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Trial record 1 of 8 for:    CARISOPRODOL
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Study to Evaluate Two Formulations of Carisoprodol in Subjects With Musculoskeletal Spasm of the Lower Back

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00671879
Recruitment Status : Completed
First Posted : May 5, 2008
Results First Posted : November 21, 2012
Last Update Posted : November 21, 2012
Sponsor:
Information provided by (Responsible Party):
Meda Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Lower Back Pain Drug: Carisoprodol SR 700 mg Drug: Carisoprodol SR 500 mg Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 830 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : April 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: Carisprodol SR 700 mg
Carisoprodol 700 mg twice daily
Drug: Carisoprodol SR 700 mg
700 mg twice daily tablet
Other Name: no other name

Experimental: Carisoprodol SR 500mg
Carisoprodol SR 500 mg twice daily
Drug: Carisoprodol SR 500 mg
carisoprodol SR 500 mg tablet
Other Name: no other name

Placebo Comparator: Placebo
Placebo
Drug: Placebo
placebo tablet
Other Name: no other name




Primary Outcome Measures :
  1. Subject Rated Change Relief From Starting Backache of Pain on a 100-point Visual Analog Scale [ Time Frame: 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 :
  1. Subject Functional Assessment Based on the Roland-Morris Disability Questionnaire (RMDQ) [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00671879


