Status:
COMPLETED
A Study to Evaluate Two Formulations of Carisoprodol in Subjects With Musculoskeletal Spasm of the Lower Back
Lead Sponsor:
Meda Pharmaceuticals
Conditions:
Lower Back Pain
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine if two sustained released formulations of carisoprodol are more effective than placebo.
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
840 Patients enrolled
Trial Details
Trial ID
NCT00671502
Start Date
April 1 2008
End Date
February 1 2009
Last Update
November 9 2011
Active Locations (68)
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1
MedSearch, LLC
Birmingham, Alabama, United States, 35235
2
Genesis Clinical Research Corporation
Huntsville, Alabama, United States, 35802
3
Vaughn H. Mancha, Jr., PC Family Practice
Montgomery, Alabama, United States, 36117
4
Anasazi Internal Medicine PC
Phoenix, Arizona, United States, 85032