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Lower Back PainPhase 3NCT00671879

Study to Evaluate Two Formulations of Carisoprodol in Subjects With Musculoskeletal Spasm of the Lower Back

A Phase 3 study testing Carisoprodol SR 700 mg and Carisoprodol SR 500 mg in people with Lower Back Pain, run by Meda Pharmaceuticals at 73 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Lower Back Pain
What is being tested?
Carisoprodol SR 700 mg and Carisoprodol SR 500 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
830 participants
Where
73 sitesUnited States
Study dates
Apr 2008to Mar 2009
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 20Show fewer
  • 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

Trial locations and contacts

73 sites in 1 country.

73 sites in 1 country

United States73 sites

  • Quality of life Medical, LLC

    Anaheim, California, 92801

  • Medical Clinic of North Texas

    Arlington, Texas, 76012

  • PMI Health Research Group

    Atlanta, Georgia, 30312

  • Perimeter Institute for Clinical Research, Inc.

    Atlanta, Georgia, 30338

  • Central Texas Clinical Research

    Austin, Texas, 78705

  • ICT - Beverly Hills

    Beverly Hills, California, 90211

  • Brookwood Internists, P.C.

    Birmingham, Alabama, 35209

  • Immedicenter

    Bloomfield, New Jersey, 07003

  • DiscoveResearch, Inc.

    Bryan, Texas, 77802

  • Lovelace Scientific Resources, Inc.

    Burbank, California, 91506

  • Tampa Bay Medical Research

    Clearwater, Florida, 33761

  • Texas Family Care Clinical Research

    Colleyville, Texas, 76034

  • Clinicos, LLC

    Colorado Springs, Colorado, 80904

  • Parsons Avenue Medical Clinic

    Columbus, Ohio, 43207

  • Research Across America

    Dallas, Texas, 75234

  • Dayton Clinical Research

    Dayton, Ohio, 45406

  • Atlantic Institute of Clinical Research

    Daytona Beach, Florida, 32114

  • Best Clinical Research

    Decatur, Georgia, 30034

  • Horizons Clinical Research Center, LLC

    Denver, Colorado, 80220

  • Odyssey Research

    Fargo, North Dakota, 58104

  • Florida Research Network, LLC

    Gainesville, Florida, 32605

  • Georgetown Medical Clinic

    Georgetown, Texas, 78626

  • DeGarmo Institute of Medical Research

    Greer, South Carolina, 29651

  • Gulf Shores General Practice Center

    Gulf Shores, Alabama, 36547

  • Harleysville Medical Associates

    Harleysville, Pennsylvania, 19438

  • Orthopaedic Assoc. of S. Broward, P.A.

    Hollywood, Florida, 33021

  • F. Adam Kawley, MD PA

    Houston, Texas, 77024

  • Simon Williamson Clinic, PC

    Hueytown, Alabama, 35023

  • Chrishard Medical Group

    Inglewood, California, 90301

  • CRC of Jackson

    Jackson, Mississippi, 39202

  • Holston Medical Group, P.C.

    Kingsport, Tennessee, 37660

  • FPA Clinical Research

    Kissimmee, Florida, 34741

  • Jay Care Medical Center

    Lakeland, Florida, 33805

  • Innovative Research of West FL, Inc.

    Largo, Florida, 33770

  • Association of International Professionals

    Las Vegas, Nevada, 89101

  • ICT - Las Vegas

    Las Vegas, Nevada, 89106

  • Bluegrass Orthopaedics & Hand Care Research

    Lexington, Kentucky, 40509

  • Central Kentucky Research Associates, Inc.

    Lexington, Kentucky, 40509

  • Lynn Institute of the Ozarks

    Little Rock, Arkansas, 72205

  • Impact Clinical Trials and Powerplay

    Los Angeles, California, 90036

  • Oslar Medical, Inc./ Osler Clinical Research

    Melbourne, Florida, 32901

  • Vaugh H Mancha Jr., PC Family Practice

    Montgomery, Alabama, 36117

  • Dupage Family Medicine

    Naperville, Illinois, 60564

  • Homestead Clinical Research

    Naranja, Florida, 33032

  • Central Texas Health Research

    New Braunfels, Texas, 78130

  • Clinical Research Institute

    New Orleans, Louisiana, 70128

  • Research Across America

    New York, New York, 10022

  • Newport Beach Clinical Research Associates, Inc.

