A Study to Evaluate Two Formulations of Carisoprodol in Subjects With Musculoskeletal Spasm of the Lower Back
NCT ID: NCT00671502
Last Updated: 2011-11-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
840 participants
INTERVENTIONAL
2008-04-30
2009-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Carisoprodol 700mg
tablet sustained release (SR)
Carisoprodol SR
700 mg twice daily
Carisoprodol 500mg
sustained release(SR) tablet
Carisoprodol SR
500 mg twice daily
Placebo
tablet
Placebo
Placebo tablet
Interventions
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Carisoprodol SR
700 mg twice daily
Carisoprodol SR
500 mg twice daily
Placebo
Placebo tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject rating of pain must be 40 mm or greater on visual analog scale( VAS)
* Ability to discontinue all analgesics, non steroidal anti inflammatory drug (NSAIDs), and other muscle relaxants
* Willingness to provide written informed consent
* Must be in generally good health
Exclusion Criteria
* History of clinically significant spine pathology such as herniated nucleas pulposis, spondylolisthesis, spinal stenosis
* Presence of underlying chronic back pain
* Neurological signs and symptoms such as numbness, tingling, foot drop, parethesia, unexplained constipation, urinary retention or urinary incontinence
* Myocardial infaction within one year of study
* Cancer not in remission or in remission less than one year
* HIV or other immunodeficiency syndromes
* History of osteoporosis or at high risk for vetebral fracture
* Underlying rheumatologic disease such as rheumatoid arthritis, ankylosing spondylitis, etc.
* Presence of active influenze or other viral syndromes
* Morbid obesity basal metabolic index(BMI \>39)
* Evidence of infection, such as low grade fever or neutrophilia
* Existence of any medical/surgical condition that could interfere with the evaluation of the study medication
* Known history of alcohol or drug abuse
* Injury involving high potential for litigation, including worker's compensation or automobile accidents
* Pregnancy or breast feeding
* Women of child-bearing potential not abstinent or not practicing a medically acceptable method of contraception
* Vertebral body or spinous process, percussive tenderness on physical exam
* Any abnormalities in the following tests of both lower extremities: ankle dorsiflexion strength, great toe dorsiflexion strength, absent or hypereflexic Achilles or patellar tendor reflexes, abnormal sensory exam in the medial, dorsal or lateral aspect of the foot and positive straight leg raise test
* Urgent medical conditions on comprehensive exam that might indicate a more serious condition should be treated urgently
18 Years
70 Years
ALL
No
Sponsors
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Meda Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Lewis M. Fredane, MD
Role: STUDY_DIRECTOR
Meda Pharmaceuticals
Locations
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MedSearch, LLC
Birmingham, Alabama, United States
Genesis Clinical Research Corporation
Huntsville, Alabama, United States
Vaughn H. Mancha, Jr., PC Family Practice
Montgomery, Alabama, United States
Anasazi Internal Medicine PC
Phoenix, Arizona, United States
Heritage Physician Group
Hot Springs, Arkansas, United States
OrthoArkansas
Little Rock, Arkansas, United States
Family Practice Clinic
North Little Rock, Arkansas, United States
Quality of Life Medical Center, LLC
Hawaiian Gardens, California, United States
Trinity Health and Wellness
Roseville, California, United States
San Diego Sports Medicine & Family Health Center
San Diego, California, United States
Quality Care Medical Center, Inc.
Vista, California, United States
Anthony Roselli, MD
Avon, Connecticut, United States
Clinical Research of South Florida
Coral Gables, Florida, United States
Southeastern Integrated Medical, PL dba Florida Medical Research Institute
Gainesville, Florida, United States
South Florida Clinical Research Center
Hollywood, Florida, United States
FPA Clinical Research
Kissimmee, Florida, United States
Genesis Research International
Longwood, Florida, United States
Well Pharma Medical Research Corporation
Miami, Florida, United States
International Research Associates, LLC
Miami, Florida, United States
Tukoi Clinical Research
Miami, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
University Clinical Research, Inc.
Pembroke Pines, Florida, United States
Sunrise Medical Research #501
Plantation, Florida, United States
Southwest Florida Clinical Research Center
Tampa, Florida, United States
Palm Beach Research Center
West Palm Beach, Florida, United States
Perimeter Institute for Clinical Research, Inc.
Atlanta, Georgia, United States
Sunset Medical Research
Sunset, Louisiana, United States
Clinical Pharmacology Study Group
Worcester, Massachusetts, United States
Northern Pines Health Center
Buckley, Michigan, United States
KMED Research
Clair Shores, Michigan, United States
Harris & Associates, P.C.
Detroit, Michigan, United States
Valley Medical Center
Flint, Michigan, United States
Westside Family Medical Center, P.C.
Kalamazoo, Michigan, United States
Kansas City University of Medicine and BioSciences Dybedal Building
Kansas City, Missouri, United States
Comprehensive Clinical Research
Berlin, New Jersey, United States
South Jersey Medical Associations, PA
Blackwood, New Jersey, United States
Care Center of Family Practice & Pediatrics of Hamilton
Hamilton, New Jersey, United States
Partners in Primary Care
Voorhees Township, New Jersey, United States
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, United States
Metrolina Medical Research
Charlotte, North Carolina, United States
Clinical Research Source Inc.
Perrysburg, Ohio, United States
Family Practice Center of Wadsworth, Inc.
Wadsworth, Ohio, United States
Integrated Medical Research
Ashland, Oregon, United States
Williamette Valley Clinical Studies
Eugene, Oregon, United States
Fanno Creek Clinic, LLC
Portland, Oregon, United States
Best Clinical Research - PA
Philadelphia, Pennsylvania, United States
Arcuri Clinical Research
Philadelphia, Pennsylvania, United States
Partners in Clinical Research
Cumberland, Rhode Island, United States
Omega Medical Research
Warwick, Rhode Island, United States
Robert S. Eagerton Jr., MD Family Practice
Manning, South Carolina, United States
Holston Medical Group, P.C.
Bristol, Tennessee, United States
ACRC Trials
Addison, Texas, United States
Arlington Family Health Pavilion
Arlington, Texas, United States
Central TX Clinical Research
Austin, Texas, United States
Mid-Cities Family Care
Bedford, Texas, United States
Evergreen Clinical Research, LLC
Bellaire, Texas, United States
Deer Park Family Clinic, P.A.
Deer Park, Texas, United States
Prime Care Medical Group
Houston, Texas, United States
West Houston Clinical Research
Houston, Texas, United States
North Hills Family Practice
North Richland Hills, Texas, United States
North Texas Family Medicine
Plano, Texas, United States
Sun Research Institute
San Antonio, Texas, United States
Unlimited Research
San Antonio, Texas, United States
InVisions Consultants, LLC
San Antonio, Texas, United States
Oakwell Clinical Research
San Antonio, Texas, United States
Health Research of Hampton Roads, Inc.
Newport News, Virginia, United States
Medical Research Initiatives
Richmond, Virginia, United States
Liberty Research Center
Tacoma, Washington, United States
Countries
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Other Identifiers
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MP510
Identifier Type: -
Identifier Source: org_study_id