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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00671502
Other study ID # MP510
Secondary ID
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


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
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