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

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ClinicalTrials.gov Identifier: NCT00671879
Recruitment Status : Completed
First Posted : May 5, 2008
Results First Posted : November 21, 2012
Last Update Posted : November 21, 2012
Sponsor:
Information provided by (Responsible Party):
Meda Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE May 1, 2008
First Posted Date  ICMJE May 5, 2008
Results First Submitted Date  ICMJE July 13, 2011
Results First Posted Date  ICMJE November 21, 2012
Last Update Posted Date November 21, 2012
Study Start Date  ICMJE April 2008
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 22, 2012)
Subject Rated Change Relief From Starting Backache of Pain on a 100-point Visual Analog Scale [ Time Frame: baseline to 14 days ]
on a visual analog scale of 0 to 100 millimeters(mm) with 0 being no pain and 100 being maximum pain By measuring the amount of pain before and during treatment done at each visit and recording the difference in mm.During treatment scores were averaged and this average was compared to the baseline value.
Original Primary Outcome Measures  ICMJE
 (submitted: May 2, 2008)
Subject rating of pain on a 100-point visual analog scale [ Time Frame: up to 14 days ]
Change History Complete list of historical versions of study NCT00671879 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 22, 2012)
Subject Functional Assessment Based on the Roland-Morris Disability Questionnaire (RMDQ) [ Time Frame: baseline and day +14 ]
Subject functional assessment based on the Roland-Morris Disability Questionnaire (RMDQ)at day 14.Subjects were asked to read a list of 24 sentences that people have used to describe themselves when they had back pain, and were asked to mark those statements that described their condition that day. The number of marked statements was added. A decrease in the number of marked statements from baseline represented improvement on the RMDQ.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2008)
  • Subject Functional Assessment Based on the Roland-Morris Disability Questionnaire (RMDQ) [ Time Frame: up to 14 days ]
  • Adverse events 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  ICMJE Study to Evaluate Two Formulations of Carisoprodol in Subjects With Musculoskeletal Spasm of the Lower Back
Official Title  ICMJE 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 will be 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 consists of a baseline screening (Study Day 1), during which subjects will be evaluated for inclusion/exclusion criteria, and a 7-day double-blind treatment period (Study Day 1 through Study Day 7). Subjects will be randomly assigned to be dosed twice daily with one of the following double-blind treatments: SR carisoprodol 500-mg tablets, SR carisoprodol 700-mg tablets, or placebo.

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

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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Lower Back Pain
Intervention  ICMJE
  • Drug: Carisoprodol SR 700 mg
    700 mg twice daily tablet
    Other Name: no other name
  • Drug: Carisoprodol SR 500 mg
    carisoprodol SR 500 mg tablet
    Other Name: no other name
  • Drug: Placebo
    placebo tablet
    Other Name: no other name
Study Arms  ICMJE
  • Experimental: Carisprodol SR 700 mg
    Carisoprodol 700 mg twice daily
    Intervention: Drug: Carisoprodol SR 700 mg
  • Experimental: Carisoprodol SR 500mg
    Carisoprodol SR 500 mg twice daily
    Intervention: Drug: Carisoprodol SR 500 mg
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 28, 2011)
830
Original Estimated Enrollment  ICMJE
 (submitted: May 2, 2008)
750
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00671879
Other Study ID Numbers  ICMJE MP511
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Meda Pharmaceuticals
Study Sponsor  ICMJE Meda Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Lewis M. Fredane, MD Meda Pharmaceuticals
PRS Account Meda Pharmaceuticals
Verification Date October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP