At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 830 enrolled
Drug / intervention
Carisoprodol SR 700 mg +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 700 mg, Carisoprodol SR 500 mg, and 1 other intervention for Lower Back Pain. Completed, enrolled 830 participants across 73 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 CompletionMar 2009
TodayJul 2026
First PostedMay 5, 2008
Enrollment StartApr 1, 2008
Primary CompletionMar 1, 2009
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 18.2 years ago
Interventions
Carisoprodol SR 700 mgdrug
700 mg twice daily tablet
Carisoprodol SR 500 mgdrug
carisoprodol SR 500 mg tablet
Placebodrug
placebo tablet