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

Condition(s) targeted: Lower Back Pain

Intervention: Carisoprodol SR 700 mg (Drug); Carisoprodol SR 500 mg (Drug); Placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Meda Pharmaceuticals

Official(s) and/or principal investigator(s):
Lewis M. Fredane, MD, Study Director, Affiliation: Meda Pharmaceuticals

Overall contact:
Carrie L. D'Andrea, MS, Phone: 732-564-2538

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

Official title: 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

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Subject rating of pain on a 100-point visual analog scale

Secondary outcome:

Subject functional assessment based on the Roland-Morris Disability Questionnaire (RMDQ)

Adverse events assessment

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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 pulposis,

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

Carrie L. D'Andrea, MS, Phone: 732-564-2538

Gulf Shores General Practice Center, Gulf Shores, Alabama 36547, United States; Recruiting

Brookwood Internists, P.C., Birmingham, Alabama 35209, United States; Recruiting

Vaugh H Mancha Jr., PC Family Practice, Montgomery, Alabama 36117, United States; Recruiting

Simon Williamson Clinic, PC, Hueytown, Alabama 35023, United States; Recruiting

Fiel Family and Sports Medicine, Tempe, Arizona 85283, United States; Recruiting

NextCare Institute for Clinical Research, Phoenix, Arizona 85016, United States; Recruiting

HOPE Research Institute, Phoenix, Arizona 85050, United States; Recruiting

Lynn Institute of the Ozarks, Little Rock, Arkansas 72205, United States; Recruiting

Crest Clinical Trials, Inc., Santa Ana, California 92701, United States; Recruiting

ICT - Beverly Hills, Beverly Hills, California 90211, United States; Recruiting

San Diego Managed Care Group, San Diego, California 92128, United States; Recruiting

Newport Beach Clinical Research Associates, Inc., Newport Beach, California 92660, United States; Recruiting

Chrishard Medical Group, Inglewood, California 90301, United States; Recruiting

Lovelace Scientific Resources, Inc., Burbank, California 91506, United States; Recruiting

Santa Barbara Clinical Research Inc., Santa Barbara, California 93108, United States; Recruiting
Phone: 805-455-3819

Impact Clinical Trials and Powerplay, Los Angeles, California 90036, United States; Recruiting

Quality of life Medical, LLC, Anaheim, California 92801, United States; Recruiting

Horizons Clinical Research Center, LLC, Denver, Colorado 80220, United States; Recruiting

Clinicos, LLC, Colorado Springs, Colorado 80904, United States; Recruiting
Phone: 719-633-1467

Florida Research Network, LLC, Gainesville, Florida 32605, United States; Recruiting

Tampa Bay Medical Research, Clearwater, Florida 33761, United States; Recruiting

Oslar Medical, Inc./ Osler Clinical Research, Melbourne, Florida 32901, United States; Recruiting

Andres Patron, DO, PA, Pembroke Pines, Florida 33026, United States; Recruiting

Wilker/Powers Center for Clinical Studies, St. Cloud, Florida 34769, United States; Recruiting

Orlando Rangel, M.D., P.A., Tampa, Florida 33607, United States; Recruiting

West Wind'r Research & Development, LLC, Tampa, Florida 33607, United States; Recruiting

Jay Care Medical Center, Lakeland, Florida 33805, United States; Recruiting

Orthopaedic Assoc. of S. Broward, P.A., Hollywood, Florida 33021, United States; Recruiting

Atlantic Institute of Clinical Research, Daytona Beach, Florida 32114, United States; Recruiting

Innovative Research of West FL, Inc., Largo, Florida 33770, United States; Recruiting

FPA Clinical Research, Kissimmee, Florida 34741, United States; Recruiting

Homestead Clinical Research, Naranja, Florida 33032, United States; Recruiting

Palm Beach Research center, West Palm Beach, Florida 33409, United States; Recruiting

Best Clinical Research, Decatur, Georgia 30034, United States; Recruiting

PMI Health Research Group, Atlanta, Georgia 30312, United States; Recruiting

Perimeter Institute for Clinical Research, Inc., Atlanta, Georgia 30338, United States; Recruiting

Dupage Family Medicine, Naperville, Illinois 60564, United States; Recruiting

Heartland Research Associates, LLC, Wichita, Kansas 67205, United States; Recruiting

Central Kentucky Research Associates, Inc., Lexington, Kentucky 40509, United States; Recruiting

Bluegrass Orthopaedics & Hand Care Research, Lexington, Kentucky 40509, United States; Recruiting

Highland Clinic, APMC, Shreveport, Louisiana 71105, United States; Recruiting

Clinical Research Institute, New Orleans, Louisiana 70128, United States; Recruiting

Waterford Medical Associates, Waterford, Michigan 48328, United States; Recruiting

CRC of Jackson, Jackson, Mississippi 39202, United States; Not yet recruiting

Dr. Meera Dewan PC, Omaha, Nebraska 68144, United States; Recruiting

Quality Clinical Research, Inc., Omaha, Nebraska 68114, United States; Recruiting

ICT - Las Vegas, Las Vegas, Nevada 89106, United States; Recruiting

Association of International Professionals, Las Vegas, Nevada 89101, United States; Recruiting

Immedicenter, Bloomfield, New Jersey 07003, United States; Recruiting

Land Clinical Studies, West Caldwell, New Jersey 07006, United States; Recruiting

Research Across America, New York, New York 10022, United States; Recruiting

Odyssey Research, Fargo, North Dakota 58104, United States; Recruiting

Parsons Avenue Medical Clinic, columbus, Ohio 43207, United States; Recruiting

Dayton Clinical Research, Dayton, Ohio 45406, United States; Recruiting

Hillcrest Clinical Research, Oklahoma City, Oklahoma 73119, United States; Recruiting

Harleysville Medical Associates, Harleysville, Pennsylvania 19438, United States; Recruiting

Warminster Medical Association, Warminster, Pennsylvania 18974, United States; Recruiting
Phone: 215-674-2440

DeGarmo Institute of Medical Research, Greer, South Carolina 29651, United States; Recruiting

Palmetto Family Medicine Center, Pelzer, South Carolina 29669, United States; Recruiting

Holston Medical Group, P.C., Kingsport, Tennessee 37660, United States; Recruiting

Research Across America, Dallas, Texas 75234, United States; Recruiting

GSA Research, San Antonio, Texas 78213, United States; Recruiting

DiscoveResearch, Inc., Bryan, Texas 77802, United States; Recruiting

Central Texas Health Research, New Braunfels, Texas 78130, United States; Recruiting

F. Adam Kawley, MD PA, Houston, Texas 77024, United States; Recruiting

Medical Clinic of North Texas, Arlington, Texas 76012, United States; Recruiting

Clinical Health Research, LLC, Sugar Land, Texas 77479, United States; Recruiting

Sylvana Research Associates, San Antonio, Texas 78229, United States; Recruiting

Texas Family Care Clinical Research, Colleyville, Texas 76034, United States; Recruiting

Georgetown Medical Clinic, Georgetown, Texas 78626, United States; Recruiting
Phone: 512-930-4593

Central Texas Clinical Research, Austin, Texas 78705, United States; Recruiting

Sun Research Institute, San Antonio, Texas 78215, United States; Recruiting

Holston Medical Group, P.C., Weber City, Virginia 24290, United States; Recruiting

Starting date: April 2008
Ending date: March 2009
Last updated: January 21, 2009