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A 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
Carisoprodol SR
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 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

Sites / Locations

  • MedSearch, LLC
  • Genesis Clinical Research Corporation
  • Vaughn H. Mancha, Jr., PC Family Practice
  • Anasazi Internal Medicine PC
  • Heritage Physician Group
  • OrthoArkansas
  • Family Practice Clinic
  • Quality of Life Medical Center, LLC
  • Trinity Health and Wellness
  • San Diego Sports Medicine & Family Health Center
  • Quality Care Medical Center, Inc.
  • Anthony Roselli, MD
  • Clinical Research of South Florida
  • Southeastern Integrated Medical, PL dba Florida Medical Research Institute
  • South Florida Clinical Research Center
  • FPA Clinical Research
  • Genesis Research International
  • Well Pharma Medical Research Corporation
  • International Research Associates, LLC
  • Tukoi Clinical Research
  • Renstar Medical Research
  • University Clinical Research, Inc.
  • Sunrise Medical Research #501
  • Southwest Florida Clinical Research Center
  • Palm Beach Research Center
  • Perimeter Institute for Clinical Research, Inc.
  • Sunset Medical Research
  • Clinical Pharmacology Study Group
  • Northern Pines Health Center
  • KMED Research
  • Harris & Associates, P.C.
  • Valley Medical Center
  • Westside Family Medical Center, P.C.
  • Kansas City University of Medicine and BioSciences Dybedal Building
  • Comprehensive Clinical Research
  • South Jersey Medical Associations, PA
  • Care Center of Family Practice & Pediatrics of Hamilton
  • Partners in Primary Care
  • Albuquerque Clinical Trials, Inc.
  • Metrolina Medical Research
  • Clinical Research Source Inc.
  • Family Practice Center of Wadsworth, Inc.
  • Integrated Medical Research
  • Williamette Valley Clinical Studies
  • Fanno Creek Clinic, LLC
  • Best Clinical Research - PA
  • Arcuri Clinical Research
  • Partners in Clinical Research
  • Omega Medical Research
  • Robert S. Eagerton Jr., MD Family Practice
  • Holston Medical Group, P.C.
  • ACRC Trials
  • Arlington Family Health Pavilion
  • Central TX Clinical Research
  • Mid-Cities Family Care
  • Evergreen Clinical Research, LLC
  • Deer Park Family Clinic, P.A.
  • Prime Care Medical Group
  • West Houston Clinical Research
  • North Hills Family Practice
  • North Texas Family Medicine
  • Sun Research Institute
  • Unlimited Research
  • InVisions Consultants, LLC
  • Oakwell Clinical Research
  • Health Research of Hampton Roads, Inc.
  • Medical Research Initiatives
  • Liberty Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Carisoprodol 700mg

Carisoprodol 500mg

Placebo

Arm Description

tablet sustained release (SR)

sustained release(SR) tablet

tablet

Outcomes

Primary Outcome Measures

Subject Rating of Pain on a 100-point Visual Analog Scale (VAS)
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

Secondary Outcome Measures

Subject Functional Assessment Based on the Roland-Morris Disability Questionnaire (RMDQ)
Adverse Event Assessment
the number of adverse events reported during the course of the study as reported by the participants

Full Information

First Posted
May 1, 2008
Last Updated
October 4, 2011
Sponsor
Meda Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00671502
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 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 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.

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
840 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Carisoprodol 700mg
Arm Type
Experimental
Arm Description
tablet sustained release (SR)
Arm Title
Carisoprodol 500mg
Arm Type
Experimental
Arm Description
sustained release(SR) tablet
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
tablet
Intervention Type
Drug
Intervention Name(s)
Carisoprodol SR
Other Intervention Name(s)
sustained release(SR)
Intervention Description
700 mg twice daily
Intervention Type
Drug
Intervention Name(s)
Carisoprodol SR
Other Intervention Name(s)
sustained release(SR) tablet
Intervention Description
500 mg twice daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
no other name
Intervention Description
Placebo tablet
Primary Outcome Measure Information:
Title
Subject Rating of Pain on a 100-point Visual Analog Scale (VAS)
Description
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
Time Frame
up to 14 days
Secondary Outcome Measure Information:
Title
Subject Functional Assessment Based on the Roland-Morris Disability Questionnaire (RMDQ)
Time Frame
up to 14 days
Title
Adverse Event Assessment
Description
the number of adverse events reported during the course of the study as reported by the participants
Time Frame
up to 21 days

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

12. IPD Sharing Statement

Learn more about this trial

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

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