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Trial record 2 of 8 for:    CARISOPRODOL

A Study to Evaluate Two Formulations of Carisoprodol in Subjects With Musculoskeletal Spasm of the Lower Back

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: NCT00671502
Recruitment Status : Completed
First Posted : May 5, 2008
Results First Posted : November 9, 2011
Last Update Posted : November 9, 2011
Sponsor:
Information provided by (Responsible Party):
Meda Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Lower Back Pain
Interventions Drug: Carisoprodol SR
Drug: Placebo
Enrollment 840
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Carisoprodol 700mg Carisoprodol 500mg Tablet Placebo Tablet
Hide Arm/Group Description tablet experimental formulation tablet experimental formulation tablet placebo no experimental formulation
Period Title: Overall Study
Started 281 280 279
Completed 242 241 252
Not Completed 39 39 27
Arm/Group Title Carisoprodol 700mg Carisoprodol 500mg Tablet Placebo Tablet Total
Hide Arm/Group Description tablet experimental formulation tablet experimental formulation tablet placebo no experimental formulation Total of all reporting groups
Overall Number of Baseline Participants 281 280 279 840
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 281 participants 280 participants 279 participants 840 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
278
  98.9%
278
  99.3%
275
  98.6%
831
  98.9%
>=65 years
3
   1.1%
2
   0.7%
4
   1.4%
9
   1.1%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 281 participants 280 participants 279 participants 840 participants
40.3  (13.05) 41.4  (12.6) 40.9  (12.72) 40.9  (12.78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 281 participants 280 participants 279 participants 840 participants
Female
133
  47.3%
144
  51.4%
136
  48.7%
413
  49.2%
Male
148
  52.7%
136
  48.6%
143
  51.3%
427
  50.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 281 participants 280 participants 279 participants 840 participants
281 280 279 840
1.Primary Outcome
Title Subject Rating of Pain on a 100-point Visual Analog Scale (VAS)
Hide Description the scale used was from 0 to 100 mm. 0 equaled no pain and 100 equaled maximum pain.participants measure their pain before treatment and during treatment at each visit
Time Frame up to 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
efficacy analyses based on ITT population. LOCF used to impute missing data. To detect a 14% difference between the carisoprodol and placebo treated subjects, 196 ITTsubjects per group (alpha level 0.025,power 80%).Assuming 15% dropout rate, 226 subjects per group were needed.A total of678 subjects were required to achieve 584 ITT subjects.
Arm/Group Title Carisoprodol 500mg Tablets Carisoprodol 700mg Tablets Placebo Tablets
Hide Arm/Group Description:
carisoprodol 500mg tablets treatment arm
carisoprodol 700mg tablets treatment arm
placebo tablets treatment arm
Overall Number of Participants Analyzed 280 281 279
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mm
27.5
(-21 to 83)
28
(-19 to 89)
28.6
(-36 to 82)
2.Secondary Outcome
Title Subject Functional Assessment Based on the Roland-Morris Disability Questionnaire (RMDQ)
Hide Description [Not Specified]
Time Frame up to 14 days
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Adverse Event Assessment
Hide Description the number of adverse events reported during the course of the study as reported by the participants
Time Frame up to 21 days
Outcome Measure Data Not Reported
Time Frame up to 21 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Carisoprodol 700mg Carisoprodol 500mg Tablet Placebo Tablet
Hide Arm/Group Description tablet experimental formulation tablet experimental formulation tablet placebo no experimental formulation
All-Cause Mortality
Carisoprodol 700mg Carisoprodol 500mg Tablet Placebo Tablet
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Carisoprodol 700mg Carisoprodol 500mg Tablet Placebo Tablet
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/278 (0.00%)      1/280 (0.36%)      0/275 (0.00%)    
Cardiac disorders       
transient ischemic attack  1 [1]  0/278 (0.00%)  0 1/280 (0.36%)  1 0/275 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MeDRA
[1]
occurred after discontinuation of drug therefore not considered treatment emergent
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.7%
Carisoprodol 700mg Carisoprodol 500mg Tablet Placebo Tablet
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   78/278 (28.06%)      65/280 (23.21%)      37/275 (13.45%)    
Gastrointestinal disorders       
nausea * 1  5/278 (1.80%)  5 12/280 (4.29%)  12 6/275 (2.18%)  6
General disorders       
fatigue * 1  5/278 (1.80%)  5 5/280 (1.79%)  5 2/275 (0.73%)  2
headache * 1  8/278 (2.88%)  8 4/280 (1.43%)  4 5/275 (1.82%)  5
Nervous system disorders       
somnolence * 1  44/44 (100.00%)  44 36/280 (12.86%)  36 18/275 (6.55%)  18
dizziness * 1  23/278 (8.27%)  23 12/280 (4.29%)  12 6/275 (2.18%)  6
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MeDRA
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: David Ginsberg, MD Sr Medical Director
Organization: Meda Pharma US
Phone: 732 564 2364
EMail: david.ginsberg@meda.us
Layout table for additonal information
Responsible Party: Meda Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00671502     History of Changes
Other Study ID Numbers: MP510
First Submitted: May 1, 2008
First Posted: May 5, 2008
Results First Submitted: June 28, 2011
Results First Posted: November 9, 2011
Last Update Posted: November 9, 2011