Study to Evaluate Two Formulations of Carisoprodol in Subjects With Musculoskeletal Spasm of the Lower Back
NCT ID: NCT00671879
Last Updated: 2012-11-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
830 participants
INTERVENTIONAL
2008-04-30
2009-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Carisprodol SR 700 mg
Carisoprodol 700 mg twice daily
Carisoprodol SR 700 mg
700 mg twice daily tablet
Carisoprodol SR 500mg
Carisoprodol SR 500 mg twice daily
Carisoprodol SR 500 mg
carisoprodol SR 500 mg tablet
Placebo
Placebo
Placebo
placebo tablet
Interventions
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Carisoprodol SR 700 mg
700 mg twice daily tablet
Carisoprodol SR 500 mg
carisoprodol SR 500 mg tablet
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 VAS
* Ability to discontinue all analgesics, 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 nucleus pulpous, spondylolisthesis, spinal stenosis
* Presence of underlying chronic back pain
* Neurological signs and symptoms such as numbness, tingling, foot drop, paresthesia, unexplained constipation, urinary retention or urinary incontinence
* Myocardial infarction 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 vertebral fracture
* Underlying rheumatologic disease such as rheumatoid arthritis, ankylosing spondylitis, etc.
* Presence of active influenza or other viral syndromes
* Morbid obesity (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 hyperreflexic 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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Brookwood Internists, P.C.
Birmingham, Alabama, United States
Gulf Shores General Practice Center
Gulf Shores, Alabama, United States
Simon Williamson Clinic, PC
Hueytown, Alabama, United States
Vaugh H Mancha Jr., PC Family Practice
Montgomery, Alabama, United States
NextCare Institute for Clinical Research
Phoenix, Arizona, United States
HOPE Research Institute
Phoenix, Arizona, United States
Fiel Family and Sports Medicine
Tempe, Arizona, United States
Lynn Institute of the Ozarks
Little Rock, Arkansas, United States
Quality of life Medical, LLC
Anaheim, California, United States
ICT - Beverly Hills
Beverly Hills, California, United States
Lovelace Scientific Resources, Inc.
Burbank, California, United States
Chrishard Medical Group
Inglewood, California, United States
Impact Clinical Trials and Powerplay
Los Angeles, California, United States
Newport Beach Clinical Research Associates, Inc.
Newport Beach, California, United States
San Diego Managed Care Group
San Diego, California, United States
Crest Clinical Trials, Inc.
Santa Ana, California, United States
Santa Barbara Clinical Research Inc.
Santa Barbara, California, United States
Clinicos, LLC
Colorado Springs, Colorado, United States
Horizons Clinical Research Center, LLC
Denver, Colorado, United States
Tampa Bay Medical Research
Clearwater, Florida, United States
Atlantic Institute of Clinical Research
Daytona Beach, Florida, United States
Florida Research Network, LLC
Gainesville, Florida, United States
Orthopaedic Assoc. of S. Broward, P.A.
Hollywood, Florida, United States
FPA Clinical Research
Kissimmee, Florida, United States
Jay Care Medical Center
Lakeland, Florida, United States
Innovative Research of West FL, Inc.
Largo, Florida, United States
Oslar Medical, Inc./ Osler Clinical Research
Melbourne, Florida, United States
Homestead Clinical Research
Naranja, Florida, United States
Andres Patron, DO, PA
Pembroke Pines, Florida, United States
Wilker/Powers Center for Clinical Studies
Saint Cloud, Florida, United States
Orlando Rangel, M.D., P.A.
Tampa, Florida, United States
West Wind'r Research & Development, LLC
Tampa, Florida, United States
Palm Beach Research center
West Palm Beach, Florida, United States
PMI Health Research Group
Atlanta, Georgia, United States
Perimeter Institute for Clinical Research, Inc.
Atlanta, Georgia, United States
Best Clinical Research
Decatur, Georgia, United States
Dupage Family Medicine
Naperville, Illinois, United States
Heartland Research Associates, LLC
Wichita, Kansas, United States
Bluegrass Orthopaedics & Hand Care Research
Lexington, Kentucky, United States
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, United States
Clinical Research Institute
New Orleans, Louisiana, United States
Highland Clinic, APMC
Shreveport, Louisiana, United States
Waterford Medical Associates
Waterford, Michigan, United States
CRC of Jackson
Jackson, Mississippi, United States
Quality Clinical Research, Inc.
Omaha, Nebraska, United States
Dr. Meera Dewan PC
Omaha, Nebraska, United States
Association of International Professionals
Las Vegas, Nevada, United States
ICT - Las Vegas
Las Vegas, Nevada, United States
Immedicenter
Bloomfield, New Jersey, United States
Land Clinical Studies
West Caldwell, New Jersey, United States
Research Across America
New York, New York, United States
Odyssey Research
Fargo, North Dakota, United States
Parsons Avenue Medical Clinic
Columbus, Ohio, United States
Dayton Clinical Research
Dayton, Ohio, United States
Hillcrest Clinical Research
Oklahoma City, Oklahoma, United States
Harleysville Medical Associates
Harleysville, Pennsylvania, United States
Warminster Medical Association
Warminster, Pennsylvania, United States
DeGarmo Institute of Medical Research
Greer, South Carolina, United States
Palmetto Family Medicine Center
Pelzer, South Carolina, United States
Holston Medical Group, P.C.
Kingsport, Tennessee, United States
Medical Clinic of North Texas
Arlington, Texas, United States
Central Texas Clinical Research
Austin, Texas, United States
DiscoveResearch, Inc.
Bryan, Texas, United States
Texas Family Care Clinical Research
Colleyville, Texas, United States
Research Across America
Dallas, Texas, United States
Georgetown Medical Clinic
Georgetown, Texas, United States
F. Adam Kawley, MD PA
Houston, Texas, United States
Central Texas Health Research
New Braunfels, Texas, United States
GSA Research
San Antonio, Texas, United States
Sun Research Institute
San Antonio, Texas, United States
Sylvana Research Associates
San Antonio, Texas, United States
Clinical Health Research, LLC
Sugar Land, Texas, United States
Holston Medical Group, P.C.
Weber City, Virginia, United States
Countries
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Other Identifiers
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MP511
Identifier Type: -
Identifier Source: org_study_id