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: NCT00671879
• Other study ID #: MP511
• Status: Completed
• Phase: Phase 3
• First received: May 1, 2008
• Last updated: October 22, 2012
• Start date: April 2008
• Est. completion date: March 2009

Study information

• Verified date: October 2012
• 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 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 information / eligibility

• Status: Completed
• Enrollment: 830
• Est. completion date: March 2009
• Est. primary completion date: March 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 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

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
700 mg twice daily tablet
• Carisoprodol SR 500 mg
carisoprodol SR 500 mg tablet
• Placebo
placebo tablet

Locations

Country	Name	City	State
United States	Quality of life Medical, LLC	Anaheim	California
United States	Medical Clinic of North Texas	Arlington	Texas
United States	Perimeter Institute for Clinical Research, Inc.	Atlanta	Georgia
United States	PMI Health Research Group	Atlanta	Georgia
United States	Central Texas Clinical Research	Austin	Texas
United States	ICT - Beverly Hills	Beverly Hills	California
United States	Brookwood Internists, P.C.	Birmingham	Alabama
United States	Immedicenter	Bloomfield	New Jersey
United States	DiscoveResearch, Inc.	Bryan	Texas
United States	Lovelace Scientific Resources, Inc.	Burbank	California
United States	Tampa Bay Medical Research	Clearwater	Florida
United States	Texas Family Care Clinical Research	Colleyville	Texas
United States	Clinicos, LLC	Colorado Springs	Colorado
United States	Parsons Avenue Medical Clinic	Columbus	Ohio
United States	Research Across America	Dallas	Texas
United States	Dayton Clinical Research	Dayton	Ohio
United States	Atlantic Institute of Clinical Research	Daytona Beach	Florida
United States	Best Clinical Research	Decatur	Georgia
United States	Horizons Clinical Research Center, LLC	Denver	Colorado
United States	Odyssey Research	Fargo	North Dakota
United States	Florida Research Network, LLC	Gainesville	Florida
United States	Georgetown Medical Clinic	Georgetown	Texas
United States	DeGarmo Institute of Medical Research	Greer	South Carolina
United States	Gulf Shores General Practice Center	Gulf Shores	Alabama
United States	Harleysville Medical Associates	Harleysville	Pennsylvania
United States	Orthopaedic Assoc. of S. Broward, P.A.	Hollywood	Florida
United States	F. Adam Kawley, MD PA	Houston	Texas
United States	Simon Williamson Clinic, PC	Hueytown	Alabama
United States	Chrishard Medical Group	Inglewood	California
United States	CRC of Jackson	Jackson	Mississippi
United States	Holston Medical Group, P.C.	Kingsport	Tennessee
United States	FPA Clinical Research	Kissimmee	Florida
United States	Jay Care Medical Center	Lakeland	Florida
United States	Innovative Research of West FL, Inc.	Largo	Florida
United States	Association of International Professionals	Las Vegas	Nevada
United States	ICT - Las Vegas	Las Vegas	Nevada
United States	Bluegrass Orthopaedics & Hand Care Research	Lexington	Kentucky
United States	Central Kentucky Research Associates, Inc.	Lexington	Kentucky
United States	Lynn Institute of the Ozarks	Little Rock	Arkansas
United States	Impact Clinical Trials and Powerplay	Los Angeles	California
United States	Oslar Medical, Inc./ Osler Clinical Research	Melbourne	Florida
United States	Vaugh H Mancha Jr., PC Family Practice	Montgomery	Alabama
United States	Dupage Family Medicine	Naperville	Illinois
United States	Homestead Clinical Research	Naranja	Florida
United States	Central Texas Health Research	New Braunfels	Texas
United States	Clinical Research Institute	New Orleans	Louisiana
United States	Research Across America	New York	New York
United States	Newport Beach Clinical Research Associates, Inc.	Newport Beach	California
United States	Hillcrest Clinical Research	Oklahoma City	Oklahoma
United States	Dr. Meera Dewan PC	Omaha	Nebraska
United States	Quality Clinical Research, Inc.	Omaha	Nebraska
United States	Palmetto Family Medicine Center	Pelzer	South Carolina
United States	Andres Patron, DO, PA	Pembroke Pines	Florida
United States	HOPE Research Institute	Phoenix	Arizona
United States	NextCare Institute for Clinical Research	Phoenix	Arizona
United States	GSA Research	San Antonio	Texas
United States	Sun Research Institute	San Antonio	Texas
United States	Sylvana Research Associates	San Antonio	Texas
United States	San Diego Managed Care Group	San Diego	California
United States	Crest Clinical Trials, Inc.	Santa Ana	California
United States	Santa Barbara Clinical Research Inc.	Santa Barbara	California
United States	Highland Clinic, APMC	Shreveport	Louisiana
United States	Wilker/Powers Center for Clinical Studies	St. Cloud	Florida
United States	Clinical Health Research, LLC	Sugar Land	Texas
United States	Orlando Rangel, M.D., P.A.	Tampa	Florida
United States	West Wind'r Research & Development, LLC	Tampa	Florida
United States	Fiel Family and Sports Medicine	Tempe	Arizona
United States	Warminster Medical Association	Warminster	Pennsylvania
United States	Waterford Medical Associates	Waterford	Michigan
United States	Holston Medical Group, P.C.	Weber City	Virginia
United States	Land Clinical Studies	West Caldwell	New Jersey
United States	Palm Beach Research center	West Palm Beach	Florida
United States	Heartland Research Associates, LLC	Wichita	Kansas

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 Rated Change Relief From Starting Backache of Pain on a 100-point Visual Analog Scale	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.	baseline to 14 days	No
Secondary	Subject Functional Assessment Based on the Roland-Morris Disability Questionnaire (RMDQ)	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.	baseline and day +14	No