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

Condition(s) targeted: Lower Back Pain

Intervention: Carisoprodol (Drug); Carisoprodol SR (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), Active Control, Parallel Assignment, Safety/Efficacy Study

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

Secondary outcome:

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

Adverse events assessments

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 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 (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

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

MedSearch, LLC, Birmingham, Alabama 35235, United States; Recruiting

Genesis Clinical Research Corporation, Huntsville, Alabama 35802, United States; Recruiting

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

Anasazi Internal Medicine PC, Phoenix, Arizona 85032, United States; Recruiting
Phone: 602-424-0919

Family Practice Clinic, North Little Rock, Arkansas 72114, United States; Recruiting

Heritage Physician Group, Hot Springs, Arkansas 71913, United States; Recruiting

OrthoArkansas, Little Rock, Arkansas 72205, United States; Not yet recruiting

Trinity Health and Wellness, Roseville, California 95661, United States; Recruiting

San Diego Sports Medicine & Family Health Center, San Diego, California 92120, United States; Recruiting

Quality of Life Medical Center, LLC, Hawaiian Gardens, California 90716, United States; Recruiting

Quality Care Medical Center, Inc., Vista, California 92084, United States; Recruiting

Anthony Roselli, MD, Avon, Connecticut 06001, United States; Recruiting
Phone: 860-673-6146

Well Pharma Medical Research Corporation, Miami, Florida 33143, United States; Recruiting

International Research Associates, LLC, Miami, Florida 33156, United States; Recruiting

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

Tukoi Clinical Research, Miami, Florida 33180, United States; Recruiting

Southeastern Integrated Medical, PL dba Florida Medical Research Institute, Gainesville, Florida 32607, United States; Recruiting

Southwest Florida Clinical Research Center, Tampa, Florida 33609, United States; Recruiting

University Clinical Research, Inc., Pembroke Pines, Florida 33024, United States; Recruiting

Clinical Research of South Florida, Coral Gables, Florida 33134, United States; Recruiting

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

South Florida Clinical Research Center, Hollywood, Florida 33023, United States; Recruiting

Genesis Research International, Longwood, Florida 32779, United States; Recruiting

Sunrise Medical Research #501, Plantation, Florida 33324, United States; Recruiting
Phone: 954-915-9991

Renstar Medical Research, Ocala, Florida 34471, United States; Recruiting

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

Sunset Medical Research, Sunset, Louisiana 70584, United States; Recruiting

Clinical Pharmacology Study Group, Worcester, Massachusetts 01610, United States; Recruiting

Harris & Associates, P.C., Detroit, Michigan 48235, United States; Recruiting

Northern Pines Health Center, Buckley, Michigan 49620, United States; Recruiting

Westside Family Medical Center, P.C., Kalamazoo, Michigan 49009, United States; Recruiting

Valley Medical Center, Flint, Michigan 48507, United States; Recruiting

KMED Research, Clair Shores, Michigan 48081, United States; Recruiting

Kansas City University of Medicine and BioSciences Dybedal Building, Kansas City, Missouri 64106, United States; Recruiting
Phone: 816-283-2335

Partners in Primary Care, Voorhees, New Jersey 08043, United States; Recruiting

Comprehensive Clinical Research, Berlin, New Jersey 08009, United States; Recruiting

South Jersey Medical Associations, PA, Blackwood, New Jersey 08012, United States; Recruiting

Care Center of Family Practice & Pediatrics of Hamilton, Hamilton, New Jersey 08610, United States; Recruiting

Albuquerque Clinical Trials, Inc., Albuquerque, New Mexico 87102, United States; Recruiting

Metrolina Medical Research, Charlotte, North Carolina 28209, United States; Recruiting

Family Practice Center of Wadsworth, Inc., Wadsworth, Ohio 44281, United States; Recruiting

Clinical Research Source Inc., Perrysburg, Ohio 43551, United States; Recruiting

Williamette Valley Clinical Studies, Eugene, Oregon 91404, United States; Recruiting

Fanno Creek Clinic, LLC, Portland, Oregon 97219, United States; Not yet recruiting

Integrated Medical Research, Ashland, Oregon 97520, United States; Recruiting

Best Clinical Research - PA, Philadelphia, Pennsylvania 19104, United States; Not yet recruiting

Arcuri Clinical Research, Philadelphia, Pennsylvania 19142, United States; Recruiting

Omega Medical Research, Warwick, Rhode Island 02886, United States; Recruiting

Partners in Clinical Research, Cumberland, Rhode Island 02864, United States; Recruiting

Robert S. Eagerton Jr., MD Family Practice, Manning, South Carolina 29102, United States; Recruiting

Holston Medical Group, P.C., Bristol, Tennessee 37620, United States; Recruiting

Sun Research Institute, San Antonio, Texas 78205, United States; Recruiting

West Houston Clinical Research, Houston, Texas 77055, United States; Recruiting

Prime Care Medical Group, Houston, Texas 77024, United States; Recruiting

North Hills Family Practice, North Richland Hills, Texas 76180, United States; Recruiting

InVisions Consultants, LLC, San Antonio, Texas 78218, United States; Recruiting

Mid-Cities Family Care, Bedford, Texas 76021, United States; Recruiting

North Texas Family Medicine, Plano, Texas 75093, United States; Recruiting

Arlington Family Health Pavilion, Arlington, Texas 76012, United States; Recruiting

Deer Park Family Clinic, P.A., Deer Park, Texas 77536, United States; Recruiting

Unlimited Research, San Antonio, Texas 78217, United States; Recruiting

Central TX Clinical Research, Austin, Texas 78705, United States; Recruiting
Phone: 512-480-9660

Evergreen Clinical Research, LLC, Bellaire, Texas 77401, United States; Recruiting
Phone: 713-218-8700

ACRC Trials, Addison, Texas 75001, United States; Recruiting

Oakwell Clinical Research, San Antonio, Texas 78218, United States; Recruiting

Medical Research Initiatives, Richmond, Virginia 23230, United States; Recruiting

Health Research of Hampton Roads, Inc., Newport News, Virginia 23606, United States; Recruiting

Liberty Research Center, Tacoma, Washington 98405, United States; Recruiting

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