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

October 4, 2011 updated by: Meda Pharmaceuticals

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

840

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35235
        • MedSearch, LLC
      • Huntsville, Alabama, United States, 35802
        • Genesis Clinical Research Corporation
      • Montgomery, Alabama, United States, 36117
        • Vaughn H. Mancha, Jr., PC Family Practice
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Anasazi Internal Medicine PC
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • Heritage Physician Group
      • Little Rock, Arkansas, United States, 72205
        • Orthoarkansas
      • North Little Rock, Arkansas, United States, 72114
        • Family Practice Clinic
    • California
      • Hawaiian Gardens, California, United States, 90716
        • Quality of Life Medical Center, LLC
      • Roseville, California, United States, 95661
        • Trinity Health and Wellness
      • San Diego, California, United States, 92120
        • San Diego Sports Medicine & Family Health Center
      • Vista, California, United States, 92084
        • Quality Care Medical Center, Inc.
    • Connecticut
      • Avon, Connecticut, United States, 06001
        • Anthony Roselli, MD
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Clinical Research of South Florida
      • Gainesville, Florida, United States, 32607
        • Southeastern Integrated Medical, PL dba Florida Medical Research Institute
      • Hollywood, Florida, United States, 33023
        • South Florida Clinical Research Center
      • Kissimmee, Florida, United States, 34741
        • FPA Clinical Research
      • Longwood, Florida, United States, 32779
        • Genesis Research International
      • Miami, Florida, United States, 33143
        • Well Pharma Medical Research Corporation
      • Miami, Florida, United States, 33156
        • International Research Associates, LLC
      • Miami, Florida, United States, 33180
        • TuKoi Clinical Research
      • Ocala, Florida, United States, 34471
        • Renstar Medical Research
      • Pembroke Pines, Florida, United States, 33024
        • University Clinical Research, Inc.
      • Plantation, Florida, United States, 33324
        • Sunrise Medical Research #501
      • Tampa, Florida, United States, 33609
        • Southwest Florida Clinical Research Center
      • West Palm Beach, Florida, United States, 33409
        • Palm Beach Research Center
    • Georgia
      • Atlanta, Georgia, United States, 30338
        • Perimeter Institute for Clinical Research, Inc.
    • Louisiana
      • Sunset, Louisiana, United States, 70584
        • Sunset Medical Research
    • Massachusetts
      • Worcester, Massachusetts, United States, 01610
        • Clinical Pharmacology Study Group
    • Michigan
      • Buckley, Michigan, United States, 49620
        • Northern Pines Health Center
      • Clair Shores, Michigan, United States, 48081
        • KMED Research
      • Detroit, Michigan, United States, 48235
        • Harris & Associates, P.C.
      • Flint, Michigan, United States, 48507
        • Valley Medical Center
      • Kalamazoo, Michigan, United States, 49009
        • Westside Family Medical Center, P.C.
    • Missouri
      • Kansas City, Missouri, United States, 64106
        • Kansas City University of Medicine and BioSciences Dybedal Building
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Comprehensive Clinical Research
      • Blackwood, New Jersey, United States, 08012
        • South Jersey Medical Associations, PA
      • Hamilton, New Jersey, United States, 08610
        • Care Center of Family Practice & Pediatrics of Hamilton
      • Voorhees, New Jersey, United States, 08043
        • Partners in Primary Care
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Albuquerque Clinical Trials, Inc.
    • North Carolina
      • Charlotte, North Carolina, United States, 28209
        • Metrolina Medical Research
    • Ohio
      • Perrysburg, Ohio, United States, 43551
        • Clinical Research Source Inc.
      • Wadsworth, Ohio, United States, 44281
        • Family Practice Center Of Wadsworth, Inc.
    • Oregon
      • Ashland, Oregon, United States, 97520
        • Integrated Medical Research
      • Eugene, Oregon, United States, 91404
        • Williamette Valley Clinical Studies
      • Portland, Oregon, United States, 97219
        • Fanno Creek Clinic, LLC
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Best Clinical Research - PA
      • Philadelphia, Pennsylvania, United States, 19142
        • Arcuri Clinical Research
    • Rhode Island
      • Cumberland, Rhode Island, United States, 02864
        • Partners in Clinical Research
      • Warwick, Rhode Island, United States, 02886
        • Omega Medical Research
    • South Carolina
      • Manning, South Carolina, United States, 29102
        • Robert S. Eagerton Jr., MD Family Practice
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • Holston Medical Group, P.C.
    • Texas
      • Addison, Texas, United States, 75001
        • ACRC Trials
      • Arlington, Texas, United States, 76012
        • Arlington Family Health Pavilion
      • Austin, Texas, United States, 78705
        • Central TX Clinical Research
      • Bedford, Texas, United States, 76021
        • Mid-Cities Family Care
      • Bellaire, Texas, United States, 77401
        • Evergreen Clinical Research, LLC
      • Deer Park, Texas, United States, 77536
        • Deer Park Family Clinic, P.A.
      • Houston, Texas, United States, 77055
        • West Houston Clinical Research
      • Houston, Texas, United States, 77024
        • Prime Care Medical Group
      • North Richland Hills, Texas, United States, 76180
        • North Hills Family Practice
      • Plano, Texas, United States, 75093
        • North Texas Family Medicine
      • San Antonio, Texas, United States, 78218
        • Oakwell Clinical Research
      • San Antonio, Texas, United States, 78217
        • Unlimited Research
      • San Antonio, Texas, United States, 78205
        • Sun Research Institute
      • San Antonio, Texas, United States, 78218
        • InVisions Consultants, LLC
    • Virginia
      • Newport News, Virginia, United States, 23606
        • Health Research of Hampton Roads, Inc.
      • Richmond, Virginia, United States, 23230
        • Medical Research Initiatives
    • Washington
      • Tacoma, Washington, United States, 98405
        • Liberty Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Carisoprodol 700mg
tablet sustained release (SR)
Drug: Carisoprodol SR
700 mg twice daily
Other Names:
  • sustained release(SR)
Drug: Carisoprodol SR
500 mg twice daily
Other Names:
  • sustained release(SR) tablet
Experimental: Carisoprodol 500mg
sustained release(SR) tablet
Drug: Carisoprodol SR
700 mg twice daily
Other Names:
  • sustained release(SR)
Drug: Carisoprodol SR
500 mg twice daily
Other Names:
  • sustained release(SR) tablet
Placebo Comparator: Placebo
tablet
Drug: Placebo
Placebo tablet
Other Names:
  • no other name

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subject Functional Assessment Based on the Roland-Morris Disability Questionnaire (RMDQ)
Time Frame: up to 14 days
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
up to 21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meda Pharmaceuticals

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

May 1, 2008

First Submitted That Met QC Criteria

May 1, 2008

First Posted (Estimate)

May 5, 2008

Study Record Updates

Last Update Posted (Estimate)

November 9, 2011

Last Update Submitted That Met QC Criteria

October 4, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MP510

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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