A Study to Evaluate Two Formulations of Carisoprodol in Subjects With Musculoskeletal Spasm of the Lower Back
- Registration Number
- NCT00671502
- Lead Sponsor
- Meda Pharmaceuticals
- Brief Summary
The purpose of this study is to determine if two sustained released formulations of carisoprodol are more effective than placebo.
- Detailed Description
Methodology:
This was 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 consisted of a baseline screening (Study Day 1), during which subjects were evaluated for inclusion/exclusion criteria, and a 7-day double-blind treatment period (Study Day 1 through Study Day 7). Subjects were randomly assigned to be dosed twice daily with one of the following double-blind treatments: sustained release(SR) carisoprodol 500-mg tablets,sustained release (SR) carisoprodol 700-mg tablets, or placebo.
Subjects were evaluated in the clinic on Study Days 1, 3 and 7. Subjects who remained symptomatic on Study Day 7 were allowed to continue in the study for a 7-day, double-blind extension period at the discretion of the Investigator. Subjects were contacted by telephone for a safety follow-up 7 days after the last dose of study medication.
A pharmacokinetic (PK) substudy was conducted at selected sites. These sites obtained blood samples for PK analysis at the end of the 7-day treatment period and the 14-day treatment period, if applicable.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 840
- Onset of pain is within 3 days of first visit
- Subject rating of pain must be 40 mm or greater on visual analog scale( VAS)
- Ability to discontinue all analgesics, non steroidal anti inflammatory drug (NSAIDs), and other muscle relaxants
- Willingness to provide written informed consent
- Must be in generally good health
- 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 basal metabolic index(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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Carisoprodol 500mg Carisoprodol SR sustained release(SR) tablet Carisoprodol 700mg Carisoprodol SR tablet sustained release (SR) Placebo Placebo tablet
- Primary Outcome Measures
Name Time Method Subject Rating of Pain on a 100-point Visual Analog Scale (VAS) up to 14 days the scale used was from 0 to 100 mm. 0 equaled no pain and 100 equaled maximum pain.participants measure their pain before treatment and during treatment at each visit
- Secondary Outcome Measures
Name Time Method Subject Functional Assessment Based on the Roland-Morris Disability Questionnaire (RMDQ) up to 14 days Adverse Event Assessment up to 21 days the number of adverse events reported during the course of the study as reported by the participants
Trial Locations
- Locations (68)
Sunrise Medical Research #501
🇺🇸Plantation, Florida, United States
Perimeter Institute for Clinical Research, Inc.
🇺🇸Atlanta, Georgia, United States
Palm Beach Research Center
🇺🇸West Palm Beach, Florida, United States
Partners in Primary Care
🇺🇸Voorhees, New Jersey, United States
Well Pharma Medical Research Corporation
🇺🇸Miami, Florida, United States
International Research Associates, LLC
🇺🇸Miami, Florida, United States
Tukoi Clinical Research
🇺🇸Miami, Florida, United States
West Houston Clinical Research
🇺🇸Houston, Texas, United States
InVisions Consultants, LLC
🇺🇸San Antonio, Texas, United States
Harris & Associates, P.C.
🇺🇸Detroit, Michigan, United States
MedSearch, LLC
🇺🇸Birmingham, Alabama, United States
Anasazi Internal Medicine PC
🇺🇸Phoenix, Arizona, United States
Fanno Creek Clinic, LLC
🇺🇸Portland, Oregon, United States
Vaughn H. Mancha, Jr., PC Family Practice
🇺🇸Montgomery, Alabama, United States
OrthoArkansas
🇺🇸Little Rock, Arkansas, United States
Clinical Research of South Florida
🇺🇸Coral Gables, Florida, United States
Valley Medical Center
🇺🇸Flint, Michigan, United States
Trinity Health and Wellness
🇺🇸Roseville, California, United States
Quality Care Medical Center, Inc.
