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Sponsored by: |
Meda Pharmaceuticals |
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Information provided by: | Meda Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00671879 |
The purpose of this study is to determine if two sustained released formulations of carisoprodol are more effective than placebo.
Condition | Intervention | Phase |
---|---|---|
Lower Back Pain |
Drug: Carisoprodol SR 700 mg Drug: Carisoprodol SR 500 mg Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 840 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Carisprodol SR 700 mg: Experimental
Carisoprodol 700 mg twice daily
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Drug: Carisoprodol SR 700 mg
700 mg twice daily
|
Carisoprodol SR 500mg: Experimental
Carisoprodol SR 500 mg twice daily
|
Drug: Carisoprodol SR 500 mg
carisoprodol SR 500 mg
|
Placebo: Placebo Comparator
Placebo
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Drug: Placebo
placebo
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Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Carrie L. D'Andrea, MS | 732-564-2538 |
Study Director: | Lewis M. Fredane, MD | Meda Pharmaceuticals |
Responsible Party: | Meda Pharmaceuticals ( Harry Sacks, MD Vice President, Medical and Scientific Affairs ) |
Study ID Numbers: | MP511 |
Study First Received: | May 1, 2008 |
Last Updated: | December 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00671879 |
Health Authority: | United States: Food and Drug Administration |
Spasm Carisoprodol Signs and Symptoms Neurologic Manifestations |
Low Back Pain Pain Back Pain |
Therapeutic Uses Muscle Relaxants, Central Physiological Effects of Drugs Nervous System Diseases |
Neuromuscular Agents Peripheral Nervous System Agents Central Nervous System Agents Pharmacologic Actions |