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 700 mg
Drug: Carisoprodol SR 500 mg
Drug: Placebo

Registration Number: NCT00671879

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 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 830

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Carisprodol SR 700 mg	Carisoprodol SR 700 mg	Carisoprodol 700 mg twice daily
Carisoprodol SR 500mg	Carisoprodol SR 500 mg	Carisoprodol SR 500 mg twice daily
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Subject Rated Change Relief From Starting Backache of Pain on a 100-point Visual Analog Scale	baseline to 14 days	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

Name	Time	Method
Subject Functional Assessment Based on the Roland-Morris Disability Questionnaire (RMDQ)	baseline and day +14	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.

Trial Locations

Locations (71): Brookwood Internists, P.C.
🇺🇸
Birmingham, Alabama, United States
Gulf Shores General Practice Center
🇺🇸
Gulf Shores, Alabama, United States
Simon Williamson Clinic, PC
🇺🇸
Hueytown, Alabama, United States
Vaugh H Mancha Jr., PC Family Practice
🇺🇸
Montgomery, Alabama, United States
NextCare Institute for Clinical Research
🇺🇸
Phoenix, Arizona, United States
HOPE Research Institute
🇺🇸
Phoenix, Arizona, United States
Fiel Family and Sports Medicine
🇺🇸
Tempe, Arizona, United States
Lynn Institute of the Ozarks
🇺🇸
Little Rock, Arkansas, United States
Quality of life Medical, LLC
🇺🇸
Anaheim, California, United States
ICT - Beverly Hills
🇺🇸
Beverly Hills, California, United States
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Brookwood Internists, P.C.
🇺🇸Birmingham, Alabama, United States