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

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: Lower Back Pain
• Intervention / Treatment: Drug: Carisoprodol SR 700 mg; Drug: Carisoprodol SR 500 mg; Drug: 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: Interventional
• Enrollment (Actual): 830
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Brookwood Internists, P.C.
    • Gulf Shores, Alabama, United States, 36547
      • Gulf Shores General Practice Center
    • Hueytown, Alabama, United States, 35023
      • Simon Williamson Clinic, PC
    • Montgomery, Alabama, United States, 36117
      • Vaugh H Mancha Jr., PC Family Practice
  • Arizona
    • Phoenix, Arizona, United States, 85050
      • HOPE Research Institute
    • Phoenix, Arizona, United States, 85016
      • NextCare Institute For Clinical Research
    • Tempe, Arizona, United States, 85283
      • Fiel Family and Sports Medicine
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Lynn Institute of the Ozarks
  • California
    • Anaheim, California, United States, 92801
      • Quality of life Medical, LLC
    • Beverly Hills, California, United States, 90211
      • ICT - Beverly Hills
    • Burbank, California, United States, 91506
      • Lovelace Scientific Resources, Inc.
    • Inglewood, California, United States, 90301
      • Chrishard Medical Group
    • Los Angeles, California, United States, 90036
      • Impact Clinical Trials and Powerplay
    • Newport Beach, California, United States, 92660
      • Newport Beach Clinical Research Associates, Inc.
    • San Diego, California, United States, 92128
      • San Diego Managed Care Group
    • Santa Ana, California, United States, 92701
      • Crest Clinical Trials, Inc.
    • Santa Barbara, California, United States, 93108
      • Santa Barbara Clinical Research Inc.
  • Colorado
    • Colorado Springs, Colorado, United States, 80904
      • Clinicos, LLC
    • Denver, Colorado, United States, 80220
      • Horizons Clinical Research Center, LLC
  • Florida
    • Clearwater, Florida, United States, 33761
      • Tampa Bay Medical Research
    • Daytona Beach, Florida, United States, 32114
      • Atlantic Institute of Clinical Research
    • Gainesville, Florida, United States, 32605
      • Florida Research Network, LLC
    • Hollywood, Florida, United States, 33021
      • Orthopaedic Assoc. of S. Broward, P.A.
    • Kissimmee, Florida, United States, 34741
      • FPA Clinical Research
    • Lakeland, Florida, United States, 33805
      • Jay Care Medical Center
    • Largo, Florida, United States, 33770
      • Innovative Research of West FL, Inc.
    • Melbourne, Florida, United States, 32901
      • Oslar Medical, Inc./ Osler Clinical Research
    • Naranja, Florida, United States, 33032
      • Homestead Clinical Research
    • Pembroke Pines, Florida, United States, 33026
      • Andres Patron, DO, PA
    • St. Cloud, Florida, United States, 34769
      • Wilker/Powers Center for Clinical Studies
    • Tampa, Florida, United States, 33607
      • Orlando Rangel, M.D., P.A.
    • Tampa, Florida, United States, 33607
      • West Wind'r Research & Development, LLC
    • West Palm Beach, Florida, United States, 33409
      • Palm Beach Research Center
  • Georgia
    • Atlanta, Georgia, United States, 30312
      • PMI Health Research Group
    • Atlanta, Georgia, United States, 30338
      • Perimeter Institute for Clinical Research, Inc.
    • Decatur, Georgia, United States, 30034
      • Best Clinical Research
  • Illinois
    • Naperville, Illinois, United States, 60564
      • DuPage Family Medicine
  • Kansas
    • Wichita, Kansas, United States, 67205
      • Heartland Research Associates, LLC
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • Central Kentucky Research Associates, Inc.
    • Lexington, Kentucky, United States, 40509
      • Bluegrass Orthopaedics & Hand Care Research
  • Louisiana
    • New Orleans, Louisiana, United States, 70128
      • Clinical Research Institute
    • Shreveport, Louisiana, United States, 71105
      • Highland Clinic, APMC
  • Michigan
    • Waterford, Michigan, United States, 48328
