22.7%
12
  12.5%
34
  17.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 97 participants 96 participants 193 participants
97 96 193
1.Primary Outcome
Title Area Under the Curve (AUC) of the Numeric Rating Scale at Rest (NRS-R) Pain Intensity Scores
Hide Description

The AUC of the NRS-R pain intensity scores from time 0 through 24 hours

The subject was to rest for at least 5 minutes before responding to the following question, “On a scale of 0 to 10, where 0 = no pain and 10 = worst possible pain, how much pain are you having right now?”

Time Frame 0-24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SKY0402 Placebo
Hide Arm/Group Description:
Single injection of study drug
Single injection of study drug
Overall Number of Participants Analyzed 97 96
Geometric Mean (Standard Error)
Unit of Measure: Units on a scale*hours
124  (4.5) 146  (4.6)
2.Secondary Outcome
Title Adverse Event Profile
Hide Description Participants with an Adverse Event through 72 hours or a Serious Adverse Event through 30 days
Time Frame 30 days
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sky0402 Placebo
Hide Arm/Group Description Injection of Study Drug Study Drug Injection
All-Cause Mortality
Sky0402 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Sky0402 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/97 (0.00%)      1/96 (1.04%)    
Vascular disorders     
Deep Vein Thrombosis  1  0/97 (0.00%)  0 1/96 (1.04%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sky0402 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   56/97 (57.73%)      63/96 (65.63%)    
Gastrointestinal disorders     
Nausea  1  39/97 (40.21%)  36/96 (37.50%) 
Vomiting  1  27/97 (27.84%)  17/96 (17.71%) 
Nervous system disorders     
Dizziness  1  11/97 (11.34%)  25/96 (26.04%) 
Headache  1  5/97 (5.15%)  8/96 (8.33%) 
Somnolence  1  5/97 (5.15%)  1/96 (1.04%)  1
Skin and subcutaneous tissue disorders     
Pruritis  1  5/97 (5.15%)  6/96 (6.25%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
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
Layout table for additonal information
Responsible Party: Pacira Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT00890682     History of Changes
Other Study ID Numbers: SKY0402C317
First Submitted: April 28, 2009
First Posted: April 30, 2009
Results First Submitted: November 21, 2011
Results First Posted: August 5, 2013
Last Update Posted: August 5, 2013