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

Phase 3

Completed

• Conditions: Lower Back Pain
• Interventions: Drug: Carisoprodol SR; Drug: Placebo

• Registration Number: NCT00671502
• Lead Sponsor: Meda Pharmaceuticals

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.

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-05-01
• Study First Submitted QC: 2008-05-01
• Study First Posted: 2008-05-05
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Results First Submitted: 2011-06-28
• Status Verified: 2011-10
• Results First Submitted QC: 2011-10-04
• Last Update Submitted: 2011-10-04
• Results First Posted: 2011-11-09
• Last Update Posted: 2011-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 840

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Carisoprodol 500mg	Carisoprodol SR	sustained release(SR) tablet
Carisoprodol 700mg	Carisoprodol SR	tablet sustained release (SR)
Placebo	Placebo	tablet

Primary Outcome Measures

Name	Time	Method
Subject Rating of Pain on a 100-point Visual Analog Scale (VAS)	up to 14 days	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

Name	Time	Method
Subject Functional Assessment Based on the Roland-Morris Disability Questionnaire (RMDQ)	up to 14 days
Adverse Event Assessment	up to 21 days	the number of adverse events reported during the course of the study as reported by the participants

Trial Locations

Locations (68)

MedSearch, LLC; 🇺🇸 Birmingham, Alabama, United States

Genesis Clinical Research Corporation; 🇺🇸 Huntsville, Alabama, United States

Vaughn H. Mancha, Jr., PC Family Practice; 🇺🇸 Montgomery, Alabama, United States

Anasazi Internal Medicine PC; 🇺🇸 Phoenix, Arizona, United States

Heritage Physician Group; 🇺🇸 Hot Springs, Arkansas, United States

OrthoArkansas; 🇺🇸 Little Rock, Arkansas, United States

Family Practice Clinic; 🇺🇸 North Little Rock, Arkansas, United States

Quality of Life Medical Center, LLC; 🇺🇸 Hawaiian Gardens, California, United States

Trinity Health and Wellness; 🇺🇸 Roseville, California, United States

San Diego Sports Medicine & Family Health Center; 🇺🇸 San Diego, California, United States

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