      • Waterford Medical Associates
  • Mississippi
    • Jackson, Mississippi, United States, 39202
      • CRC of Jackson
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Quality Clinical Research, Inc.
    • Omaha, Nebraska, United States, 68144
      • Dr. Meera Dewan PC
  • Nevada
    • Las Vegas, Nevada, United States, 89101
      • Association Of International Professionals
    • Las Vegas, Nevada, United States, 89106
      • ICT - Las Vegas
  • New Jersey
    • Bloomfield, New Jersey, United States, 07003
      • Immedicenter
    • West Caldwell, New Jersey, United States, 07006
      • Land Clinical Studies
  • New York
    • New York, New York, United States, 10022
      • Research Across America
  • North Dakota
    • Fargo, North Dakota, United States, 58104
      • Odyssey Research
  • Ohio
    • Columbus, Ohio, United States, 43207
      • Parsons Avenue Medical Clinic
    • Dayton, Ohio, United States, 45406
      • Dayton Clinical Research
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73119
      • Hillcrest Clinical Research
  • Pennsylvania
    • Harleysville, Pennsylvania, United States, 19438
      • Harleysville Medical Associates
    • Warminster, Pennsylvania, United States, 18974
      • Warminster Medical Association
  • South Carolina
    • Greer, South Carolina, United States, 29651
      • DeGarmo Institute of Medical Research
    • Pelzer, South Carolina, United States, 29669
      • Palmetto Family Medicine Center
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
      • Holston Medical Group, P.C.
  • Texas
    • Arlington, Texas, United States, 76012
      • Medical Clinic of North Texas
    • Austin, Texas, United States, 78705
      • Central Texas Clinical Research
    • Bryan, Texas, United States, 77802
      • DiscoveResearch, Inc.
    • Colleyville, Texas, United States, 76034
      • Texas Family Care Clinical Research
    • Dallas, Texas, United States, 75234
      • Research Across America
    • Georgetown, Texas, United States, 78626
      • Georgetown Medical Clinic
    • Houston, Texas, United States, 77024
      • F. Adam Kawley, MD PA
    • New Braunfels, Texas, United States, 78130
      • Central Texas Health Research
    • San Antonio, Texas, United States, 78215
      • Sun Research Institute
    • San Antonio, Texas, United States, 78229
      • Sylvana Research Associates
    • San Antonio, Texas, United States, 78213
      • Gsa Research
    • Sugar Land, Texas, United States, 77479
      • Clinical Health Research, LLC
  • Virginia
    • Weber City, Virginia, United States, 24290
      • Holston Medical Group, P.C.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 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 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; placebo tablet; Other Names: no other name
Experimental: Carisprodol SR 700 mg; Carisoprodol 700 mg twice daily	Drug: Carisoprodol SR 700 mg; 700 mg twice daily tablet; Other Names: no other name
Experimental: Carisoprodol SR 500mg; Carisoprodol SR 500 mg twice daily	Drug: Carisoprodol SR 500 mg; carisoprodol SR 500 mg tablet; Other Names: no other name

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject Rated Change Relief From Starting Backache of Pain on a 100-point Visual Analog Scale	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.	baseline to 14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject Functional Assessment Based on the Roland-Morris Disability Questionnaire (RMDQ)	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.	baseline and day +14

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: May 1, 2008
• First Submitted That Met QC Criteria: May 2, 2008
• First Posted (Estimate): May 5, 2008

Study Record Updates

• Last Update Posted (Estimate): November 21, 2012
• Last Update Submitted That Met QC Criteria: October 22, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Physiological Effects of Drugs; Peripheral Nervous System Agents; Neuromuscular Agents; Muscle Relaxants, Central; Carisoprodol
• Other Study ID Numbers: MP511

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No