Clinical trial NCT00671502: A 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: 840
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 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.

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 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

Primary outcomes:
measure: Subject Rating of Pain on a 100-point Visual Analog Scale (VAS)
timeFrame: up to 14 days
Secondary outcomes:
measure: Subject Functional Assessment Based on the Roland-Morris Disability Questionnaire (RMDQ)
timeFrame: up to 14 days
measure: Adverse Event Assessment
timeFrame: up to 21 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: MedSearch, LLC
state: Alabama
city: Huntsville
country: United States
facility: Genesis Clinical Research Corporation
state: Alabama
city: Montgomery
country: United States
facility: Vaughn H. Mancha, Jr., PC Family Practice
state: Alabama
city: Phoenix
country: United States
facility: Anasazi Internal Medicine PC
state: Arizona
city: Hot Springs
country: United States
facility: Heritage Physician Group
state: Arkansas
city: Little Rock
country: United States
facility: OrthoArkansas
state: Arkansas
city: North Little Rock
country: United States
facility: Family Practice Clinic
state: Arkansas
city: Hawaiian Gardens
country: United States
facility: Quality of Life Medical Center, LLC
state: California
city: Roseville
country: United States
facility: Trinity Health and Wellness
state: California
city: San Diego
country: United States
facility: San Diego Sports Medicine & Family Health Center
state: California
city: Vista
country: United States
facility: Quality Care Medical Center, Inc.
state: California
city: Avon
country: United States
facility: Anthony Roselli, MD
state: Connecticut
city: Coral Gables
country: United States
facility: Clinical Research of South Florida
state: Florida
city: Gainesville
country: United States
facility: Southeastern Integrated Medical, PL dba Florida Medical Research Institute
state: Florida
city: Hollywood
country: United States
facility: South Florida Clinical Research Center
state: Florida
city: Kissimmee
country: United States
facility: FPA Clinical Research
state: Florida
city: Longwood
country: United States
facility: Genesis Research International
state: Florida
city: Miami
country: United States
facility: Well Pharma Medical Research Corporation
state: Florida
city: Miami
country: United States
facility: International Research Associates, LLC
state: Florida
city: Miami
country: United States
facility: Tukoi Clinical Research
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Pembroke Pines
country: United States
facility: University Clinical Research, Inc.
state: Florida
city: Plantation
country: United States
facility: Sunrise Medical Research #501
state: Florida
city: Tampa
country: United States
facility: Southwest Florida Clinical Research Center
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research Center
state: Florida
city: Atlanta
country: United States
facility: Perimeter Institute for Clinical Research, Inc.
state: Georgia
city: Sunset
country: United States
facility: Sunset Medical Research
state: Louisiana
city: Worcester
country: United States
facility: Clinical Pharmacology Study Group
state: Massachusetts
city: Buckley
country: United States
facility: Northern Pines Health Center
state: Michigan
city: Clair Shores
country: United States
facility: KMED Research
state: Michigan
city: Detroit
country: United States
facility: Harris & Associates, P.C.
state: Michigan
city: Flint
country: United States
facility: Valley Medical Center
state: Michigan
city: Kalamazoo
country: United States
facility: Westside Family Medical Center, P.C.
state: Michigan
city: Kansas City
country: United States
facility: Kansas City University of Medicine and BioSciences Dybedal Building
state: Missouri
city: Berlin
country: United States
facility: Comprehensive Clinical Research
state: New Jersey
city: Blackwood
country: United States
facility: South Jersey Medical Associations, PA
state: New Jersey
city: Hamilton
country: United States
facility: Care Center of Family Practice & Pediatrics of Hamilton
state: New Jersey
city: Voorhees
country: United States
facility: Partners in Primary Care
state: New Jersey
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials, Inc.
state: New Mexico
city: Charlotte
country: United States
facility: Metrolina Medical Research
state: North Carolina
city: Perrysburg
country: United States
facility: Clinical Research Source Inc.
state: Ohio
city: Wadsworth
country: United States
facility: Family Practice Center of Wadsworth, Inc.
state: Ohio
city: Ashland
country: United States
facility: Integrated Medical Research
state: Oregon
city: Eugene
country: United States
facility: Williamette Valley Clinical Studies
state: Oregon
city: Portland
country: United States
facility: Fanno Creek Clinic, LLC
state: Oregon
city: Philadelphia
country: United States
facility: Best Clinical Research - PA
state: Pennsylvania
city: Philadelphia
country: United States
facility: Arcuri Clinical Research
state: Pennsylvania
city: Cumberland
country: United States
facility: Partners in Clinical Research
state: Rhode Island
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Manning
country: United States
facility: Robert S. Eagerton Jr., MD Family Practice
state: South Carolina
city: Bristol
country: United States
facility: Holston Medical Group, P.C.
state: Tennessee
city: Addison
country: United States
facility: ACRC Trials
state: Texas
city: Arlington
country: United States
facility: Arlington Family Health Pavilion
state: Texas
city: Austin
country: United States
facility: Central TX Clinical Research
state: Texas
city: Bedford
country: United States
facility: Mid-Cities Family Care
state: Texas
city: Bellaire
country: United States
facility: Evergreen Clinical Research, LLC
state: Texas
city: Deer Park
country: United States
facility: Deer Park Family Clinic, P.A.
state: Texas
city: Houston
country: United States
facility: Prime Care Medical Group
state: Texas
city: Houston
country: United States
facility: West Houston Clinical Research
state: Texas
city: North Richland Hills
country: United States
facility: North Hills Family Practice
state: Texas
city: Plano
country: United States
facility: North Texas Family Medicine
state: Texas
city: San Antonio
country: United States
facility: Sun Research Institute
state: Texas
city: San Antonio
country: United States
facility: Unlimited Research
state: Texas
city: San Antonio
country: United States
facility: InVisions Consultants, LLC
state: Texas
city: San Antonio
country: United States
facility: Oakwell Clinical Research
state: Texas
city: Newport News
country: United States
facility: Health Research of Hampton Roads, Inc.
state: Virginia
city: Richmond
country: United States
facility: Medical Research Initiatives
state: Virginia
city: Tacoma
country: United States
facility: Liberty Research Center
state: Washington
Study officials:
affiliation: Meda Pharmaceuticals
name: Lewis M. Fredane, MD
role: STUDY_DIRECTOR
References: