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A Study to Evaluate Two Formulations of Carisoprodol in Subjects With Musculoskeletal Spasm of the Lower Back
This study is currently recruiting participants.
Verified by Meda Pharmaceuticals, December 2008
Sponsored by: Meda Pharmaceuticals
Information provided by: Meda Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00671502
  Purpose

The purpose of this study is to determine if two sustained released formulations of carisoprodol are more effective than placebo.


Condition Intervention Phase
Lower Back Pain
Drug: Carisoprodol
Drug: Carisoprodol SR
Drug: Placebo
Phase III

MedlinePlus related topics: Back Pain
Drug Information available for: Carisoprodol
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Meda Pharmaceuticals:

Primary Outcome Measures:
  • Subject rating of pain on a 100-point visual analog scale (VAS) [ Time Frame: up to 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subject functional assessment based on the Roland-Morris Disability Questionnaire (RMDQ) [ Time Frame: up to 14 days ] [ Designated as safety issue: No ]
  • Adverse events assessments [ Time Frame: up to 21 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 840
Study Start Date: April 2008
Estimated Study Completion Date: February 2009
Estimated Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Carisoprodol 700mg: Experimental Drug: Carisoprodol
700 mg twice daily
Carisoprodol 500mg: Experimental Drug: Carisoprodol SR
500 mg twice daily
Placebo: Placebo Comparator Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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 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 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 (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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00671502

Contacts
Contact: Carrie L. D'Andrea, MS 732-564-2538

  Show 64 Study Locations
Sponsors and Collaborators
Meda Pharmaceuticals
Investigators
Study Director: Lewis M. Fredane, MD Meda Pharmaceuticals
  More Information

Responsible Party: Meda Pharmaceuticals ( Harry Sacks, MD Vice President, Medical and Scientific Affairs )
Study ID Numbers: MP510
Study First Received: May 1, 2008
Last Updated: December 22, 2008
ClinicalTrials.gov Identifier: NCT00671502  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Spasm
Carisoprodol
Signs and Symptoms
Neurologic Manifestations
Low Back Pain
Pain
Back Pain

Additional relevant MeSH terms:
Therapeutic Uses
Muscle Relaxants, Central
Physiological Effects of Drugs
Nervous System Diseases
Neuromuscular Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009