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Trial record 2 of 8 for:    CARISOPRODOL

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

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ClinicalTrials.gov Identifier: NCT00671502
Recruitment Status : Completed
First Posted : May 5, 2008
Results First Posted : November 9, 2011
Last Update Posted : November 9, 2011
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 Drug: Placebo Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 840 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 : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Carisoprodol 700mg
tablet sustained release (SR)
Drug: Carisoprodol SR
700 mg twice daily
Other Name: sustained release(SR)

Experimental: Carisoprodol 500mg
sustained release(SR) tablet
Drug: Carisoprodol SR
500 mg twice daily
Other Name: sustained release(SR) tablet

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




Primary Outcome Measures :
  1. Subject Rating of Pain on a 100-point Visual Analog Scale (VAS) [ Time Frame: 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 :
  1. Subject Functional Assessment Based on the Roland-Morris Disability Questionnaire (RMDQ) [ Time Frame: up to 14 days ]
  2. Adverse Event Assessment [ Time Frame: up to 21 days ]
    the number of adverse events reported during the course of the study as reported by the participants



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 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

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 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

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): NCT00671502


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Locations
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United States, Alabama
MedSearch, LLC
Birmingham, Alabama, United States, 35235
Genesis Clinical Research Corporation
Huntsville, Alabama, United States, 35802
Vaughn H. Mancha, Jr., PC Family Practice
Montgomery, Alabama, United States, 36117
United States, Arizona
Anasazi Internal Medicine PC
Phoenix, Arizona, United States, 85032
United States, Arkansas
Heritage Physician Group
Hot Springs, Arkansas, United States, 71913
OrthoArkansas
Little Rock, Arkansas, United States, 72205
Family Practice Clinic
North Little Rock, Arkansas, United States, 72114
United States, California
Quality of Life Medical Center, LLC
Hawaiian Gardens, California, United States, 90716
Trinity Health and Wellness
Roseville, California, United States, 95661
San Diego Sports Medicine & Family Health Center
San Diego, California, United States, 92120
Quality Care Medical Center, Inc.
Vista, California, United States, 92084
United States, Connecticut
Anthony Roselli, MD
Avon, Connecticut, United States, 06001
United States, Florida
Clinical Research of South Florida
Coral Gables, Florida, United States, 33134
Southeastern Integrated Medical, PL dba Florida Medical Research Institute
Gainesville, Florida, United States, 32607
South Florida Clinical Research Center
Hollywood, Florida, United States, 33023
FPA Clinical Research
Kissimmee, Florida, United States, 34741
Genesis Research International
Longwood, Florida, United States, 32779
Well Pharma Medical Research Corporation
Miami, Florida, United States, 33143
International Research Associates, LLC
Miami, Florida, United States, 33156
Tukoi Clinical Research
Miami, Florida, United States, 33180
Renstar Medical Research
Ocala, Florida, United States, 34471
University Clinical Research, Inc.
Pembroke Pines, Florida, United States, 33024
Sunrise Medical Research #501
Plantation, Florida, United States, 33324
Southwest Florida Clinical Research Center
Tampa, Florida, United States, 33609
Palm Beach Research Center
West Palm Beach, Florida, United States, 33409
United States, Georgia
Perimeter Institute for Clinical Research, Inc.
Atlanta, Georgia, United States, 30338
United States, Louisiana
Sunset Medical Research
Sunset, Louisiana, United States, 70584
United States, Massachusetts
Clinical Pharmacology Study Group
Worcester, Massachusetts, United States, 01610
United States, Michigan
Northern Pines Health Center
Buckley, Michigan, United States, 49620
KMED Research
Clair Shores, Michigan, United States, 48081
Harris & Associates, P.C.
Detroit, Michigan, United States, 48235
Valley Medical Center
Flint, Michigan, United States, 48507
Westside Family Medical Center, P.C.
Kalamazoo, Michigan, United States, 49009
United States, Missouri
Kansas City University of Medicine and BioSciences Dybedal Building
Kansas City, Missouri, United States, 64106
United States, New Jersey
Comprehensive Clinical Research
Berlin, New Jersey, United States, 08009
South Jersey Medical Associations, PA
Blackwood, New Jersey, United States, 08012
Care Center of Family Practice & Pediatrics of Hamilton
Hamilton, New Jersey, United States, 08610
Partners in Primary Care
Voorhees, New Jersey, United States, 08043
United States, New Mexico
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, United States, 87102
United States, North Carolina
Metrolina Medical Research
Charlotte, North Carolina, United States, 28209
United States, Ohio
Clinical Research Source Inc.
Perrysburg, Ohio, United States, 43551
Family Practice Center of Wadsworth, Inc.
Wadsworth, Ohio, United States, 44281
United States, Oregon
Integrated Medical Research
Ashland, Oregon, United States, 97520
Williamette Valley Clinical Studies
Eugene, Oregon, United States, 91404
Fanno Creek Clinic, LLC
Portland, Oregon, United States, 97219
United States, Pennsylvania
Best Clinical Research - PA
Philadelphia, Pennsylvania, United States, 19104
Arcuri Clinical Research
Philadelphia, Pennsylvania, United States, 19142
United States, Rhode Island
Partners in Clinical Research
Cumberland, Rhode Island, United States, 02864
Omega Medical Research
Warwick, Rhode Island, United States, 02886
United States, South Carolina
Robert S. Eagerton Jr., MD Family Practice
Manning, South Carolina, United States, 29102
United States, Tennessee
Holston Medical Group, P.C.
Bristol, Tennessee, United States, 37620
United States, Texas
ACRC Trials
Addison, Texas, United States, 75001
Arlington Family Health Pavilion
Arlington, Texas, United States, 76012
Central TX Clinical Research
Austin, Texas, United States, 78705
Mid-Cities Family Care
Bedford, Texas, United States, 76021
Evergreen Clinical Research, LLC
Bellaire, Texas, United States, 77401
Deer Park Family Clinic, P.A.
Deer Park, Texas, United States, 77536
Prime Care Medical Group
Houston, Texas, United States, 77024
West Houston Clinical Research
Houston, Texas, United States, 77055
North Hills Family Practice
North Richland Hills, Texas, United States, 76180
North Texas Family Medicine
Plano, Texas, United States, 75093
Sun Research Institute
San Antonio, Texas, United States, 78205
Unlimited Research
San Antonio, Texas, United States, 78217
InVisions Consultants, LLC
San Antonio, Texas, United States, 78218
Oakwell Clinical Research
San Antonio, Texas, United States, 78218
United States, Virginia
Health Research of Hampton Roads, Inc.
Newport News, Virginia, United States, 23606
Medical Research Initiatives
Richmond, Virginia, United States, 23230
United States, Washington
Liberty Research Center
Tacoma, Washington, United States, 98405
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: NCT00671502     History of Changes
Other Study ID Numbers: MP510
First Posted: May 5, 2008    Key Record Dates
Results First Posted: November 9, 2011
Last Update Posted: November 9, 2011
Last Verified: October 2011

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