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

Primary Purpose

Lower Back Pain

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Carisoprodol SR 700 mg
Carisoprodol SR 500 mg
Placebo
Sponsored by
Meda Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lower Back Pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Brookwood Internists, P.C.
  • Gulf Shores General Practice Center
  • Simon Williamson Clinic, PC
  • Vaugh H Mancha Jr., PC Family Practice
  • NextCare Institute for Clinical Research
  • HOPE Research Institute
  • Fiel Family and Sports Medicine
  • Lynn Institute of the Ozarks
  • Quality of life Medical, LLC
  • ICT - Beverly Hills
  • Lovelace Scientific Resources, Inc.
  • Chrishard Medical Group
  • Impact Clinical Trials and Powerplay
  • Newport Beach Clinical Research Associates, Inc.
  • San Diego Managed Care Group
  • Crest Clinical Trials, Inc.
  • Santa Barbara Clinical Research Inc.
  • Clinicos, LLC
  • Horizons Clinical Research Center, LLC
  • Tampa Bay Medical Research
  • Atlantic Institute of Clinical Research
  • Florida Research Network, LLC
  • Orthopaedic Assoc. of S. Broward, P.A.
  • FPA Clinical Research
  • Jay Care Medical Center
  • Innovative Research of West FL, Inc.
  • Oslar Medical, Inc./ Osler Clinical Research
  • Homestead Clinical Research
  • Andres Patron, DO, PA
  • Wilker/Powers Center for Clinical Studies
  • Orlando Rangel, M.D., P.A.
  • West Wind'r Research & Development, LLC
  • Palm Beach Research center
  • PMI Health Research Group
  • Perimeter Institute for Clinical Research, Inc.
  • Best Clinical Research
  • Dupage Family Medicine
  • Heartland Research Associates, LLC
  • Bluegrass Orthopaedics & Hand Care Research
  • Central Kentucky Research Associates, Inc.
  • Clinical Research Institute
  • Highland Clinic, APMC
  • Waterford Medical Associates
  • CRC of Jackson
  • Quality Clinical Research, Inc.
  • Dr. Meera Dewan PC
  • Association of International Professionals
  • ICT - Las Vegas
  • Immedicenter
  • Land Clinical Studies
  • Research Across America
  • Odyssey Research
  • Parsons Avenue Medical Clinic
  • Dayton Clinical Research
  • Hillcrest Clinical Research
  • Harleysville Medical Associates
  • Warminster Medical Association
  • DeGarmo Institute of Medical Research
  • Palmetto Family Medicine Center
  • Holston Medical Group, P.C.
  • Medical Clinic of North Texas
  • Central Texas Clinical Research
  • DiscoveResearch, Inc.
  • Texas Family Care Clinical Research
  • Research Across America
  • Georgetown Medical Clinic
  • F. Adam Kawley, MD PA
  • Central Texas Health Research
  • GSA Research
  • Sun Research Institute
  • Sylvana Research Associates
  • Clinical Health Research, LLC
  • Holston Medical Group, P.C.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Carisprodol SR 700 mg