    Newport Beach, California, 92660

  • Hillcrest Clinical Research

    Oklahoma City, Oklahoma, 73119

  • Quality Clinical Research, Inc.

    Omaha, Nebraska, 68114

  • Dr. Meera Dewan PC

    Omaha, Nebraska, 68144

  • Palmetto Family Medicine Center

    Pelzer, South Carolina, 29669

  • Andres Patron, DO, PA

    Pembroke Pines, Florida, 33026

  • NextCare Institute for Clinical Research

    Phoenix, Arizona, 85016

  • HOPE Research Institute

    Phoenix, Arizona, 85050

  • Wilker/Powers Center for Clinical Studies

    Saint Cloud, Florida, 34769

  • GSA Research

    San Antonio, Texas, 78213

  • Sun Research Institute

    San Antonio, Texas, 78215

  • Sylvana Research Associates

    San Antonio, Texas, 78229

  • San Diego Managed Care Group

    San Diego, California, 92128

  • Crest Clinical Trials, Inc.

    Santa Ana, California, 92701

  • Santa Barbara Clinical Research Inc.

    Santa Barbara, California, 93108

  • Highland Clinic, APMC

    Shreveport, Louisiana, 71105

  • Clinical Health Research, LLC

    Sugar Land, Texas, 77479

  • Orlando Rangel, M.D., P.A.

    Tampa, Florida, 33607

  • West Wind'r Research & Development, LLC

    Tampa, Florida, 33607

  • Fiel Family and Sports Medicine

    Tempe, Arizona, 85283

  • Warminster Medical Association

    Warminster, Pennsylvania, 18974

  • Waterford Medical Associates

    Waterford, Michigan, 48328

  • Holston Medical Group, P.C.

    Weber City, Virginia, 24290

  • Land Clinical Studies

    West Caldwell, New Jersey, 07006

  • Palm Beach Research center

    West Palm Beach, Florida, 33409

  • Heartland Research Associates, LLC

    Wichita, Kansas, 67205

Other trials in United States

About this study

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

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

Read the 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.

Conditions
Lower Back Pain
Being tested
Carisoprodol SR 700 mg, Carisoprodol SR 500 mg, Placebo
Medical subject headings
Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Carisoprodol SR 700 mgDrug

    Also called no other name

    700 mg twice daily tablet

  • Carisoprodol SR 500 mgDrug

    Also called no other name

    carisoprodol SR 500 mg tablet

  • PlaceboDrug

    Also called no other name

    placebo tablet

Study groups in NCT00671879
Study groupRoleWhat they receive
Carisprodol SR 700 mgExperimentalCarisoprodol 700 mg twice daily
Receives: Drug: Carisoprodol SR 700 mg
Carisoprodol SR 500mgExperimentalCarisoprodol SR 500 mg twice daily
Receives: Drug: Carisoprodol SR 500 mg
PlaceboPlacebo comparatorPlacebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: baseline to 14 days

Secondary outcomes (1)

  1. 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.

    Measured: baseline and day +14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2008 (estimated)
  2. Study startApr 2008
  3. Primary completionMar 2009
  4. Study completionMar 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
830 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00671879
Sponsor's protocol ID
MP511
Status last verified
Oct 2012
First submitted
1 May 2008
Last updated
21 Nov 2012
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Carisoprodol SR 700 mg and Carisoprodol SR 500 mg in people with Lower Back Pain, run by Meda Pharmaceuticals at 73 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 73 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subject Rated Change Relief From Starting Backache of Pain on a 100-point Visual Analog Scale (time frame: baseline to 14 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00671879.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2012.

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