Study to Evaluate Two Formulations of Carisoprodol in Subjects With Musculoskeletal Spasm of the Lower Back
Condition: Lower Back Pain
MeSH terms: Low Back Pain
Intervention: Carisoprodol SR 700 mg; Carisoprodol SR 500 mg; Placebo
Intervention description: 700 mg twice daily tablet; carisoprodol SR 500 mg tablet; placebo tablet
Intervention MeSH terms: Carisoprodol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 830.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

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

Eligibility 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 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