Carisoprodol SR 500mg

Placebo

Arm Description

Carisoprodol 700 mg twice daily

Carisoprodol SR 500 mg twice daily

Placebo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
May 1, 2008
Last Updated
October 22, 2012
Sponsor
Meda Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00671879
Brief Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meda Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
830 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Carisprodol SR 700 mg
Arm Type
Experimental
Arm Description
Carisoprodol 700 mg twice daily
Arm Title
Carisoprodol SR 500mg
Arm Type
Experimental
Arm Description
Carisoprodol SR 500 mg twice daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Carisoprodol SR 700 mg
Other Intervention Name(s)
no other name
Intervention Description
700 mg twice daily tablet
Intervention Type
Drug
Intervention Name(s)
Carisoprodol SR 500 mg
Other Intervention Name(s)
no other name
Intervention Description
carisoprodol SR 500 mg tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
no other name
Intervention Description
placebo tablet
Primary Outcome Measure Information:
Title
Subject Rated Change Relief From Starting Backache of Pain on a 100-point Visual Analog Scale
Description
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.
Time Frame
baseline to 14 days
Secondary Outcome Measure Information:
Title
Subject Functional Assessment Based on the Roland-Morris Disability Questionnaire (RMDQ)
Description
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.
Time Frame
baseline and day +14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lewis M. Fredane, MD
Organizational Affiliation
Meda Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Brookwood Internists, P.C.
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Gulf Shores General Practice Center
City
Gulf Shores
State/Province
Alabama
ZIP/Postal Code
36547
Country
United States
Facility Name
Simon Williamson Clinic, PC
City
Hueytown
State/Province
Alabama
ZIP/Postal Code
35023
Country
United States
Facility Name
Vaugh H Mancha Jr., PC Family Practice
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36117
Country
United States
Facility Name
NextCare Institute for Clinical Research
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
HOPE Research Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85050
Country
United States
Facility Name
Fiel Family and Sports Medicine
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85283
Country
United States
Facility Name
Lynn Institute of the Ozarks
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Quality of life Medical, LLC
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
ICT - Beverly Hills
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Lovelace Scientific Resources, Inc.
City
Burbank
State/Province
California
ZIP/Postal Code
91506
Country
United States
Facility Name
Chrishard Medical Group
City
Inglewood
State/Province
California
ZIP/Postal Code
90301
Country
United States
Facility Name
Impact Clinical Trials and Powerplay
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Newport Beach Clinical Research Associates, Inc.
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
San Diego Managed Care Group
City
San Diego
State/Province
California
ZIP/Postal Code
92128
Country
United States
Facility Name
Crest Clinical Trials, Inc.
City
Santa Ana
State/Province
California
ZIP/Postal Code
92701
Country
United States
Facility Name
Santa Barbara Clinical Research Inc.
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93108
Country
United States
Facility Name
Clinicos, LLC
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80904
Country
United States
Facility Name
Horizons Clinical Research Center, LLC
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Tampa Bay Medical Research
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Facility Name
Atlantic Institute of Clinical Research
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32114
Country
United States
Facility Name
Florida Research Network, LLC
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Facility Name
Orthopaedic Assoc. of S. Broward, P.A.
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
FPA Clinical Research
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Facility Name
Jay Care Medical Center
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Innovative Research of West FL, Inc.
City
Largo
State/Province
Florida
ZIP/Postal Code
33770
Country
United States
Facility Name
Oslar Medical, Inc./ Osler Clinical Research
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Facility Name
Homestead Clinical Research
City
Naranja
State/Province
Florida
ZIP/Postal Code
33032
Country
United States
Facility Name
Andres Patron, DO, PA
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33026
Country
United States
Facility Name
Wilker/Powers Center for Clinical Studies
City
St. Cloud
State/Province
Florida
ZIP/Postal Code
34769
Country
United States
Facility Name
Orlando Rangel, M.D., P.A.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
West Wind'r Research & Development, LLC
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Palm Beach Research center
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
PMI Health Research Group
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30312
Country
United States
Facility Name
Perimeter Institute for Clinical Research, Inc.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30338
Country
United States
Facility Name
Best Clinical Research
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30034
Country
United States
Facility Name
Dupage Family Medicine
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60564
Country
United States
Facility Name
Heartland Research Associates, LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67205
Country
United States
Facility Name
Bluegrass Orthopaedics & Hand Care Research
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
Central Kentucky Research Associates, Inc.
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
Clinical Research Institute
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70128
Country
United States
Facility Name
Highland Clinic, APMC
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105
Country
United States
Facility Name
Waterford Medical Associates
City
Waterford
State/Province
Michigan
ZIP/Postal Code
48328
Country
United States
Facility Name
CRC of Jackson
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
Quality Clinical Research, Inc.
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Dr. Meera Dewan PC
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
Association of International Professionals
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89101
Country
United States
Facility Name
ICT - Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Immedicenter
City
Bloomfield
State/Province
New Jersey
ZIP/Postal Code
07003
Country
United States
Facility Name
Land Clinical Studies
City
West Caldwell
State/Province
New Jersey
ZIP/Postal Code
07006
Country
United States
Facility Name
Research Across America
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
Odyssey Research
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
Facility Name
Parsons Avenue Medical Clinic
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43207
Country
United States
Facility Name
Dayton Clinical Research
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45406
Country
United States
Facility Name
Hillcrest Clinical Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73119
Country
United States
Facility Name
Harleysville Medical Associates
City
Harleysville
State/Province
Pennsylvania
ZIP/Postal Code
19438
Country
United States
Facility Name
Warminster Medical Association
City
Warminster
State/Province
Pennsylvania
ZIP/Postal Code
18974
Country
United States
Facility Name
DeGarmo Institute of Medical Research
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Palmetto Family Medicine Center
City
Pelzer
State/Province
South Carolina
ZIP/Postal Code
29669
Country
United States
Facility Name
Holston Medical Group, P.C.
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Medical Clinic of North Texas
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Central Texas Clinical Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
DiscoveResearch, Inc.
City
Bryan
State/Province
Texas
ZIP/Postal Code
77802
Country
United States
Facility Name
Texas Family Care Clinical Research
City
Colleyville
State/Province
Texas
ZIP/Postal Code
76034
Country
United States
Facility Name
Research Across America
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Facility Name
Georgetown Medical Clinic
City
Georgetown
State/Province
Texas
ZIP/Postal Code
78626
Country
United States
Facility Name
F. Adam Kawley, MD PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Central Texas Health Research
City
New Braunfels
State/Province
Texas
ZIP/Postal Code
78130
Country
United States
Facility Name
GSA Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Facility Name
Sun Research Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Sylvana Research Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Clinical Health Research, LLC
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
Holston Medical Group, P.C.
City
Weber City
State/Province
Virginia
ZIP/Postal Code
24290
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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