Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Dose-ranging Study for Postoperative Analgesia in Subjects Undergoing Primary Unilateral Inguinal Hernia Repair

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: NCT00485433
Recruitment Status : Completed
First Posted : June 13, 2007
Results First Posted : August 6, 2013
Last Update Posted : August 6, 2013
Sponsor:
Information provided by (Responsible Party):
Pacira Pharmaceuticals, Inc

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor)
Condition Postoperative Pain
Interventions Drug: Bupivacaine HCl
Drug: SKY0402
Enrollment 98
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bupivacaine HCl 105mg SKY0402 Low Dose SKY0402 Middle Dose SKY0402 High Dose
Hide Arm/Group Description Bupivacaine HCl given during hernia repair SKY0402 low dose given during hernia repair SKY0402 middle dose given during hernia repair SKY0402 high dose given during hernia repair
Period Title: Overall Study
Started 24 25 24 25
Completed 24 25 24 25
Not Completed 0 0 0 0
Arm/Group Title Bupivacaine HCl 105mg SKY0402 Low Dose SKY0402 Middle Dose SKY0402 High Dose Total
Hide Arm/Group Description Bupivacaine HCl given during hernia repair SKY0402 low dose given during hernia repair SKY0402 middle dose given during hernia repair SKY0402 high dose given during hernia repair Total of all reporting groups
Overall Number of Baseline Participants 24 25 24 25 98
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 25 participants 24 participants 25 participants 98 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
21
  87.5%
19
  76.0%
18
  75.0%
21
  84.0%
79
  80.6%
>=65 years
3
  12.5%
6
  24.0%
6
  25.0%
4
  16.0%
19
  19.4%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants 25 participants 24 participants 25 participants 98 participants
47.3  (16.9) 51.2  (17.3) 54  (15.1) 52.1  (15.6) 51.1  (16.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 25 participants 24 participants 25 participants 98 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
24
 100.0%
25
 100.0%
24
 100.0%
25
 100.0%
98
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 24 participants 25 participants 24 participants 25 participants 98 participants
24 25 24 25 98
1.Primary Outcome
Title Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) With Activity (NRS-A) Pain Intensity Scores From 0 Through 72 Hours
Hide Description The subject's pain intensity was to be assessed with activity (NRS-A), after the subject had moved himself from a supine position in bed to a sitting up position at the edge of the bed. The subject was to respond to the following question: "On a scale of 0 to 10, where 0=no pain and 10=worst possible pain, how much pain did you have while sitting up?"
Time Frame 0 to 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bupivacaine HCl 105mg SKY0402 Low Dose SKY0402 Middle Dose SKY0402 High Dose
Hide Arm/Group Description:
A single dose of 105 mg bupivacaine in a 42-mL injection volume administered via local infiltration during surgery
A single dose of SKY0402 diluted to a 42-mL injection volume administered via local infiltration during surgery
A single dose of SKY0402 diluted to a 42-mL injection volume administered via local infiltration during surgery
A single dose of SKY0402 diluted to a 42-mL injection volume administered via local infiltration during surgery
Overall Number of Participants Analyzed 24 25 24 25
Mean (Standard Deviation)
Unit of Measure: Units on a scale*hours
298.1  (136.6) 286.9  (146.4) 274.6  (115.4) 274.4  (253.4)
2.Secondary Outcome
Title Number of Participants With Adverse Events Through 96 Hours or Serious Adverse Events Through 30 Days
Hide Description [Not Specified]
Time Frame Up to 30 days
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bupivacaine HCl 105mg SKY0402 (All Doses)
Hide Arm/Group Description Bupivacaine HCl given during hernia repair SKY0402 given during hernia repair
All-Cause Mortality
Bupivacaine HCl 105mg SKY0402 (All Doses)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Bupivacaine HCl 105mg SKY0402 (All Doses)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/24 (0.00%)      1/74 (1.35%)    
Injury, poisoning and procedural complications     
Scar  1 [1]  0/24 (0.00%)  0 1/74 (1.35%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
[1]
Occurred in the Low Dose group
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Bupivacaine HCl 105mg SKY0402 (All Doses)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/24 (41.67%)      17/74 (22.97%)    
Cardiac disorders     
Bradycardia  1  0/24 (0.00%)  0 4/74 (5.41%) 
Gastrointestinal disorders     
Nausea  1  5/24 (20.83%)  6/74 (8.11%) 
Constipation  1  2/24 (8.33%)  7/74 (9.46%) 
Nervous system disorders     
Dizziness  1  2/24 (8.33%)  6/74 (8.11%) 
Hypoaesthesia  1  2/24 (8.33%)  1/74 (1.35%)  1
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: NCT00485433    
Other Study ID Numbers: SKY0402-C-207
First Submitted: June 11, 2007
First Posted: June 13, 2007
Results First Submitted: November 23, 2011
Results First Posted: August 6, 2013
Last Update Posted: August 6, 2013