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

Information source: Meda Pharmaceuticals
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lower Back Pain

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

Phase: Phase 3

Status: Completed

Sponsored by: Meda Pharmaceuticals

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

Summary

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

Clinical Details

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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Subject Rated Change Relief From Starting Backache of Pain on a 100-point Visual Analog Scale

Secondary outcome: Subject Functional Assessment Based on the Roland-Morris Disability Questionnaire (RMDQ)

Detailed description: Methodology: 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.

Eligibility

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 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

Locations and Contacts

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

Additional Information

Starting date: April 2008
Last updated: October 22, 2012

Page last updated: August 20, 2015

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