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

Lower Back Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00671502
• Other study ID #: MP510
• Status: Completed
• Phase: Phase 3
• First received: May 1, 2008
• Last updated: October 4, 2011
• Start date: April 2008
• Est. completion date: February 2009

Study information

• Verified date: October 2011
• Source: Meda Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 840
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Low Back Pain
• Lower Back Pain

Intervention

Drug:
• Carisoprodol SR
700 mg twice daily
• Carisoprodol SR
500 mg twice daily
• Placebo
Placebo tablet

Locations

Country	Name	City	State
United States	ACRC Trials	Addison	Texas
United States	Albuquerque Clinical Trials, Inc.	Albuquerque	New Mexico
United States	Arlington Family Health Pavilion	Arlington	Texas
United States	Integrated Medical Research	Ashland	Oregon
United States	Perimeter Institute for Clinical Research, Inc.	Atlanta	Georgia
United States	Central TX Clinical Research	Austin	Texas
United States	Anthony Roselli, MD	Avon	Connecticut
United States	Mid-Cities Family Care	Bedford	Texas
United States	Evergreen Clinical Research, LLC	Bellaire	Texas
United States	Comprehensive Clinical Research	Berlin	New Jersey
United States	MedSearch, LLC	Birmingham	Alabama
United States	South Jersey Medical Associations, PA	Blackwood	New Jersey
United States	Holston Medical Group, P.C.	Bristol	Tennessee
United States	Northern Pines Health Center	Buckley	Michigan
United States	Metrolina Medical Research	Charlotte	North Carolina
United States	KMED Research	Clair Shores	Michigan
United States	Clinical Research of South Florida	Coral Gables	Florida
United States	Partners in Clinical Research	Cumberland	Rhode Island
United States	Deer Park Family Clinic, P.A.	Deer Park	Texas
United States	Harris & Associates, P.C.	Detroit	Michigan
United States	Williamette Valley Clinical Studies	Eugene	Oregon
United States	Valley Medical Center	Flint	Michigan
United States	Southeastern Integrated Medical, PL dba Florida Medical Research Institute	Gainesville	Florida
United States	Care Center of Family Practice & Pediatrics of Hamilton	Hamilton	New Jersey
United States	Quality of Life Medical Center, LLC	Hawaiian Gardens	California
United States	South Florida Clinical Research Center	Hollywood	Florida
United States	Heritage Physician Group	Hot Springs	Arkansas
United States	Prime Care Medical Group	Houston	Texas
United States	West Houston Clinical Research	Houston	Texas
United States	Genesis Clinical Research Corporation	Huntsville	Alabama
United States	Westside Family Medical Center, P.C.	Kalamazoo	Michigan
United States	Kansas City University of Medicine and BioSciences Dybedal Building	Kansas City	Missouri
United States	FPA Clinical Research	Kissimmee	Florida
United States	OrthoArkansas	Little Rock	Arkansas
United States	Genesis Research International	Longwood	Florida
United States	Robert S. Eagerton Jr., MD Family Practice	Manning	South Carolina
United States	International Research Associates, LLC	Miami	Florida
United States	Tukoi Clinical Research	Miami	Florida
United States	Well Pharma Medical Research Corporation	Miami	Florida
United States	Vaughn H. Mancha, Jr., PC Family Practice	Montgomery	Alabama
United States	Health Research of Hampton Roads, Inc.	Newport News	Virginia
United States	Family Practice Clinic	North Little Rock	Arkansas
United States	North Hills Family Practice	North Richland Hills	Texas
United States	Renstar Medical Research	Ocala	Florida
United States	University Clinical Research, Inc.	Pembroke Pines	Florida
United States	Clinical Research Source Inc.	Perrysburg	Ohio
United States	Arcuri Clinical Research	Philadelphia	Pennsylvania
United States	Best Clinical Research - PA	Philadelphia	Pennsylvania
United States	Anasazi Internal Medicine PC	Phoenix	Arizona
United States	North Texas Family Medicine	Plano	Texas
United States	Sunrise Medical Research #501	Plantation	Florida
United States	Fanno Creek Clinic, LLC	Portland	Oregon
United States	Medical Research Initiatives	Richmond	Virginia
United States	Trinity Health and Wellness	Roseville	California
United States	InVisions Consultants, LLC	San Antonio	Texas
United States	Oakwell Clinical Research	San Antonio	Texas
United States	Sun Research Institute	San Antonio	Texas
United States	Unlimited Research	San Antonio	Texas
United States	San Diego Sports Medicine & Family Health Center	San Diego	California
United States	Sunset Medical Research	Sunset	Louisiana
United States	Liberty Research Center	Tacoma	Washington
United States	Southwest Florida Clinical Research Center	Tampa	Florida
United States	Quality Care Medical Center, Inc.	Vista	California
United States	Partners in Primary Care	Voorhees	New Jersey
United States	Family Practice Center of Wadsworth, Inc.	Wadsworth	Ohio
United States	Omega Medical Research	Warwick	Rhode Island
United States	Palm Beach Research Center	West Palm Beach	Florida
United States	Clinical Pharmacology Study Group	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Meda Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	up to 14 days	No
Secondary	Subject Functional Assessment Based on the Roland-Morris Disability Questionnaire (RMDQ)		up to 14 days	No
Secondary	Adverse Event Assessment	the number of adverse events reported during the course of the study as reported by the participants	up to 21 days	Yes