NCT00671879

Study to Evaluate Two Formulations of Carisoprodol in Subjects With Musculoskeletal Spasm of the Lower Back

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 830 (actual)
• Sponsor: Meda Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if two sustained released formulations of carisoprodol are more effective than placebo.

Detailed description

Methodology: This will be 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 consists of a baseline screening (Study Day 1), during which subjects will be evaluated for inclusion/exclusion criteria, and a 7-day double-blind treatment period (Study Day 1 through Study Day 7). Subjects will be randomly assigned to be dosed twice daily with one of the following double-blind treatments: SR carisoprodol 500-mg tablets, SR carisoprodol 700-mg tablets, or placebo. Subjects will be evaluated in the clinic on Study Days 1, 3 and 7. Subjects who remain symptomatic on Study Day 7 will be allowed to continue in the study for a 7-day, double-blind extension period at the discretion of the Investigator. Subjects will be contacted by telephone for a safety follow-up 7 days after the last dose of study medication. A pharmacokinetic (PK) substudy will be conducted at selected sites. These sites will obtain blood samples for PK analysis at the end of the 7-day treatment period and the 14-day treatment period, if applicable.

Conditions

• Lower Back Pain

Interventions

Type	Name	Description
DRUG	Carisoprodol SR 700 mg	700 mg twice daily tablet
DRUG	Carisoprodol SR 500 mg	carisoprodol SR 500 mg tablet
DRUG	Placebo	placebo tablet

Timeline

• Start date: 2008-04-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2008-05-05
• Last updated: 2012-11-21
• Results posted: 2012-11-21

Locations

73 sites across 1 country: United States