A Study to Evaluate Two Formulations of Carisoprodol in Subjects With Musculoskeletal Spasm of the Lower Back
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
1 other identifier
interventional
840
1 country
68
Brief Summary
The purpose of this study is to determine if two sustained released formulations of carisoprodol are more effective than placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2008
Shorter than P25 for phase_3
68 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 1, 2008
CompletedFirst Posted
Study publicly available on registry
May 5, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedResults Posted
Study results publicly available
November 9, 2011
CompletedNovember 9, 2011
October 1, 2011
10 months
May 1, 2008
June 28, 2011
October 4, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Subject Rating of Pain on a 100-point Visual Analog Scale (VAS)
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
up to 14 days
Secondary Outcomes (2)
Subject Functional Assessment Based on the Roland-Morris Disability Questionnaire (RMDQ)
up to 14 days
Adverse Event Assessment
up to 21 days
Study Arms (3)
Carisoprodol 700mg
EXPERIMENTALtablet sustained release (SR)
Carisoprodol 500mg
EXPERIMENTALsustained release(SR) tablet
Placebo
PLACEBO COMPARATORtablet
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (68)
MedSearch, LLC
Birmingham, Alabama, 35235, United States
Genesis Clinical Research Corporation
Huntsville, Alabama, 35802, United States
Vaughn H. Mancha, Jr., PC Family Practice
Montgomery, Alabama, 36117, United States
Anasazi Internal Medicine PC
Phoenix, Arizona, 85032, United States
Heritage Physician Group
Hot Springs, Arkansas, 71913, United States
OrthoArkansas
Little Rock, Arkansas, 72205, United States
Family Practice Clinic
North Little Rock, Arkansas, 72114, United States
Quality of Life Medical Center, LLC
Hawaiian Gardens, California, 90716, United States
Trinity Health and Wellness
Roseville, California, 95661, United States
San Diego Sports Medicine & Family Health Center
San Diego, California, 92120, United States
Quality Care Medical Center, Inc.
Vista, California, 92084, United States
Anthony Roselli, MD
Avon, Connecticut, 06001, United States
Clinical Research of South Florida
Coral Gables, Florida, 33134, United States
Southeastern Integrated Medical, PL dba Florida Medical Research Institute
Gainesville, Florida, 32607, United States
South Florida Clinical Research Center
Hollywood, Florida, 33023, United States
FPA Clinical Research
Kissimmee, Florida, 34741, United States
Genesis Research International
Longwood, Florida, 32779, United States
Well Pharma Medical Research Corporation
Miami, Florida, 33143, United States
International Research Associates, LLC
Miami, Florida, 33156, United States
Tukoi Clinical Research
Miami, Florida, 33180, United States
Renstar Medical Research
Ocala, Florida, 34471, United States
University Clinical Research, Inc.
Pembroke Pines, Florida, 33024, United States
Sunrise Medical Research #501
Plantation, Florida, 33324, United States
Southwest Florida Clinical Research Center
Tampa, Florida, 33609, United States
Palm Beach Research Center
West Palm Beach, Florida, 33409, United States
Perimeter Institute for Clinical Research, Inc.
Atlanta, Georgia, 30338, United States
Sunset Medical Research
Sunset, Louisiana, 70584, United States
Clinical Pharmacology Study Group
Worcester, Massachusetts, 01610, United States
Northern Pines Health Center
Buckley, Michigan, 49620, United States
KMED Research
Clair Shores, Michigan, 48081, United States
Harris & Associates, P.C.
Detroit, Michigan, 48235, United States
Valley Medical Center
Flint, Michigan, 48507, United States
Westside Family Medical Center, P.C.
Kalamazoo, Michigan, 49009, United States
Kansas City University of Medicine and BioSciences Dybedal Building
Kansas City, Missouri, 64106, United States
Comprehensive Clinical Research
Berlin, New Jersey, 08009, United States
South Jersey Medical Associations, PA
Blackwood, New Jersey, 08012, United States
Care Center of Family Practice & Pediatrics of Hamilton
Hamilton, New Jersey, 08610, United States
Partners in Primary Care
Voorhees Township, New Jersey, 08043, United States
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, 87102, United States
Metrolina Medical Research
Charlotte, North Carolina, 28209, United States
Clinical Research Source Inc.
Perrysburg, Ohio, 43551, United States
Family Practice Center of Wadsworth, Inc.
Wadsworth, Ohio, 44281, United States
Integrated Medical Research
Ashland, Oregon, 97520, United States
Williamette Valley Clinical Studies
Eugene, Oregon, 91404, United States
Fanno Creek Clinic, LLC
Portland, Oregon, 97219, United States
Best Clinical Research - PA
Philadelphia, Pennsylvania, 19104, United States
Arcuri Clinical Research
Philadelphia, Pennsylvania, 19142, United States
Partners in Clinical Research
Cumberland, Rhode Island, 02864, United States
Omega Medical Research
Warwick, Rhode Island, 02886, United States
Robert S. Eagerton Jr., MD Family Practice
Manning, South Carolina, 29102, United States
Holston Medical Group, P.C.
Bristol, Tennessee, 37620, United States
ACRC Trials
Addison, Texas, 75001, United States
Arlington Family Health Pavilion
Arlington, Texas, 76012, United States
Central TX Clinical Research
Austin, Texas, 78705, United States
Mid-Cities Family Care
Bedford, Texas, 76021, United States
Evergreen Clinical Research, LLC
Bellaire, Texas, 77401, United States
Deer Park Family Clinic, P.A.
Deer Park, Texas, 77536, United States
Prime Care Medical Group
Houston, Texas, 77024, United States
West Houston Clinical Research
Houston, Texas, 77055, United States
North Hills Family Practice
North Richland Hills, Texas, 76180, United States
North Texas Family Medicine
Plano, Texas, 75093, United States
Sun Research Institute
San Antonio, Texas, 78205, United States
Unlimited Research
San Antonio, Texas, 78217, United States
InVisions Consultants, LLC
San Antonio, Texas, 78218, United States
Oakwell Clinical Research
San Antonio, Texas, 78218, United States
Health Research of Hampton Roads, Inc.
Newport News, Virginia, 23606, United States
Medical Research Initiatives
Richmond, Virginia, 23230, United States
Liberty Research Center
Tacoma, Washington, 98405, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- David Ginsberg, MD Sr Medical Director
- Organization
- Meda Pharma US
Study Officials
- STUDY DIRECTOR
Lewis M. Fredane, MD
Meda Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 1, 2008
First Posted
May 5, 2008
Study Start
April 1, 2008
Primary Completion
February 1, 2009
Study Completion
February 1, 2009
Last Updated
November 9, 2011
Results First Posted
November 9, 2011
Record last verified: 2011-10