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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: NCT00671879
Recruitment Status : Completed
First Posted : May 5, 2008
Results First Posted : November 21, 2012
Last Update Posted : November 21, 2012
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 700 mg
Drug: Carisoprodol SR 500 mg
Drug: Placebo
Enrollment 830
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Carisprodol SR 700 mg Carisoprodol SR 500mg Placebo
Hide Arm/Group Description Carisoprodol 700 mg twice daily Carisoprodol SR 500 mg twice daily Placebo treatment arm
Period Title: Overall Study
Started 281 279 280
Completed 281 275 274
Not Completed 0 4 6
Reason Not Completed
Withdrawal by Subject             0             4             6
Arm/Group Title Carisprodol SR 700 mg Carisoprodol SR 500mg Placebo Total
Hide Arm/Group Description Carisoprodol 700 mg twice daily Carisoprodol SR 500 mg twice daily Placebo treatment arm Total of all reporting groups
Overall Number of Baseline Participants 281 279 280 840
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 281 participants 279 participants 280 participants 840 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
279
  99.3%
279
 100.0%
280
 100.0%
838
  99.8%
>=65 years
2
   0.7%
0
   0.0%
0
   0.0%
2
   0.2%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 281 participants 279 participants 280 participants 840 participants
41.5  (12.35) 41.6  (11.79) 41.4  (11.86) 41.5  (12.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 281 participants 279 participants 280 participants 840 participants
Female
149
  53.0%
145
  52.0%
144
  51.4%
438
  52.1%
Male
132
  47.0%
134
  48.0%
136
  48.6%
402
  47.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 281 participants 279 participants 280 participants 840 participants
281 279 280 840
1.Primary Outcome
Title Subject Rated Change Relief From Starting Backache of Pain on a 100-point Visual Analog Scale
Hide Description on a visual analog scale of 0 to 100 millimeters(mm) with 0 being no pain and 100 being maximum pain By measuring the amount of pain before and during treatment done at each visit and recording the difference in mm.During treatment scores were averaged and this average was compared to the baseline value.
Time Frame baseline to 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
intent to treat(ITT) population least square mean(LSMEAN, LSMEAN) diff vs Placebo
Arm/Group Title Carisprodol SR 700 mg Carisoprodol SR 500mg Placebo
Hide Arm/Group Description:
Carisoprodol SR 700 mg twice daily
Carisoprodol SR 500 mg twice daily
Placebo treatment arm
Overall Number of Participants Analyzed 270 271 264
Least Squares Mean (Standard Deviation)
Unit of Measure: mm
16.4  (1.30) 15.5  (1.34) 15.2  (1.32)
2.Secondary Outcome
Title Subject Functional Assessment Based on the Roland-Morris Disability Questionnaire (RMDQ)
Hide Description Subject functional assessment based on the Roland-Morris Disability Questionnaire (RMDQ)at day 14.Subjects were asked to read a list of 24 sentences that people have used to describe themselves when they had back pain, and were asked to mark those statements that described their condition that day. The number of marked statements was added. A decrease in the number of marked statements from baseline represented improvement on the RMDQ.
Time Frame baseline and day +14
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat(ITT) population
Arm/Group Title Carisprodol SR 700 mg Carisoprodol SR 500mg Placebo
Hide Arm/Group Description:
Carisoprodol 700 mg twice daily
Carisoprodol SR 500 mg twice daily
Placebo treatment arm
Overall Number of Participants Analyzed 135 141 142
Least Squares Mean (Standard Error)
Unit of Measure: marked statements
4.2  (0.64) 5.0  (0.64) 4.3  (0.65)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Carisprodol SR 700 mg Carisoprodol SR 500mg Placebo
Hide Arm/Group Description Carisoprodol 700 mg twice daily Carisoprodol SR 500 mg twice daily Placebo treatment arm
All-Cause Mortality
Carisprodol SR 700 mg Carisoprodol SR 500mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Carisprodol SR 700 mg Carisoprodol SR 500mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/281 (0.00%)      3/275 (1.09%)      0/274 (0.00%)    
Infections and infestations       
atypical pneumonitis * 1  0/281 (0.00%)  0 1/275 (0.36%)  1 0/274 (0.00%)  0
severe influenza * 1  0/281 (0.00%)  0 1/275 (0.36%)  1 0/274 (0.00%)  0
Vascular disorders       
stroke * 1  0/281 (0.00%)  0 1/275 (0.36%)  1 0/274 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (11.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.4%
Carisprodol SR 700 mg Carisoprodol SR 500mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   98/281 (34.88%)      94/275 (34.18%)      49/274 (17.88%)    
Blood and lymphatic system disorders       
increased blood CPK * 1  4/281 (1.42%)  4 3/275 (1.09%)  3 4/274 (1.46%)  4
Gastrointestinal disorders       
nausea * 1  14/281 (4.98%)  14 7/275 (2.55%)  7 1/274 (0.36%)  1
constipation * 1  3/281 (1.07%)  3 2/275 (0.73%)  2 2/274 (0.73%)  2
diarrhea * 1  3/281 (1.07%)  3 2/275 (0.73%)  2 1/274 (0.36%)  1
vomiting * 1  4/281 (1.42%)  4 1/275 (0.36%)  1 0/274 (0.00%)  0
General disorders       
fatigue * 1  4/281 (1.42%)  4 6/275 (2.18%)  6 2/274 (0.73%)  2
dry mouth * 1  1/281 (0.36%)  1 4/275 (1.45%)  4 0/274 (0.00%)  0
Musculoskeletal and connective tissue disorders       
clumsiness * 1  4/281 (1.42%)  4 0/275 (0.00%)  0 0/274 (0.00%)  0
Nervous system disorders       
somnolence * 1  27/281 (9.61%)  27 38/275 (13.82%)  38 20/274 (7.30%)  20
headache * 2  12/281 (4.27%)  12 13/275 (4.73%)  13 10/274 (3.65%)  10
dizziness * 2  11/281 (3.91%)  11 11/275 (4.00%)  11 4/274 (1.46%)  4
insomnia * 1  3/281 (1.07%)  3 3/275 (1.09%)  3 3/274 (1.09%)  3
Lasegues Test Positive * 1  2/281 (0.71%)  2 3/275 (1.09%)  3 0/274 (0.00%)  0
pain in extremity * 1  3/281 (1.07%)  3 0/275 (0.00%)  0 1/274 (0.36%)  1
Psychiatric disorders       
anxiety * 1  3/281 (1.07%)  3 1/275 (0.36%)  1 1/274 (0.36%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
2
Term from vocabulary, MedDRA (10.0)
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, DO Sr Dir Medical Scientific Affairs
Organization: Meda Pharma US
Phone: 732 564 2347
EMail: david.ginsberg@meda.us
Layout table for additonal information
Responsible Party: Meda Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00671879     History of Changes
Other Study ID Numbers: MP511
First Submitted: May 1, 2008
First Posted: May 5, 2008
Results First Submitted: July 13, 2011
Results First Posted: November 21, 2012
Last Update Posted: November 21, 2012