The purpose of this study is to determine if two sustained released formulations of
carisoprodol are more effective than placebo.
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Brookwood Internists, P.C., Birmingham, Alabama 35209, United States
Gulf Shores General Practice Center, Gulf Shores, Alabama 36547, United States
Simon Williamson Clinic, PC, Hueytown, Alabama 35023, United States
Vaugh H Mancha Jr., PC Family Practice, Montgomery, Alabama 36117, United States
HOPE Research Institute, Phoenix, Arizona 85050, United States
NextCare Institute for Clinical Research, Phoenix, Arizona 85016, United States
Fiel Family and Sports Medicine, Tempe, Arizona 85283, United States
Lynn Institute of the Ozarks, Little Rock, Arkansas 72205, United States
Quality of life Medical, LLC, Anaheim, California 92801, United States
ICT - Beverly Hills, Beverly Hills, California 90211, United States
Lovelace Scientific Resources, Inc., Burbank, California 91506, United States
Chrishard Medical Group, Inglewood, California 90301, United States
Impact Clinical Trials and Powerplay, Los Angeles, California 90036, United States
Newport Beach Clinical Research Associates, Inc., Newport Beach, California 92660, United States
San Diego Managed Care Group, San Diego, California 92128, United States
Crest Clinical Trials, Inc., Santa Ana, California 92701, United States
Santa Barbara Clinical Research Inc., Santa Barbara, California 93108, United States
Clinicos, LLC, Colorado Springs, Colorado 80904, United States
Horizons Clinical Research Center, LLC, Denver, Colorado 80220, United States
Tampa Bay Medical Research, Clearwater, Florida 33761, United States
Atlantic Institute of Clinical Research, Daytona Beach, Florida 32114, United States
Florida Research Network, LLC, Gainesville, Florida 32605, United States
Orthopaedic Assoc. of S. Broward, P.A., Hollywood, Florida 33021, United States
FPA Clinical Research, Kissimmee, Florida 34741, United States
Jay Care Medical Center, Lakeland, Florida 33805, United States
Innovative Research of West FL, Inc., Largo, Florida 33770, United States
Oslar Medical, Inc./ Osler Clinical Research, Melbourne, Florida 32901, United States
Homestead Clinical Research, Naranja, Florida 33032, United States
Andres Patron, DO, PA, Pembroke Pines, Florida 33026, United States
Wilker/Powers Center for Clinical Studies, St. Cloud, Florida 34769, United States
Orlando Rangel, M.D., P.A., Tampa, Florida 33607, United States
West Wind'r Research & Development, LLC, Tampa, Florida 33607, United States
Palm Beach Research center, West Palm Beach, Florida 33409, United States
Perimeter Institute for Clinical Research, Inc., Atlanta, Georgia 30338, United States
PMI Health Research Group, Atlanta, Georgia 30312, United States
Best Clinical Research, Decatur, Georgia 30034, United States
Dupage Family Medicine, Naperville, Illinois 60564, United States
Heartland Research Associates, LLC, Wichita, Kansas 67205, United States
Bluegrass Orthopaedics & Hand Care Research, Lexington, Kentucky 40509, United States
Central Kentucky Research Associates, Inc., Lexington, Kentucky 40509, United States
Clinical Research Institute, New Orleans, Louisiana 70128, United States
Highland Clinic, APMC, Shreveport, Louisiana 71105, United States
Waterford Medical Associates, Waterford, Michigan 48328, United States
CRC of Jackson, Jackson, Mississippi 39202, United States
Dr. Meera Dewan PC, Omaha, Nebraska 68144, United States
Quality Clinical Research, Inc., Omaha, Nebraska 68114, United States
Association of International Professionals, Las Vegas, Nevada 89101, United States
ICT - Las Vegas, Las Vegas, Nevada 89106, United States
Immedicenter, Bloomfield, New Jersey 07003, United States
Land Clinical Studies, West Caldwell, New Jersey 07006, United States
Research Across America, New York, New York 10022, United States
Odyssey Research, Fargo, North Dakota 58104, United States
Parsons Avenue Medical Clinic, Columbus, Ohio 43207, United States
Dayton Clinical Research, Dayton, Ohio 45406, United States
Hillcrest Clinical Research, Oklahoma City, Oklahoma 73119, United States
Harleysville Medical Associates, Harleysville, Pennsylvania 19438, United States
Warminster Medical Association, Warminster, Pennsylvania 18974, United States
DeGarmo Institute of Medical Research, Greer, South Carolina 29651, United States
Palmetto Family Medicine Center, Pelzer, South Carolina 29669, United States
Holston Medical Group, P.C., Kingsport, Tennessee 37660, United States
Medical Clinic of North Texas, Arlington, Texas 76012, United States
Central Texas Clinical Research, Austin, Texas 78705, United States
DiscoveResearch, Inc., Bryan, Texas 77802, United States
Texas Family Care Clinical Research, Colleyville, Texas 76034, United States
Research Across America, Dallas, Texas 75234, United States
Georgetown Medical Clinic, Georgetown, Texas 78626, United States
F. Adam Kawley, MD PA, Houston, Texas 77024, United States
Central Texas Health Research, New Braunfels, Texas 78130, United States
GSA Research, San Antonio, Texas 78213, United States
Sun Research Institute, San Antonio, Texas 78215, United States
Sylvana Research Associates, San Antonio, Texas 78229, United States
Clinical Health Research, LLC, Sugar Land, Texas 77479, United States
Holston Medical Group, P.C., Weber City, Virginia 24290, United States