Locations
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United States, Alabama
Brookwood Internists, P.C.
Birmingham, Alabama, United States, 35209
Gulf Shores General Practice Center
Gulf Shores, Alabama, United States, 36547
Simon Williamson Clinic, PC
Hueytown, Alabama, United States, 35023
Vaugh H Mancha Jr., PC Family Practice
Montgomery, Alabama, United States, 36117
United States, Arizona
NextCare Institute for Clinical Research
Phoenix, Arizona, United States, 85016
HOPE Research Institute
Phoenix, Arizona, United States, 85050
Fiel Family and Sports Medicine
Tempe, Arizona, United States, 85283
United States, Arkansas
Lynn Institute of the Ozarks
Little Rock, Arkansas, United States, 72205
United States, California
Quality of life Medical, LLC
Anaheim, California, United States, 92801
ICT - Beverly Hills
Beverly Hills, California, United States, 90211
Lovelace Scientific Resources, Inc.
Burbank, California, United States, 91506
Chrishard Medical Group
Inglewood, California, United States, 90301
Impact Clinical Trials and Powerplay
Los Angeles, California, United States, 90036
Newport Beach Clinical Research Associates, Inc.
Newport Beach, California, United States, 92660
San Diego Managed Care Group
San Diego, California, United States, 92128
Crest Clinical Trials, Inc.
Santa Ana, California, United States, 92701
Santa Barbara Clinical Research Inc.
Santa Barbara, California, United States, 93108
United States, Colorado
Clinicos, LLC
Colorado Springs, Colorado, United States, 80904
Horizons Clinical Research Center, LLC
Denver, Colorado, United States, 80220
United States, Florida
Tampa Bay Medical Research
Clearwater, Florida, United States, 33761
Atlantic Institute of Clinical Research
Daytona Beach, Florida, United States, 32114
Florida Research Network, LLC
Gainesville, Florida, United States, 32605
Orthopaedic Assoc. of S. Broward, P.A.
Hollywood, Florida, United States, 33021
FPA Clinical Research
Kissimmee, Florida, United States, 34741
Jay Care Medical Center
Lakeland, Florida, United States, 33805
Innovative Research of West FL, Inc.
Largo, Florida, United States, 33770
Oslar Medical, Inc./ Osler Clinical Research
Melbourne, Florida, United States, 32901
Homestead Clinical Research
Naranja, Florida, United States, 33032
Andres Patron, DO, PA
Pembroke Pines, Florida, United States, 33026
Wilker/Powers Center for Clinical Studies
St. Cloud, Florida, United States, 34769
Orlando Rangel, M.D., P.A.
Tampa, Florida, United States, 33607
West Wind'r Research & Development, LLC
Tampa, Florida, United States, 33607
Palm Beach Research center
West Palm Beach, Florida, United States, 33409
United States, Georgia
PMI Health Research Group
Atlanta, Georgia, United States, 30312
Perimeter Institute for Clinical Research, Inc.
Atlanta, Georgia, United States, 30338
Best Clinical Research
Decatur, Georgia, United States, 30034
United States, Illinois
Dupage Family Medicine
Naperville, Illinois, United States, 60564
United States, Kansas
Heartland Research Associates, LLC
Wichita, Kansas, United States, 67205
United States, Kentucky
Bluegrass Orthopaedics & Hand Care Research
Lexington, Kentucky, United States, 40509
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, United States, 40509
United States, Louisiana
Clinical Research Institute
New Orleans, Louisiana, United States, 70128
Highland Clinic, APMC
Shreveport, Louisiana, United States, 71105
United States, Michigan
Waterford Medical Associates
Waterford, Michigan, United States, 48328
United States, Mississippi
CRC of Jackson
Jackson, Mississippi, United States, 39202
United States, Nebraska
Quality Clinical Research, Inc.
Omaha, Nebraska, United States, 68114
Dr. Meera Dewan PC
Omaha, Nebraska, United States, 68144
United States, Nevada
Association of International Professionals
Las Vegas, Nevada, United States, 89101
ICT - Las Vegas
Las Vegas, Nevada, United States, 89106
United States, New Jersey
Immedicenter
Bloomfield, New Jersey, United States, 07003
Land Clinical Studies
West Caldwell, New Jersey, United States, 07006
United States, New York
Research Across America
New York, New York, United States, 10022
United States, North Dakota
Odyssey Research
Fargo, North Dakota, United States, 58104
United States, Ohio
Parsons Avenue Medical Clinic
Columbus, Ohio, United States, 43207
Dayton Clinical Research
Dayton, Ohio, United States, 45406
United States, Oklahoma
Hillcrest Clinical Research
Oklahoma City, Oklahoma, United States, 73119
United States, Pennsylvania
Harleysville Medical Associates
Harleysville, Pennsylvania, United States, 19438
Warminster Medical Association
Warminster, Pennsylvania, United States, 18974
United States, South Carolina
DeGarmo Institute of Medical Research
Greer, South Carolina, United States, 29651
Palmetto Family Medicine Center
Pelzer, South Carolina, United States, 29669
United States, Tennessee
Holston Medical Group, P.C.
Kingsport, Tennessee, United States, 37660
United States, Texas
Medical Clinic of North Texas
Arlington, Texas, United States, 76012
Central Texas Clinical Research
Austin, Texas, United States, 78705
DiscoveResearch, Inc.
Bryan, Texas, United States, 77802
Texas Family Care Clinical Research
Colleyville, Texas, United States, 76034
Research Across America
Dallas, Texas, United States, 75234
Georgetown Medical Clinic
Georgetown, Texas, United States, 78626
F. Adam Kawley, MD PA
Houston, Texas, United States, 77024
Central Texas Health Research
New Braunfels, Texas, United States, 78130
GSA Research
San Antonio, Texas, United States, 78213
Sun Research Institute
San Antonio, Texas, United States, 78215
Sylvana Research Associates
San Antonio, Texas, United States, 78229
Clinical Health Research, LLC
Sugar Land, Texas, United States, 77479
United States, Virginia
Holston Medical Group, P.C.
Weber City, Virginia, United States, 24290
Sponsors and Collaborators
Meda Pharmaceuticals
Investigators
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Study Director: Lewis M. Fredane, MD Meda Pharmaceuticals
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Responsible Party: Meda Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00671879    
Other Study ID Numbers: MP511
First Posted: May 5, 2008    Key Record Dates
Results First Posted: November 21, 2012
Last Update Posted: November 21, 2012
Last Verified: October 2012
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Carisoprodol
Muscle Relaxants, Central
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents