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

NCT00671879 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 830

Last updated 2012-11-21

Study results available
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Summary

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

Conditions

  • Lower Back Pain

Interventions

DRUG

Carisoprodol SR 700 mg

700 mg twice daily tablet

DRUG

Carisoprodol SR 500 mg

carisoprodol SR 500 mg tablet

DRUG

Placebo

placebo tablet

Sponsors & Collaborators

  • Meda Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Lewis M. Fredane, MD · Meda Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00671879 on ClinicalTrials.gov