Study to Evaluate Two Formulations of Carisoprodol in Subjects With Musculoskeletal Spasm of the Lower Back - Full Text View

Purpose

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

Condition	Intervention	Phase
Lower Back Pain	Drug: Carisoprodol SR 700 mg Drug: Carisoprodol SR 500 mg Drug: Placebo	Phase 3

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

Resource links provided by NLM:

MedlinePlus related topics: Back Pain

Drug Information available for: Carisoprodol

U.S. FDA Resources

Further study details as provided by Meda Pharmaceuticals:

Primary Outcome Measures:

Subject Rated Change Relief From Starting Backache of Pain on a 100-point Visual Analog Scale [ Time Frame: baseline to 14 days ] [ Designated as safety issue: No ]
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:

Subject Functional Assessment Based on the Roland-Morris Disability Questionnaire (RMDQ) [ Time Frame: baseline and day +14 ] [ Designated as safety issue: No ]
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.

Enrollment:	830
Study Start Date:	April 2008
Study Completion Date:	March 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Carisprodol SR 700 mg Carisoprodol 700 mg twice daily	Drug: Carisoprodol SR 700 mg 700 mg twice daily tablet Other Name: no other name
Experimental: Carisoprodol SR 500mg Carisoprodol SR 500 mg twice daily	Drug: Carisoprodol SR 500 mg carisoprodol SR 500 mg tablet Other Name: no other name
Placebo Comparator: Placebo Placebo	Drug: Placebo placebo tablet Other Name: no other name

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00671879

Show 73 Study Locations

Sponsors and Collaborators

Meda Pharmaceuticals

Investigators

Study Director:

Lewis M. Fredane, MD

Meda Pharmaceuticals

More Information

No publications provided

Responsible Party:	Meda Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00671879 History of Changes
Other Study ID Numbers:	MP511
Study First Received:	May 1, 2008
Results First Received:	July 13, 2011
Last Updated:	October 22, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Carisoprodol

Muscle Relaxants, Central
Physiological Effects of Drugs
Pharmacologic Actions
Neuromuscular Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013