A Study to Evaluate Two Formulations of Carisoprodol in Subjects With Musculoskeletal Spasm of the Lower Back

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00671502
• Date of registration: 01/05/2008
• Primary sponsor: Meda Pharmaceuticals
• Public title: A Study to Evaluate Two Formulations of Carisoprodol in Subjects With Musculoskeletal Spasm of the Lower Back
• Scientific 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
• Date of first enrolment: April 2008
• Target sample size: 840
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00671502
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Lewis M. Fredane, MD
• Affiliation: Meda Pharmaceuticals

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 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 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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Lower Back Pain

Intervention(s)

Drug: Carisoprodol SR

Drug: Placebo

Primary Outcome(s)

Subject Rating of Pain on a 100-point Visual Analog Scale (VAS) [Time Frame: up to 14 days]

Secondary Outcome(s)

Adverse Event Assessment [Time Frame: up to 21 days]

Subject Functional Assessment Based on the Roland-Morris Disability Questionnaire (RMDQ) [Time Frame: up to 14 days]

Secondary ID(s)

MP510

Source(s) of Monetary Support

Please refer to primary and secondary sponsors