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

Completed · Phase 3 · Has a placebo group

Conditions studied: Lower Back Pain

In brief

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

Key facts

Study ID

NCT00671879

Run by

Meda Pharmaceuticals

People needed

830

Starts

2008-04-01

Expected to finish

2009-03-01

Last updated by the study team

2012-11-21

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Onset of pain is within 3 days of first visit
• 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

You may not qualify if…

• Presence of sciatic pain
• 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

Where it is running

• 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
• Brookwood Internists, P.C. — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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