Conditions: Lower Back Pain
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 830
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Carisoprodol 700 mg twice daily arm 2: Carisoprodol SR 500 mg twice daily arm 3: Placebo

Interventions: intervention 1: Carisoprodol SR 700 mg intervention 2: Carisoprodol SR 500 mg intervention 3: Placebo
Intervention descriptions: intervention 1: 700 mg twice daily tablet intervention 2: carisoprodol SR 500 mg tablet intervention 3: placebo tablet

Protocol document: