Lower Back PainPhase 3NCT00671502
A Study to Evaluate Two Formulations of Carisoprodol in Subjects With Musculoskeletal Spasm of the Lower Back
A Phase 3 study testing Carisoprodol SR in people with Lower Back Pain, run by Meda Pharmaceuticals at 68 sites in United States.
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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 840 participants
- Where
- 68 sitesUnited States
- Study dates
- Apr 2008to Feb 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 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
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
68 sites in 1 country.
68 sites in 1 country
United States68 sites
ACRC Trials
Addison, Texas, 75001
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, 87102
Arlington Family Health Pavilion
Arlington, Texas, 76012
Integrated Medical Research
Ashland, Oregon, 97520
Perimeter Institute for Clinical Research, Inc.
Atlanta, Georgia, 30338
Central TX Clinical Research
Austin, Texas, 78705
Anthony Roselli, MD
Avon, Connecticut, 06001
Mid-Cities Family Care
Bedford, Texas, 76021
Evergreen Clinical Research, LLC
Bellaire, Texas, 77401
Comprehensive Clinical Research
Berlin, New Jersey, 08009
MedSearch, LLC
Birmingham, Alabama, 35235
South Jersey Medical Associations, PA
Blackwood, New Jersey, 08012
Holston Medical Group, P.C.
Bristol, Tennessee, 37620
Northern Pines Health Center
Buckley, Michigan, 49620
Metrolina Medical Research
Charlotte, North Carolina, 28209
KMED Research
Clair Shores, Michigan, 48081
Clinical Research of South Florida
Coral Gables, Florida, 33134
Partners in Clinical Research
Cumberland, Rhode Island, 02864
Deer Park Family Clinic, P.A.
Deer Park, Texas, 77536
Harris & Associates, P.C.
Detroit, Michigan, 48235
Williamette Valley Clinical Studies
Eugene, Oregon, 91404
Valley Medical Center
Flint, Michigan, 48507
Southeastern Integrated Medical, PL dba Florida Medical Research Institute
Gainesville, Florida, 32607
Care Center of Family Practice & Pediatrics of Hamilton
Hamilton, New Jersey, 08610
Quality of Life Medical Center, LLC
Hawaiian Gardens, California, 90716
South Florida Clinical Research Center
Hollywood, Florida, 33023
Heritage Physician Group
Hot Springs, Arkansas, 71913
Prime Care Medical Group
Houston, Texas, 77024
West Houston Clinical Research
Houston, Texas, 77055
Genesis Clinical Research Corporation
Huntsville, Alabama, 35802
Westside Family Medical Center, P.C.
Kalamazoo, Michigan, 49009
Kansas City University of Medicine and BioSciences Dybedal Building
Kansas City, Missouri, 64106
FPA Clinical Research
Kissimmee, Florida, 34741
OrthoArkansas
Little Rock, Arkansas, 72205
Genesis Research International
Longwood, Florida, 32779
Robert S. Eagerton Jr., MD Family Practice
Manning, South Carolina, 29102
Well Pharma Medical Research Corporation
Miami, Florida, 33143
International Research Associates, LLC
Miami, Florida, 33156
Tukoi Clinical Research
Miami, Florida, 33180
Vaughn H. Mancha, Jr., PC Family Practice
Montgomery, Alabama, 36117
Health Research of Hampton Roads, Inc.
Newport News, Virginia, 23606
Family Practice Clinic
North Little Rock, Arkansas, 72114
North Hills Family Practice
North Richland Hills, Texas, 76180
Renstar Medical Research
Ocala, Florida, 34471
University Clinical Research, Inc.
Pembroke Pines, Florida, 33024
Clinical Research Source Inc.
Perrysburg, Ohio, 43551
Best Clinical Research - PA
Philadelphia, Pennsylvania, 19104
Arcuri Clinical Research
Philadelphia, Pennsylvania, 19142
Anasazi Internal Medicine PC
Phoenix, Arizona, 85032
North Texas Family Medicine
Plano, Texas, 75093
Sunrise Medical Research #501
Plantation, Florida, 33324
Fanno Creek Clinic, LLC
Portland, Oregon, 97219
Medical Research Initiatives
Richmond, Virginia, 23230
Trinity Health and Wellness
Roseville, California, 95661
Sun Research Institute
San Antonio, Texas, 78205
Unlimited Research
San Antonio, Texas, 78217
InVisions Consultants, LLC
San Antonio, Texas, 78218
Oakwell Clinical Research
San Antonio, Texas, 78218
San Diego Sports Medicine & Family Health Center
San Diego, California, 92120
Sunset Medical Research
Sunset, Louisiana, 70584
Liberty Research Center
Tacoma, Washington, 98405
Southwest Florida Clinical Research Center
Tampa, Florida, 33609
Quality Care Medical Center, Inc.
Vista, California, 92084
Partners in Primary Care
Voorhees Township, New Jersey, 08043
Family Practice Center of Wadsworth, Inc.
Wadsworth, Ohio, 44281
Omega Medical Research
Warwick, Rhode Island, 02886
Palm Beach Research Center
West Palm Beach, Florida, 33409
Clinical Pharmacology Study Group
Worcester, Massachusetts, 01610
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 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.
- Conditions
- Lower Back Pain
- Being tested
- Carisoprodol SR, 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 SRDrug
Also called sustained release(SR)
700 mg twice daily
Carisoprodol SRDrug
Also called sustained release(SR) tablet
500 mg twice daily
PlaceboDrug
Also called no other name
Placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| Carisoprodol 700mg | Experimental | tablet sustained release (SR) Receives: Drug: Carisoprodol SR |
| Carisoprodol 500mg | Experimental | sustained release(SR) tablet Receives: Drug: Carisoprodol SR |
| Placebo | Placebo comparator | tablet Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject Rating of Pain on a 100-point Visual Analog Scale (VAS)
the scale used was from 0 to 100 mm. 0 equaled no pain and 100 equaled maximum pain.participants measure their pain before treatment and during treatment at each visit
Measured: up to 14 days
Secondary outcomes (2)
Subject Functional Assessment Based on the Roland-Morris Disability Questionnaire (RMDQ)
Measured: up to 14 days
Adverse Event Assessment
the number of adverse events reported during the course of the study as reported by the participants
Measured: up to 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2008 (estimated)
- Study startApr 2008
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lower Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 840 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meda Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lewis M. Fredane, MD, Study director, Meda Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00671502
- Sponsor's protocol ID
- MP510
- Status last verified
- Oct 2011
- First submitted
- 1 May 2008
- Last updated
- 9 Nov 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00671502
- Acronym / sponsor ID
- MP510
- Conditions
- Lower Back Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 840 participants (actual)
- Lead sponsor
- Meda PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 5 May 2008 (estimated)
- Results
- Posted 9 Nov 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Carisoprodol 700mg | Experimental | Drug: Carisoprodol SRtablet sustained release (SR) |
| Carisoprodol 500mg | Experimental | Drug: Carisoprodol SRsustained release(SR) tablet |
| Placebo | Placebo comparator | Drug: Placebotablet |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carisoprodol SRAlso: sustained release(SR)700 mg twice daily | Drug | Carisoprodol 700mg |
| Carisoprodol SRAlso: sustained release(SR) tablet500 mg twice daily | Drug | Carisoprodol 500mg |
| PlaceboAlso: no other namePlacebo tablet | Drug | Placebo |
Primary outcome
Subject Rating of Pain on a 100-point Visual Analog Scale (VAS)
Time frame: up to 14 days
the scale used was from 0 to 100 mm. 0 equaled no pain and 100 equaled maximum pain.participants measure their pain before treatment and during treatment at each visit
2 secondary outcomes
Subject Functional Assessment Based on the Roland-Morris Disability Questionnaire (RMDQ)
Time frame: up to 14 days
Adverse Event Assessment
Time frame: up to 21 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Lower Back Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lewis M. Fredane, MD study director
Meda Pharmaceuticals
68 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Carisoprodol SR in people with Lower Back Pain, run by Meda Pharmaceuticals at 68 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 9 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 68 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 9 Nov 2011). 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 Rating of Pain on a 100-point Visual Analog Scale (VAS) (time frame: up to 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Nov 2011.