🇺🇸Vista, California, United States
South Florida Clinical Research Center
🇺🇸Hollywood, Florida, United States
FPA Clinical Research
🇺🇸Kissimmee, Florida, United States
San Diego Sports Medicine & Family Health Center
🇺🇸San Diego, California, United States
Heritage Physician Group
🇺🇸Hot Springs, Arkansas, United States
Quality of Life Medical Center, LLC
🇺🇸Hawaiian Gardens, California, United States
Genesis Research International
🇺🇸Longwood, Florida, United States
Anthony Roselli, MD
🇺🇸Avon, Connecticut, United States
Sunset Medical Research
🇺🇸Sunset, Louisiana, United States
Clinical Pharmacology Study Group
🇺🇸Worcester, Massachusetts, United States
Family Practice Center of Wadsworth, Inc.
🇺🇸Wadsworth, Ohio, United States
KMED Research
🇺🇸Clair Shores, Michigan, United States
Westside Family Medical Center, P.C.
🇺🇸Kalamazoo, Michigan, United States
Best Clinical Research - PA
🇺🇸Philadelphia, Pennsylvania, United States
South Jersey Medical Associations, PA
🇺🇸Blackwood, New Jersey, United States
Arcuri Clinical Research
🇺🇸Philadelphia, Pennsylvania, United States
Arlington Family Health Pavilion
🇺🇸Arlington, Texas, United States
Clinical Research Source Inc.
🇺🇸Perrysburg, Ohio, United States
ACRC Trials
🇺🇸Addison, Texas, United States
Care Center of Family Practice & Pediatrics of Hamilton
🇺🇸Hamilton, New Jersey, United States
Partners in Clinical Research
🇺🇸Cumberland, Rhode Island, United States
Oakwell Clinical Research
🇺🇸San Antonio, Texas, United States
North Texas Family Medicine
🇺🇸Plano, Texas, United States
Health Research of Hampton Roads, Inc.
🇺🇸Newport News, Virginia, United States
Liberty Research Center
🇺🇸Tacoma, Washington, United States
Sun Research Institute
🇺🇸San Antonio, Texas, United States
Unlimited Research
🇺🇸San Antonio, Texas, United States
University Clinical Research, Inc.
🇺🇸Pembroke Pines, Florida, United States
Medical Research Initiatives
🇺🇸Richmond, Virginia, United States
Northern Pines Health Center
🇺🇸Buckley, Michigan, United States
Metrolina Medical Research
🇺🇸Charlotte, North Carolina, United States
Integrated Medical Research
🇺🇸Ashland, Oregon, United States
Genesis Clinical Research Corporation
🇺🇸Huntsville, Alabama, United States
Southeastern Integrated Medical, PL dba Florida Medical Research Institute
🇺🇸Gainesville, Florida, United States
Family Practice Clinic
🇺🇸North Little Rock, Arkansas, United States
Renstar Medical Research
🇺🇸Ocala, Florida, United States
Comprehensive Clinical Research
🇺🇸Berlin, New Jersey, United States
Albuquerque Clinical Trials, Inc.
🇺🇸Albuquerque, New Mexico, United States
Williamette Valley Clinical Studies
🇺🇸Eugene, Oregon, United States
Central TX Clinical Research
🇺🇸Austin, Texas, United States
Robert S. Eagerton Jr., MD Family Practice
🇺🇸Manning, South Carolina, United States
Omega Medical Research
🇺🇸Warwick, Rhode Island, United States
Evergreen Clinical Research, LLC
🇺🇸Bellaire, Texas, United States
Holston Medical Group, P.C.
🇺🇸Bristol, Tennessee, United States
Mid-Cities Family Care
🇺🇸Bedford, Texas, United States
Prime Care Medical Group
🇺🇸Houston, Texas, United States
North Hills Family Practice
🇺🇸North Richland Hills, Texas, United States
Deer Park Family Clinic, P.A.
🇺🇸Deer Park, Texas, United States
Southwest Florida Clinical Research Center
🇺🇸Tampa, Florida, United States
Kansas City University of Medicine and BioSciences Dybedal Building
🇺🇸Kansas City, Missouri, United States