A Study to Evaluate Two Formulations of Carisoprodol in Subjects With Musculoskeletal Spasm of the Lower Back
The purpose of this study is to determine if two sustained released formulations of carisoprodol are more effective than placebo.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Randomized, Double-Blind, Double-Dummy Trial of Two Sustained Release Formulations of Carisoprodol Compared to Placebo in Subjects With Acute, Painful, Musculoskeletal Spasm of the Lower Back|
- Subject Rating of Pain on a 100-point Visual Analog Scale (VAS) [ Time Frame: up to 14 days ] [ Designated as safety issue: No ]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
- Subject Functional Assessment Based on the Roland-Morris Disability Questionnaire (RMDQ) [ Time Frame: up to 14 days ] [ Designated as safety issue: No ]
- Adverse Event Assessment [ Time Frame: up to 21 days ] [ Designated as safety issue: Yes ]the number of adverse events reported during the course of the study as reported by the participants
|Study Start Date:||April 2008|
|Study Completion Date:||February 2009|
|Primary Completion Date:||February 2009 (Final data collection date for primary outcome measure)|
Experimental: Carisoprodol 700mg
tablet sustained release (SR)
Drug: Carisoprodol SR
700 mg twice daily
Other Name: sustained release(SR)
Experimental: Carisoprodol 500mg
sustained release(SR) tablet
Drug: Carisoprodol SR
500 mg twice daily
Other Name: sustained release(SR) tablet
Placebo Comparator: Placebo
Other Name: no other name
This was a randomized, double-blind, double-dummy, placebo-controlled, parallel-group study in subjects 18-70 years of age with acute, painful, muscle spasm of the lower back. The study consisted of a baseline screening (Study Day 1), during which subjects were evaluated for inclusion/exclusion criteria, and a 7-day double-blind treatment period (Study Day 1 through Study Day 7). Subjects were randomly assigned to be dosed twice daily with one of the following double-blind treatments: sustained release(SR) carisoprodol 500-mg tablets,sustained release (SR) carisoprodol 700-mg tablets, or placebo.
Subjects were evaluated in the clinic on Study Days 1, 3 and 7. Subjects who remained symptomatic on Study Day 7 were allowed to continue in the study for a 7-day, double-blind extension period at the discretion of the Investigator. Subjects were contacted by telephone for a safety follow-up 7 days after the last dose of study medication.
A pharmacokinetic (PK) substudy was conducted at selected sites. These sites obtained blood samples for PK analysis at the end of the 7-day treatment period and the 14-day treatment period, if applicable.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00671502
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|Study Director:||Lewis M. Fredane, MD||Meda Pharmaceuticals|