Study to Evaluate Two Formulations of Carisoprodol in Subjects With Musculoskeletal Spasm of the Lower Back
- Conditions
- Lower Back Pain
- Interventions
- Registration Number
- NCT00671879
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 830
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Carisprodol SR 700 mg Carisoprodol SR 700 mg Carisoprodol 700 mg twice daily Carisoprodol SR 500mg Carisoprodol SR 500 mg Carisoprodol SR 500 mg twice daily Placebo Placebo Placebo
- Primary Outcome Measures
Name Time Method Subject Rated Change Relief From Starting Backache of Pain on a 100-point Visual Analog Scale baseline to 14 days on a visual analog scale of 0 to 100 millimeters(mm) with 0 being no pain and 100 being maximum pain By measuring the amount of pain before and during treatment done at each visit and recording the difference in mm.During treatment scores were averaged and this average was compared to the baseline value.
- Secondary Outcome Measures
Name Time Method Subject Functional Assessment Based on the Roland-Morris Disability Questionnaire (RMDQ) baseline and day +14 Subject functional assessment based on the Roland-Morris Disability Questionnaire (RMDQ)at day 14.Subjects were asked to read a list of 24 sentences that people have used to describe themselves when they had back pain, and were asked to mark those statements that described their condition that day. The number of marked statements was added. A decrease in the number of marked statements from baseline represented improvement on the RMDQ.
Trial Locations
- Locations (71)
Lovelace Scientific Resources, Inc.
🇺🇸Burbank, California, United States
Crest Clinical Trials, Inc.
🇺🇸Santa Ana, California, United States
Orthopaedic Assoc. of S. Broward, P.A.
🇺🇸Hollywood, Florida, United States
Oslar Medical, Inc./ Osler Clinical Research
🇺🇸Melbourne, Florida, United States
Andres Patron, DO, PA
🇺🇸Pembroke Pines, Florida, United States
Perimeter Institute for Clinical Research, Inc.
🇺🇸Atlanta, Georgia, United States
Best Clinical Research
🇺🇸Decatur, Georgia, United States
Highland Clinic, APMC
🇺🇸Shreveport, Louisiana, United States
CRC of Jackson
🇺🇸Jackson, Mississippi, United States
F. Adam Kawley, MD PA
🇺🇸Houston, Texas, United States
Central Texas Health Research
🇺🇸New Braunfels, Texas, United States
Heartland Research Associates, LLC
🇺🇸Wichita, Kansas, United States
Odyssey Research
🇺🇸Fargo, North Dakota, United States
Florida Research Network, LLC
🇺🇸Gainesville, Florida, United States
Jay Care Medical Center
🇺🇸Lakeland, Florida, United States
Immedicenter
🇺🇸Bloomfield, New Jersey, United States
Wilker/Powers Center for Clinical Studies
🇺🇸St. Cloud, Florida, United States
Waterford Medical Associates
🇺🇸Waterford, Michigan, United States
Fiel Family and Sports Medicine
🇺🇸Tempe, Arizona, United States
Orlando Rangel, M.D., P.A.
🇺🇸Tampa, Florida, United States
Palmetto Family Medicine Center
🇺🇸Pelzer, South Carolina, United States
Innovative Research of West FL, Inc.
🇺🇸Largo, Florida, United States
DeGarmo Institute of Medical Research
🇺🇸Greer, South Carolina, United States
Land Clinical Studies
🇺🇸West Caldwell, New Jersey, United States
Clinical Research Institute
🇺🇸New Orleans, Louisiana, United States
Lynn Institute of the Ozarks
🇺🇸Little Rock, Arkansas, United States
Homestead Clinical Research
🇺🇸Naranja, Florida, United States
NextCare Institute for Clinical Research
🇺🇸Phoenix, Arizona, United States
HOPE Research Institute
🇺🇸Phoenix, Arizona, United States
San Diego Managed Care Group
🇺🇸San Diego, California, United States
Association of International Professionals
🇺🇸Las Vegas, Nevada, United States
Sylvana Research Associates
🇺🇸San Antonio, Texas, United States
ICT - Las Vegas
🇺🇸Las Vegas, Nevada, United States
Hillcrest Clinical Research
🇺🇸Oklahoma City, Oklahoma, United States
Horizons Clinical Research Center, LLC
🇺🇸Denver, Colorado, United States
Quality Clinical Research, Inc.
🇺🇸Omaha, Nebraska, United States
Dr. Meera Dewan PC
🇺🇸Omaha, Nebraska, United States
Newport Beach Clinical Research Associates, Inc.
🇺🇸Newport Beach, California, United States
Santa Barbara Clinical Research Inc.
🇺🇸Santa Barbara, California, United States
Atlantic Institute of Clinical Research
🇺🇸Daytona Beach, Florida, United States
Tampa Bay Medical Research
🇺🇸Clearwater, Florida, United States
Medical Clinic of North Texas
🇺🇸Arlington, Texas, United States
Georgetown Medical Clinic
🇺🇸Georgetown, Texas, United States
Texas Family Care Clinical Research
🇺🇸Colleyville, Texas, United States
Holston Medical Group, P.C.
🇺🇸Weber City, Virginia, United States
GSA Research
🇺🇸San Antonio, Texas, United States
Sun Research Institute
🇺🇸San Antonio, Texas, United States
Central Texas Clinical Research
🇺🇸Austin, Texas, United States
Research Across America
🇺🇸Dallas, Texas, United States
DiscoveResearch, Inc.
🇺🇸Bryan, Texas, United States
Clinical Health Research, LLC
🇺🇸Sugar Land, Texas, United States
Simon Williamson Clinic, PC
🇺🇸Hueytown, Alabama, United States
Gulf Shores General Practice Center
🇺🇸Gulf Shores, Alabama, United States
Vaugh H Mancha Jr., PC Family Practice
🇺🇸Montgomery, Alabama, United States
Brookwood Internists, P.C.
🇺🇸Birmingham, Alabama, United States
Quality of life Medical, LLC
🇺🇸Anaheim, California, United States
ICT - Beverly Hills
🇺🇸Beverly Hills, California, United States
Chrishard Medical Group
🇺🇸Inglewood, California, United States
Impact Clinical Trials and Powerplay
🇺🇸Los Angeles, California, United States
FPA Clinical Research
🇺🇸Kissimmee, Florida, United States
Palm Beach Research center
🇺🇸West Palm Beach, Florida, United States
West Wind'r Research & Development, LLC
🇺🇸Tampa, Florida, United States
Dupage Family Medicine
🇺🇸Naperville, Illinois, United States
PMI Health Research Group
🇺🇸Atlanta, Georgia, United States
Central Kentucky Research Associates, Inc.
🇺🇸Lexington, Kentucky, United States
Bluegrass Orthopaedics & Hand Care Research
🇺🇸Lexington, Kentucky, United States
Dayton Clinical Research
🇺🇸Dayton, Ohio, United States
Parsons Avenue Medical Clinic
🇺🇸Columbus, Ohio, United States
Warminster Medical Association
🇺🇸Warminster, Pennsylvania, United States
Harleysville Medical Associates
🇺🇸Harleysville, Pennsylvania, United States
Clinicos, LLC
🇺🇸Colorado Springs, Colorado, United States