A Study to Evaluate Two Formulations of Carisoprodol in Subjects With Musculoskeletal Spasm of the Lower Back
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ClinicalTrials.gov Identifier: NCT00671502 |
Recruitment Status :
Completed
First Posted : May 5, 2008
Results First Posted : November 9, 2011
Last Update Posted : November 9, 2011
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Tracking Information | ||||
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First Submitted Date ICMJE | May 1, 2008 | |||
First Posted Date ICMJE | May 5, 2008 | |||
Results First Submitted Date ICMJE | June 28, 2011 | |||
Results First Posted Date ICMJE | November 9, 2011 | |||
Last Update Posted Date | November 9, 2011 | |||
Study Start Date ICMJE | April 2008 | |||
Actual Primary Completion Date | February 2009 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Subject Rating of Pain on a 100-point Visual Analog Scale (VAS) [ Time Frame: up to 14 days ] the scale used was from 0 to 100 mm. 0 equaled no pain and 100 equaled maximum pain.participants measure their pain before treatment and during treatment at each visit
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Original Primary Outcome Measures ICMJE |
Subject Rating of Pain on a 100-point Visual Analog Scale (VAS) [ Time Frame: up to 14 days ] | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | A Study to Evaluate Two Formulations of Carisoprodol in Subjects With Musculoskeletal Spasm of the Lower Back | |||
Official Title ICMJE | 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 | |||
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 was 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 consisted of a baseline screening (Study Day 1), during which subjects were evaluated for inclusion/exclusion criteria, and a 7-day double-blind treatment period (Study Day 1 through Study Day 7). Subjects were randomly assigned to be dosed twice daily with one of the following double-blind treatments: sustained release(SR) carisoprodol 500-mg tablets,sustained release (SR) carisoprodol 700-mg tablets, or placebo. Subjects were evaluated in the clinic on Study Days 1, 3 and 7. Subjects who remained symptomatic on Study Day 7 were allowed to continue in the study for a 7-day, double-blind extension period at the discretion of the Investigator. Subjects were contacted by telephone for a safety follow-up 7 days after the last dose of study medication. A pharmacokinetic (PK) substudy was conducted at selected sites. These sites obtained blood samples for PK analysis at the end of the 7-day treatment period and the 14-day treatment period, if applicable. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Lower Back Pain | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
840 | |||
Original Estimated Enrollment ICMJE |
750 | |||
Actual Study Completion Date ICMJE | February 2009 | |||
Actual Primary Completion Date | February 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00671502 | |||
Other Study ID Numbers ICMJE | MP510 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Meda Pharmaceuticals | |||
Study Sponsor ICMJE | Meda Pharmaceuticals | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Meda Pharmaceuticals | |||
Verification Date | October 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |