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

• ClinicalTrials.gov Identifier: NCT00671502
• Recruitment Status: Completed
• First Posted: May 5, 2008
• Results First Posted: November 9, 2011
• Last Update Posted: November 9, 2011
• Sponsor: Meda Pharmaceuticals
• Information provided by (Responsible Party): Meda Pharmaceuticals

Tracking Information

• First Submitted Date: May 1, 2008
• First Posted Date: May 5, 2008
• Results First Submitted Date: June 28, 2011
• Results First Posted Date: November 9, 2011
• Last Update Posted Date: November 9, 2011
• Study Start Date: April 2008
• Actual Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 4, 2011)

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

the scale used was from 0 to 100 mm. 0 equaled no pain and 100 equaled maximum pain.participants measure their pain before treatment and during treatment at each visit

• Original Primary Outcome Measures (submitted: May 1, 2008): Subject Rating of Pain on a 100-point Visual Analog Scale (VAS) [ Time Frame: up to 14 days ]

Current Secondary Outcome Measures (submitted: October 4, 2011)

• Subject Functional Assessment Based on the Roland-Morris Disability Questionnaire (RMDQ) [ Time Frame: up to 14 days ]
• Adverse Event Assessment [ Time Frame: up to 21 days ]
  the number of adverse events reported during the course of the study as reported by the participants

Original Secondary Outcome Measures (submitted: May 1, 2008)

• Subject Functional Assessment Based on the Roland-Morris Disability Questionnaire (RMDQ) [ Time Frame: up to 14 days ]
• Adverse Event Assessment [ Time Frame: up to 21 days ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study to Evaluate Two Formulations of Carisoprodol in Subjects With Musculoskeletal Spasm of the Lower Back
• 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
• 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 consisted of a baseline screening (Study Day 1), during which subjects were evaluated for inclusion/exclusion criteria, and a 7-day double-blind treatment period (Study Day 1 through Study Day 7). Subjects were randomly assigned to be dosed twice daily with one of the following double-blind treatments: sustained release(SR) carisoprodol 500-mg tablets,sustained release (SR) carisoprodol 700-mg tablets, or placebo.

Subjects were evaluated in the clinic on Study Days 1, 3 and 7. Subjects who remained symptomatic on Study Day 7 were allowed to continue in the study for a 7-day, double-blind extension period at the discretion of the Investigator. Subjects were contacted by telephone for a safety follow-up 7 days after the last dose of study medication.

A pharmacokinetic (PK) substudy was conducted at selected sites. These sites obtained blood samples for PK analysis at the end of the 7-day treatment period and the 14-day treatment period, if applicable.

• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Lower Back Pain

Intervention

• Drug: Carisoprodol SR
  700 mg twice daily
  Other Name: sustained release(SR)
• Drug: Carisoprodol SR
  500 mg twice daily
  Other Name: sustained release(SR) tablet
• Drug: Placebo
  Placebo tablet
  Other Name: no other name

Study Arms

• Experimental: Carisoprodol 700mg
  tablet sustained release (SR)
  Intervention: Drug: Carisoprodol SR
• Experimental: Carisoprodol 500mg
  sustained release(SR) tablet
  Intervention: Drug: Carisoprodol SR
• Placebo Comparator: Placebo
  tablet
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 22, 2008): 840
• Original Estimated Enrollment (submitted: May 1, 2008): 750
• Actual Study Completion Date: February 2009
• Actual Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)

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 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00671502
• Other Study ID Numbers: MP510
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Meda Pharmaceuticals
• Study Sponsor: Meda Pharmaceuticals
• Collaborators: Not Provided

Investigators

• Study Director: Lewis M. Fredane, MD; Meda Pharmaceuticals

• PRS Account: Meda Pharmaceuticals
• Verification Date: October 2011