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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
The purpose of this study is to determine if two sustained released formulations of carisoprodol are more effective than placebo.
Details
| Lead sponsor | Meda Pharmaceuticals |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 840 |
| Start date | 2008-04 |
| Completion | 2009-02 |
Conditions
- Lower Back Pain
Interventions
- Carisoprodol SR
- Carisoprodol SR
- Placebo
Primary outcomes
- Subject Rating of Pain on a 100-point Visual Analog Scale (VAS) — up to 14 days
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
Countries
United States