Clinical trial NCT00671879: Study to Evaluate Two Formulations of Carisoprodol in Subjects With Musculoskeletal Spasm of the Lower Back
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lower Back Pain
Lead sponsor: Meda Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-05-05
Enrollment: 830
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Subject Rated Change Relief From Starting Backache of Pain on a 100-point Visual Analog Scale
timeFrame: baseline to 14 days
Secondary outcomes:
measure: Subject Functional Assessment Based on the Roland-Morris Disability Questionnaire (RMDQ)
timeFrame: baseline and day +14
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Brookwood Internists, P.C.
state: Alabama
city: Gulf Shores
country: United States
facility: Gulf Shores General Practice Center
state: Alabama
city: Hueytown
country: United States
facility: Simon Williamson Clinic, PC
state: Alabama
city: Montgomery
country: United States
facility: Vaugh H Mancha Jr., PC Family Practice
state: Alabama
city: Phoenix
country: United States
facility: NextCare Institute for Clinical Research
state: Arizona
city: Phoenix
country: United States
facility: HOPE Research Institute
state: Arizona
city: Tempe
country: United States
facility: Fiel Family and Sports Medicine
state: Arizona
city: Little Rock
country: United States
facility: Lynn Institute of the Ozarks
state: Arkansas
city: Anaheim
country: United States
facility: Quality of life Medical, LLC
state: California
city: Beverly Hills
country: United States
facility: ICT - Beverly Hills
state: California
city: Burbank
country: United States
facility: Lovelace Scientific Resources, Inc.
state: California
city: Inglewood
country: United States
facility: Chrishard Medical Group
state: California
city: Los Angeles
country: United States
facility: Impact Clinical Trials and Powerplay
state: California
city: Newport Beach
country: United States
facility: Newport Beach Clinical Research Associates, Inc.
state: California
city: San Diego
country: United States
facility: San Diego Managed Care Group
state: California
city: Santa Ana
country: United States
facility: Crest Clinical Trials, Inc.
state: California
city: Santa Barbara
country: United States
facility: Santa Barbara Clinical Research Inc.
state: California
city: Colorado Springs
country: United States
facility: Clinicos, LLC
state: Colorado
city: Denver
country: United States
facility: Horizons Clinical Research Center, LLC
state: Colorado
city: Clearwater
country: United States
facility: Tampa Bay Medical Research
state: Florida
city: Daytona Beach
country: United States
facility: Atlantic Institute of Clinical Research
state: Florida
city: Gainesville
country: United States
facility: Florida Research Network, LLC
state: Florida
city: Hollywood
country: United States
facility: Orthopaedic Assoc. of S. Broward, P.A.
state: Florida
city: Kissimmee
country: United States
facility: FPA Clinical Research
state: Florida
city: Lakeland
country: United States
facility: Jay Care Medical Center
state: Florida
city: Largo
country: United States
facility: Innovative Research of West FL, Inc.
state: Florida
city: Melbourne
country: United States
facility: Oslar Medical, Inc./ Osler Clinical Research
state: Florida
city: Naranja
country: United States
facility: Homestead Clinical Research
state: Florida
city: Pembroke Pines
country: United States
facility: Andres Patron, DO, PA
state: Florida
city: St. Cloud
country: United States
facility: Wilker/Powers Center for Clinical Studies
state: Florida
city: Tampa
country: United States
facility: Orlando Rangel, M.D., P.A.
state: Florida
city: Tampa
country: United States
facility: West Wind'r Research & Development, LLC
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research center
state: Florida
city: Atlanta
country: United States
facility: PMI Health Research Group
state: Georgia
city: Atlanta
country: United States
facility: Perimeter Institute for Clinical Research, Inc.
state: Georgia
city: Decatur
country: United States
facility: Best Clinical Research
state: Georgia
city: Naperville
country: United States
facility: Dupage Family Medicine
state: Illinois
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Lexington
country: United States
facility: Bluegrass Orthopaedics & Hand Care Research
state: Kentucky
city: Lexington
country: United States
facility: Central Kentucky Research Associates, Inc.
state: Kentucky
city: New Orleans
country: United States
facility: Clinical Research Institute
state: Louisiana
city: Shreveport
country: United States
facility: Highland Clinic, APMC
state: Louisiana
city: Waterford
country: United States
facility: Waterford Medical Associates
state: Michigan
city: Jackson
country: United States
facility: CRC of Jackson
state: Mississippi
city: Omaha
country: United States
facility: Quality Clinical Research, Inc.
state: Nebraska
city: Omaha
country: United States
facility: Dr. Meera Dewan PC
state: Nebraska
city: Las Vegas
country: United States
facility: Association of International Professionals
state: Nevada
city: Las Vegas
country: United States
facility: ICT - Las Vegas
state: Nevada
city: Bloomfield
country: United States
facility: Immedicenter
state: New Jersey
city: West Caldwell
country: United States
facility: Land Clinical Studies
state: New Jersey
city: New York
country: United States
facility: Research Across America
state: New York
city: Fargo
country: United States
facility: Odyssey Research
state: North Dakota
city: Columbus
country: United States
facility: Parsons Avenue Medical Clinic
state: Ohio
city: Dayton
country: United States
facility: Dayton Clinical Research
state: Ohio
city: Oklahoma City
country: United States
facility: Hillcrest Clinical Research
state: Oklahoma
city: Harleysville
country: United States
facility: Harleysville Medical Associates
state: Pennsylvania
city: Warminster
country: United States
facility: Warminster Medical Association
state: Pennsylvania
city: Greer
country: United States
facility: DeGarmo Institute of Medical Research
state: South Carolina
city: Pelzer
country: United States
facility: Palmetto Family Medicine Center
state: South Carolina
city: Kingsport
country: United States
facility: Holston Medical Group, P.C.
state: Tennessee
city: Arlington
country: United States
facility: Medical Clinic of North Texas
state: Texas
city: Austin
country: United States
facility: Central Texas Clinical Research
state: Texas
city: Bryan
country: United States
facility: DiscoveResearch, Inc.
state: Texas
city: Colleyville
country: United States
facility: Texas Family Care Clinical Research
state: Texas
city: Dallas
country: United States
facility: Research Across America
state: Texas
city: Georgetown
country: United States
facility: Georgetown Medical Clinic
state: Texas
city: Houston
country: United States
facility: F. Adam Kawley, MD PA
state: Texas
city: New Braunfels
country: United States
facility: Central Texas Health Research
state: Texas
city: San Antonio
country: United States
facility: GSA Research
state: Texas
city: San Antonio
country: United States
facility: Sun Research Institute
state: Texas
city: San Antonio
country: United States
facility: Sylvana Research Associates
state: Texas
city: Sugar Land
country: United States
facility: Clinical Health Research, LLC
state: Texas
city: Weber City
country: United States
facility: Holston Medical Group, P.C.
state: Virginia
Study officials:
affiliation: Meda Pharmaceuticals
name: Lewis M. Fredane, MD
role: STUDY_DIRECTOR
References: