Opioid-induced Bowel Dysfunction (OBD) Pivotal Assessment of Lubiprostone (OPAL)
- Conditions
- Opioid-induced Bowel Dysfunction
- Interventions
- Drug: Placebo
- Registration Number
- NCT01298219
- Lead Sponsor
- Sucampo Pharma Americas, LLC
- Brief Summary
The primary purpose of the study is to evaluate the efficacy and safety of lubiprostone administration in subjects with Opioid-induced Bowel Dysfunction.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 439
A patient can be considered for eligibility to participate if he/she:
- Has been consistently treated for chronic, noncancer-related pain with any oral, transdermal, intravenous, or subcutaneous opioid for at least 30 days prior to screening
- Is diagnosed with OBD
- Is capable of utilizing an electronic diary to report daily spontaneous bowel movements (SBMs)
- Is willing to continue opioid therapy and discontinue the use of laxatives, stool softeners, and other concomitant medications affecting gastrointestinal motility throughout the study
A patient cannot be considered for eligibility to participate if he/she:
- Uses opioids for the treatment of cancer-related pain, abdominal pain, mechanical bowel obstructions, bowel disorders, and constipation not arising from opioid use, but instead attributable to dietary, neurologic, congenital, or endocrine disorders, scleroderma, and/or for the management of drug addiction
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo 0 mcg capsules twice daily (BID) Lubiprostone Lubiprostone 24 mcg capsules twice daily (BID)
- Primary Outcome Measures
Name Time Method Number of Participants Classified as Treatment Responders Within 12 Weeks 12 weeks Spontaneous bowel movement (SBM) is defined as any BM that does not occur within 24 hours after use of rescue medication. To be classified as responders, participants are required to demonstrate at least moderate response (≥ 1 SBM improvement over baseline SBM frequency) for all treatment weeks for which observed data are available, and must additionally demonstrate a full response (≥ 3 SBMs per week) for at least 9 of the 12 treatment weeks.
- Secondary Outcome Measures
Name Time Method Number of SBMs Per Week at Week 12 at Week 12 Number of SBMs Per Week Overall within 14 weeks Overall is defined as the length of time from first dose to last follow-up within 2 weeks after last dose.
Number of SBMs Per Week at Week 8 at Week 8 Number of Participants Who Experienced First SBM Within 48 Hours After Dose Initiation within 48 hours post-dose
Trial Locations
- Locations (140)
Hartwell Research Group
🇺🇸Anderson, South Carolina, United States
North Alabama Research Center
🇺🇸Athens, Alabama, United States
Sunstone Medical Research
🇺🇸Medford, Oregon, United States
South Orange County Surgical Medical Group
🇺🇸Laguna Hills, California, United States
Galenos Research
🇺🇸Dallas, Texas, United States
Schmerz und Palliativzentrum
🇩🇪Wiesbaden, Germany
Anesthesia/Pain Control Indiana University School of Medicine
🇺🇸Chicago, Illinois, United States
Kendall South Medical Center, Inc.
🇺🇸Miami, Florida, United States
Diversified Medical Practice, P.A.
🇺🇸Houston, Texas, United States
Pioneer Research Solutions, Inc.
🇺🇸Houston, Texas, United States
Independent Clinical Researchers
🇺🇸Las Vegas, Nevada, United States
AB Clinical Trials
🇺🇸Las Vegas, Nevada, United States
Clinical Research of South Nevada
🇺🇸Las Vegas, Nevada, United States
Clinical Research Advantage, Inc.
🇺🇸Las Vegas, Nevada, United States
Lab2Marche
🇺🇸Las Vegas, Nevada, United States
Aloha Medical Center
🇺🇸Las Vegas, Nevada, United States
Healthscan Research
🇺🇸Montgomery, Alabama, United States
California Clinical Research, Inc.
🇺🇸Davis, California, United States
Family Medical Center
🇺🇸Foothill Ranch, California, United States
Facey Medical Foundation
🇺🇸Mission Hills, California, United States
SDS Clinical Trials, Inc.
🇺🇸Orange, California, United States
Probe Clinical Research Corporation - Santa Ana
🇺🇸Santa Ana, California, United States
KRK Medical Research
🇺🇸Dallas, Texas, United States
Westlake Medical Research
🇺🇸Westlake Village, California, United States
ACR Research Salt Lake City
🇺🇸West Jordan, Utah, United States
Schmerztherapeutische- Ärztezentrum Nordstadt
🇩🇪Hannover, Germany
NZOZ Dom Sue Ryder prowadzony przez Pallmed Sp. z o.o.
🇵🇱Bydgoszcz, Poland
Clinical Trials Research
🇺🇸Lincoln, California, United States
River Region Research
🇺🇸Tallassee, Alabama, United States
G&L Research, LLC
🇺🇸Foley, Alabama, United States
Certified Clinical Research
🇺🇸Carmichael, California, United States
Family Health Medical Services PLLC
🇺🇸Jamestown, New York, United States
Medical Frontiers
🇺🇸Carlisle, Ohio, United States
Probe Clinical Research Corporation
🇺🇸Riverside, California, United States
North County Clinical Research
🇺🇸Oceanside, California, United States
Southeastern Regional Research Group
🇺🇸Columbus, Georgia, United States
Bluegrass Internal Medicine
🇺🇸Owensboro, Kentucky, United States
Better Health Clinical Research
🇺🇸Newnan, Georgia, United States
Ridge Family Practice
🇺🇸Council Bluffs, Iowa, United States
Lee Research Institute
🇺🇸Lenexa, Kansas, United States
Mid-America Clinical Research LLC
🇺🇸Saint Louis, Missouri, United States
Shores Medical Associates
🇺🇸Saint Clair Shores, Michigan, United States
Knight Center for Integrated Health
🇺🇸Peoria, Illinois, United States
Horizon Research Group
🇺🇸Baton Rouge, Louisiana, United States
The Research Institute
🇺🇸Springfield, Massachusetts, United States
Drug Trials America
🇺🇸Hartsdale, New York, United States
Nemocnice Jablonec nad Nisou, p.o.
🇨🇿Jablonec nad Nisou, Czechia
Parsons Avenue Medical Center
🇺🇸Columbus, Ohio, United States
Community Research
🇺🇸Cincinnati, Ohio, United States
Pharmacotherpy Research Associates Inc
🇺🇸Zanesville, Ohio, United States
U of Rochester
🇺🇸Rochester, New York, United States
Omega Medical Research
🇺🇸Warwick, Rhode Island, United States
Hometown Urgent Care
🇺🇸Groveport, Ohio, United States
Rapid Medical Research, Inc.
🇺🇸Cleveland, Ohio, United States
Hightop Medical Research Center
🇺🇸Cincinnati, Ohio, United States
Northstar Medical Research, LLC
🇺🇸Middleburg Heights, Ohio, United States
McMillen & Magargle
🇺🇸Mechanicsburg, Pennsylvania, United States
Virginia Research Center, LLC
🇺🇸Midlothian, Virginia, United States
Pain Specialists of Charleston
🇺🇸North Charleston, South Carolina, United States
FutureSearch Trials of Dallas, LP
🇺🇸Dallas, Texas, United States
Neurologicka ambulance
🇨🇿Praha 6, Czechia
Spring Clinical Research
🇺🇸Sugar Land, Texas, United States
Pioneer Research Solutions
🇺🇸Sugar Land, Texas, United States
Ambulance bolesti, Krajska nemocnice Liberec
🇨🇿Liberec, Czechia
Pillar Clinical Research, LLC
🇺🇸Dallas, Texas, United States
Bobby Huynh
🇺🇸Richardson, Texas, United States
Clintrial s.r.o.
🇨🇿Praha 10, Czechia
Clinical Trial Network
🇺🇸Houston, Texas, United States
Dependable Clinical Research
🇺🇸Houston, Texas, United States
Pain Clinic-Heilig Hart Ziekenhuis Roeselare
🇧🇪Roeselare, Westlaan 123, Belgium
Dr Capiau - GP Practice
🇧🇪Wetteren, Belgium
Klaudianova nemocnice Mlada Boleslav
🇨🇿Mlada Boleslav, Czechia
St. Anne's University Hospital - centrum pro
🇨🇿Brno, Czechia
Hagakliniken
🇸🇪Gothenburg, Sweden
Fylde Coast Clinical Research Ltd
🇬🇧Blackpool, Lancsashire, United Kingdom
Innovative Clinical Trials, Inc.
🇺🇸Birmingham, Alabama, United States
COR Clinical Research, LLC
🇺🇸Oklahoma City, Oklahoma, United States
Achieve Clinical Research
🇺🇸Birmingham, Alabama, United States
Alabama Clinical Therapeutics
🇺🇸Birmingham, Alabama, United States
Anasazi Internal Medicine PC
🇺🇸Phoenix, Arizona, United States
Fanno Creek Clinic
🇺🇸Portland, Oregon, United States
Mountain View Clinical Research
🇺🇸Denver, Colorado, United States
Sooner Clinical Research
🇺🇸Oklahoma City, Oklahoma, United States
Sun Research Institute
🇺🇸San Antonio, Texas, United States
Compass Research
🇺🇸Orlando, Florida, United States
Tampa Clinical Research
🇺🇸Tampa, Florida, United States
Coastal Orthopedics & Pain Management
🇺🇸Bradenton, Florida, United States
Aureas Research, Inc
🇺🇸Little Rock, Arkansas, United States
Clear Vision Research
🇺🇸Los Angeles, California, United States
Long Beach VA Medical Center
🇺🇸Long Beach, California, United States
S&W Clinical Research
🇺🇸Fort Lauderdale, Florida, United States
Avail Clinical Research
🇺🇸DeLand, Florida, United States
Clinical Research Atlanta
🇺🇸Stockbridge, Georgia, United States
Edison Medical Group
🇺🇸Edison, New Jersey, United States
SCRI Research Center
🇺🇸Germantown, Tennessee, United States
Regional Hospital T. B., a.s.
🇨🇿Zlin, Czechia
Schmerzzentrum Berlin
🇩🇪Berlin, Germany
Karolinska University Hospita- Dept of Anaesthesia, Pain Div.
🇸🇪Stockholm, Sweden
S3 Clinical Research Centers
🇸🇪Vällingby, Sweden
ElyBridge Surgery
🇬🇧ELY, Cardiff, United Kingdom
Randalstown Medical Practice
🇬🇧Randalstown, Co Antrim, United Kingdom
Sea Road Surgery
🇬🇧Bexhill on Sea, E.Sussex, United Kingdom
Sheepcot Medical Centre,
🇬🇧Watford, Herts, United Kingdom
Mortimer Surgery
🇬🇧Reading, United Kingdom
The Waterfront Medical Centre
🇬🇧Barry, Wales, United Kingdom
Valleyfield Health Center
🇬🇧Dunfermline, United Kingdom
Frome Medical Practice
🇬🇧Frome, United Kingdom
Meridien Research
🇺🇸Bradenton, Florida, United States
Gold Coast Research, LLC
🇺🇸Plantation, Florida, United States
Sonora Clinical Research
🇺🇸Boise, Idaho, United States
Physicians Regional Medical Group
🇺🇸Naples, Florida, United States
Paddock Park Clinical Research
🇺🇸Ocala, Florida, United States
Montana Medical Research, Inc.
🇺🇸Missoula, Montana, United States
Advent Clinical Research Centers
🇺🇸Pinellas Park, Florida, United States
IC Research
🇺🇸Sanford, Florida, United States
Ashok Jain, MD
🇺🇸Dearborn, Michigan, United States
Clinical Research Program
🇺🇸Marlton, New Jersey, United States
Palm Springs Research Institute
🇺🇸Hialeah, Florida, United States
Andres Patron, DO, PA
🇺🇸Pembroke Pines, Florida, United States
Gastroenterology Group of Naples
🇺🇸Naples, Florida, United States
Florida Research & Testing, LLC
🇺🇸Clearwater, Florida, United States
Sarasota Memorial Pain Care Center
🇺🇸Sarasota, Florida, United States
Prevention & Strengthening Solutions, Inc.
🇺🇸Humboldt, Tennessee, United States
Advanced Clinical Research
🇺🇸Boise, Idaho, United States
Ocala Rheumatology Research Center
🇺🇸Ocala, Florida, United States
Journey Research, Inc.
🇺🇸Oldsmar, Florida, United States
Orthopedic Research Institite
🇺🇸Royal Palm Beach, Florida, United States
Nautical Clinical Research
🇺🇸Meridian, Idaho, United States
Miray Medical Center
🇺🇸Brockton, Massachusetts, United States
Coastal Research
🇺🇸Weymouth, Massachusetts, United States
Huisartsenpraktijk De Regenboog
🇧🇪Antwerp, Belgium
Lifetree Clinical Research
🇺🇸Salt Lake City, Utah, United States
Kentucky Medical Research Center
🇺🇸Lexington, Kentucky, United States
FutureSearch Trials of Neurology & Sleep Lab
🇺🇸Austin, Texas, United States
Jaron Winston, MD
🇺🇸Austin, Texas, United States
Albuquerque Clinical Trials
🇺🇸Albuquerque, New Mexico, United States
Degarmo Institute of Medical Research
🇺🇸Greer, South Carolina, United States
Health Concepts
🇺🇸Rapid City, South Dakota, United States
InvestiClin Research
🇺🇸Brentwood, Tennessee, United States
Ballygomartin Group Practice
🇬🇧Belfast, Northern Ireland, United Kingdom