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
830
1 country
73
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
73 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
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedResults Posted
Study results publicly available
November 21, 2012
CompletedNovember 21, 2012
October 1, 2012
11 months
May 1, 2008
July 13, 2011
October 22, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Subject Rated Change Relief From Starting Backache of Pain on a 100-point Visual Analog Scale
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.
baseline to 14 days
Secondary Outcomes (1)
Subject Functional Assessment Based on the Roland-Morris Disability Questionnaire (RMDQ)
baseline and day +14
Study Arms (3)
Carisprodol SR 700 mg
EXPERIMENTALCarisoprodol 700 mg twice daily
Carisoprodol SR 500mg
EXPERIMENTALCarisoprodol SR 500 mg twice daily
Placebo
PLACEBO COMPARATORPlacebo
Interventions
700 mg twice daily tablet
carisoprodol SR 500 mg tablet
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 VAS
- Ability to discontinue all analgesics, 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 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (73)
Brookwood Internists, P.C.
Birmingham, Alabama, 35209, United States
Gulf Shores General Practice Center
Gulf Shores, Alabama, 36547, United States
Simon Williamson Clinic, PC
Hueytown, Alabama, 35023, United States
Vaugh H Mancha Jr., PC Family Practice
Montgomery, Alabama, 36117, United States
NextCare Institute for Clinical Research
Phoenix, Arizona, 85016, United States
HOPE Research Institute
Phoenix, Arizona, 85050, United States
Fiel Family and Sports Medicine
Tempe, Arizona, 85283, United States
Lynn Institute of the Ozarks
Little Rock, Arkansas, 72205, United States
Quality of life Medical, LLC
Anaheim, California, 92801, United States
ICT - Beverly Hills
Beverly Hills, California, 90211, United States
Lovelace Scientific Resources, Inc.
Burbank, California, 91506, United States
Chrishard Medical Group
Inglewood, California, 90301, United States
Impact Clinical Trials and Powerplay
Los Angeles, California, 90036, United States
Newport Beach Clinical Research Associates, Inc.
Newport Beach, California, 92660, United States
San Diego Managed Care Group
San Diego, California, 92128, United States
Crest Clinical Trials, Inc.
Santa Ana, California, 92701, United States
Santa Barbara Clinical Research Inc.
Santa Barbara, California, 93108, United States
Clinicos, LLC
Colorado Springs, Colorado, 80904, United States
Horizons Clinical Research Center, LLC
Denver, Colorado, 80220, United States
Tampa Bay Medical Research
Clearwater, Florida, 33761, United States
Atlantic Institute of Clinical Research
Daytona Beach, Florida, 32114, United States
Florida Research Network, LLC
Gainesville, Florida, 32605, United States
Orthopaedic Assoc. of S. Broward, P.A.
Hollywood, Florida, 33021, United States
FPA Clinical Research
Kissimmee, Florida, 34741, United States
Jay Care Medical Center
Lakeland, Florida, 33805, United States
Innovative Research of West FL, Inc.
Largo, Florida, 33770, United States
Oslar Medical, Inc./ Osler Clinical Research
Melbourne, Florida, 32901, United States
Homestead Clinical Research
Naranja, Florida, 33032, United States
Andres Patron, DO, PA
Pembroke Pines, Florida, 33026, United States
Wilker/Powers Center for Clinical Studies
Saint Cloud, Florida, 34769, United States
Orlando Rangel, M.D., P.A.
Tampa, Florida, 33607, United States
West Wind'r Research & Development, LLC
Tampa, Florida, 33607, United States
Palm Beach Research center
West Palm Beach, Florida, 33409, United States
PMI Health Research Group
Atlanta, Georgia, 30312, United States
Perimeter Institute for Clinical Research, Inc.
Atlanta, Georgia, 30338, United States
Best Clinical Research
Decatur, Georgia, 30034, United States
Dupage Family Medicine
Naperville, Illinois, 60564, United States
Heartland Research Associates, LLC
Wichita, Kansas, 67205, United States
Bluegrass Orthopaedics & Hand Care Research
Lexington, Kentucky, 40509, United States
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, 40509, United States
Clinical Research Institute
New Orleans, Louisiana, 70128, United States
Highland Clinic, APMC
Shreveport, Louisiana, 71105, United States
Waterford Medical Associates
Waterford, Michigan, 48328, United States
CRC of Jackson
Jackson, Mississippi, 39202, United States
Quality Clinical Research, Inc.
Omaha, Nebraska, 68114, United States
Dr. Meera Dewan PC
Omaha, Nebraska, 68144, United States
Association of International Professionals
Las Vegas, Nevada, 89101, United States
ICT - Las Vegas
Las Vegas, Nevada, 89106, United States
Immedicenter
Bloomfield, New Jersey, 07003, United States
Land Clinical Studies
West Caldwell, New Jersey, 07006, United States
Research Across America
New York, New York, 10022, United States
Odyssey Research
Fargo, North Dakota, 58104, United States
Parsons Avenue Medical Clinic
Columbus, Ohio, 43207, United States
Dayton Clinical Research
Dayton, Ohio, 45406, United States
Hillcrest Clinical Research
Oklahoma City, Oklahoma, 73119, United States
Harleysville Medical Associates
Harleysville, Pennsylvania, 19438, United States
Warminster Medical Association
Warminster, Pennsylvania, 18974, United States
DeGarmo Institute of Medical Research
Greer, South Carolina, 29651, United States
Palmetto Family Medicine Center
Pelzer, South Carolina, 29669, United States
Holston Medical Group, P.C.
Kingsport, Tennessee, 37660, United States
Medical Clinic of North Texas
Arlington, Texas, 76012, United States
Central Texas Clinical Research
Austin, Texas, 78705, United States
DiscoveResearch, Inc.
Bryan, Texas, 77802, United States
Texas Family Care Clinical Research
Colleyville, Texas, 76034, United States
Research Across America
Dallas, Texas, 75234, United States
Georgetown Medical Clinic
Georgetown, Texas, 78626, United States
F. Adam Kawley, MD PA
Houston, Texas, 77024, United States
Central Texas Health Research
New Braunfels, Texas, 78130, United States
GSA Research
San Antonio, Texas, 78213, United States
Sun Research Institute
San Antonio, Texas, 78215, United States
Sylvana Research Associates
San Antonio, Texas, 78229, United States
Clinical Health Research, LLC
Sugar Land, Texas, 77479, United States
Holston Medical Group, P.C.
Weber City, Virginia, 24290, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- David Ginsberg, DO Sr Dir Medical Scientific Affairs
- 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
March 1, 2009
Study Completion
March 1, 2009
Last Updated
November 21, 2012
Results First Posted
November 21, 2012
Record last verified: 2012-10