At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 840 enrolled
Drug / intervention
Carisoprodol SR +2 moredrug
Likely dose
Carisoprodol SR 700 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Carisoprodol SR and Placebo for Lower Back Pain. Completed, enrolled 840 participants across 68 sites.
Detailed Summary
The purpose of this study is to determine if two sustained released formulations of carisoprodol are more effective than placebo.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLower Back Pain
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2008
First PostedMay 2008
Primary CompletionFeb 2009
TodayJul 2026
First PostedMay 5, 2008
Enrollment StartApr 1, 2008
Primary CompletionFeb 1, 2009
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 18.2 years ago
Interventions
Carisoprodol SRdrug
700 mg twice daily
Carisoprodol SRdrug
500 mg twice daily
Placebodrug
Placebo tablet