Lower Back Pain Clinical Trial
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
Verified date | October 2012 |
Source | Meda Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The purpose of this study is to determine if two sustained released formulations of carisoprodol are more effective than placebo.
Status | Completed |
Enrollment | 830 |
Est. completion date | March 2009 |
Est. primary completion date | March 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Quality of life Medical, LLC | Anaheim | California |
United States | Medical Clinic of North Texas | Arlington | Texas |
United States | Perimeter Institute for Clinical Research, Inc. | Atlanta | Georgia |
United States | PMI Health Research Group | Atlanta | Georgia |
United States | Central Texas Clinical Research | Austin | Texas |
United States | ICT - Beverly Hills | Beverly Hills | California |
United States | Brookwood Internists, P.C. | Birmingham | Alabama |
United States | Immedicenter | Bloomfield | New Jersey |
United States | DiscoveResearch, Inc. | Bryan | Texas |
United States | Lovelace Scientific Resources, Inc. | Burbank | California |
United States | Tampa Bay Medical Research | Clearwater | Florida |
United States | Texas Family Care Clinical Research | Colleyville | Texas |
United States | Clinicos, LLC | Colorado Springs | Colorado |
United States | Parsons Avenue Medical Clinic | Columbus | Ohio |
United States | Research Across America | Dallas | Texas |
United States | Dayton Clinical Research | Dayton | Ohio |
United States | Atlantic Institute of Clinical Research | Daytona Beach | Florida |
United States | Best Clinical Research | Decatur | Georgia |
United States | Horizons Clinical Research Center, LLC | Denver | Colorado |
United States | Odyssey Research | Fargo | North Dakota |
United States | Florida Research Network, LLC | Gainesville | Florida |
United States | Georgetown Medical Clinic | Georgetown | Texas |
United States | DeGarmo Institute of Medical Research | Greer | South Carolina |
United States | Gulf Shores General Practice Center | Gulf Shores | Alabama |
United States | Harleysville Medical Associates | Harleysville | Pennsylvania |
United States | Orthopaedic Assoc. of S. Broward, P.A. | Hollywood | Florida |
United States | F. Adam Kawley, MD PA | Houston | Texas |
United States | Simon Williamson Clinic, PC | Hueytown | Alabama |
United States | Chrishard Medical Group | Inglewood | California |
United States | CRC of Jackson | Jackson | Mississippi |
United States | Holston Medical Group, P.C. | Kingsport | Tennessee |
United States | FPA Clinical Research | Kissimmee | Florida |
United States | Jay Care Medical Center | Lakeland | Florida |
United States | Innovative Research of West FL, Inc. | Largo | Florida |
United States | Association of International Professionals | Las Vegas | Nevada |
United States | ICT - Las Vegas | Las Vegas | Nevada |
United States | Bluegrass Orthopaedics & Hand Care Research | Lexington | Kentucky |
United States | Central Kentucky Research Associates, Inc. | Lexington | Kentucky |
United States | Lynn Institute of the Ozarks | Little Rock | Arkansas |
United States | Impact Clinical Trials and Powerplay | Los Angeles | California |
United States | Oslar Medical, Inc./ Osler Clinical Research | Melbourne | Florida |
United States | Vaugh H Mancha Jr., PC Family Practice | Montgomery | Alabama |
United States | Dupage Family Medicine | Naperville | Illinois |
United States | Homestead Clinical Research | Naranja | Florida |
United States | Central Texas Health Research | New Braunfels | Texas |
United States | Clinical Research Institute | New Orleans | Louisiana |
United States | Research Across America | New York | New York |
United States | Newport Beach Clinical Research Associates, Inc. | Newport Beach | California |
United States | Hillcrest Clinical Research | Oklahoma City | Oklahoma |
United States | Dr. Meera Dewan PC | Omaha | Nebraska |
United States | Quality Clinical Research, Inc. | Omaha | Nebraska |
United States | Palmetto Family Medicine Center | Pelzer | South Carolina |
United States | Andres Patron, DO, PA | Pembroke Pines | Florida |
United States | HOPE Research Institute | Phoenix | Arizona |
United States | NextCare Institute for Clinical Research | Phoenix | Arizona |
United States | GSA Research | San Antonio | Texas |
United States | Sun Research Institute | San Antonio | Texas |
United States | Sylvana Research Associates | San Antonio | Texas |
United States | San Diego Managed Care Group | San Diego | California |
United States | Crest Clinical Trials, Inc. | Santa Ana | California |
United States | Santa Barbara Clinical Research Inc. | Santa Barbara | California |
United States | Highland Clinic, APMC | Shreveport | Louisiana |
United States | Wilker/Powers Center for Clinical Studies | St. Cloud | Florida |
United States | Clinical Health Research, LLC | Sugar Land | Texas |
United States | Orlando Rangel, M.D., P.A. | Tampa | Florida |
United States | West Wind'r Research & Development, LLC | Tampa | Florida |
United States | Fiel Family and Sports Medicine | Tempe | Arizona |
United States | Warminster Medical Association | Warminster | Pennsylvania |
United States | Waterford Medical Associates | Waterford | Michigan |
United States | Holston Medical Group, P.C. | Weber City | Virginia |
United States | Land Clinical Studies | West Caldwell | New Jersey |
United States | Palm Beach Research center | West Palm Beach | Florida |
United States | Heartland Research Associates, LLC | Wichita | Kansas |
Lead Sponsor | Collaborator |
---|---|
Meda Pharmaceuticals |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | Subject Functional Assessment Based on the Roland-Morris Disability Questionnaire (RMDQ) | 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. | baseline and day +14 | No |
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