Opioid-induced Bowel Dysfunction (OBD) Pivotal Assessment of Lubiprostone (OPAL)
NCT ID: NCT01298219
Last Updated: 2020-02-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
439 participants
INTERVENTIONAL
2010-12-31
2011-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Lubiprostone
24 mcg capsules twice daily (BID)
Lubiprostone
24 mcg administered orally twice daily (BID)
Placebo
0 mcg capsules twice daily (BID)
Placebo
Matching placebo, 0 mcg administered orally twice daily (BID)
Interventions
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Lubiprostone
24 mcg administered orally twice daily (BID)
Placebo
Matching placebo, 0 mcg administered orally twice daily (BID)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Sucampo Pharmaceuticals, Inc.
INDUSTRY
Sucampo Pharma Americas, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Study Leader
Role: STUDY_DIRECTOR
Mallinckrodt
Locations
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North Alabama Research Center
Athens, Alabama, United States
Innovative Clinical Trials, Inc.
Birmingham, Alabama, United States
Achieve Clinical Research
Birmingham, Alabama, United States
Alabama Clinical Therapeutics
Birmingham, Alabama, United States
G&L Research, LLC
Foley, Alabama, United States
Healthscan Research
Montgomery, Alabama, United States
River Region Research
Tallassee, Alabama, United States
Anasazi Internal Medicine PC
Phoenix, Arizona, United States
Aureas Research, Inc
Little Rock, Arkansas, United States
Certified Clinical Research
Carmichael, California, United States
California Clinical Research, Inc.
Davis, California, United States
Family Medical Center
Foothill Ranch, California, United States
South Orange County Surgical Medical Group
Laguna Hills, California, United States
Clinical Trials Research
Lincoln, California, United States
Clear Vision Research
Long Beach, California, United States
Long Beach VA Medical Center
Long Beach, California, United States
Clear Vision Research
Los Angeles, California, United States
Facey Medical Foundation
Mission Hills, California, United States
North County Clinical Research
Oceanside, California, United States
SDS Clinical Trials, Inc.
Orange, California, United States
Probe Clinical Research Corporation
Riverside, California, United States
Probe Clinical Research Corporation - Santa Ana
Santa Ana, California, United States
Westlake Medical Research
Westlake Village, California, United States
Mountain View Clinical Research
Denver, Colorado, United States
Meridien Research
Bradenton, Florida, United States
Coastal Orthopedics & Pain Management
Bradenton, Florida, United States
Florida Research & Testing, LLC
Clearwater, Florida, United States
Avail Clinical Research
DeLand, Florida, United States
S&W Clinical Research
Fort Lauderdale, Florida, United States
Palm Springs Research Institute
Hialeah, Florida, United States
Kendall South Medical Center, Inc.
Miami, Florida, United States
Gastroenterology Group of Naples
Naples, Florida, United States
Physicians Regional Medical Group
Naples, Florida, United States
Ocala Rheumatology Research Center
Ocala, Florida, United States
Paddock Park Clinical Research
Ocala, Florida, United States
Journey Research, Inc.
Oldsmar, Florida, United States
Compass Research
Orlando, Florida, United States
Andres Patron, DO, PA
Pembroke Pines, Florida, United States
Advent Clinical Research Centers
Pinellas Park, Florida, United States
Gold Coast Research, LLC
Plantation, Florida, United States
Orthopedic Research Institite
Royal Palm Beach, Florida, United States
IC Research
Sanford, Florida, United States
Sarasota Memorial Pain Care Center
Sarasota, Florida, United States
Tampa Clinical Research
Tampa, Florida, United States
Southeastern Regional Research Group
Columbus, Georgia, United States
Better Health Clinical Research
Newnan, Georgia, United States
Clinical Research Atlanta
Stockbridge, Georgia, United States
Advanced Clinical Research
Boise, Idaho, United States
Sonora Clinical Research
Boise, Idaho, United States
Nautical Clinical Research
Meridian, Idaho, United States
Anesthesia/Pain Control Indiana University School of Medicine
Chicago, Illinois, United States
Knight Center for Integrated Health
Peoria, Illinois, United States
Ridge Family Practice
Council Bluffs, Iowa, United States
Lee Research Institute
Lenexa, Kansas, United States
Kentucky Medical Research Center
Lexington, Kentucky, United States
Bluegrass Internal Medicine
Owensboro, Kentucky, United States
Horizon Research Group
Baton Rouge, Louisiana, United States
Miray Medical Center
Brockton, Massachusetts, United States
The Research Institute
Springfield, Massachusetts, United States
Coastal Research
Weymouth, Massachusetts, United States
Ashok Jain, MD
Dearborn, Michigan, United States
Shores Medical Associates
Saint Clair Shores, Michigan, United States
Mid-America Clinical Research LLC
St Louis, Missouri, United States
Montana Medical Research, Inc.
Missoula, Montana, 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
Edison Medical Group
Edison, New Jersey, United States
Clinical Research Program
Marlton, New Jersey, United States
Albuquerque Clinical Trials
Albuquerque, New Mexico, United States
Drug Trials America
Hartsdale, New York, United States
Family Health Medical Services PLLC
Jamestown, New York, United States
U of Rochester
Rochester, New York, United States
Medical Frontiers
Carlisle, Ohio, United States
Hightop Medical Research Center
Cincinnati, Ohio, United States
Community Research
Cincinnati, Ohio, United States
Community Research
Cincinnati, Ohio, United States
Rapid Medical Research, Inc.
Cleveland, Ohio, United States
Parsons Avenue Medical Center
Columbus, Ohio, United States
Hometown Urgent Care
Groveport, Ohio, United States
Northstar Medical Research, LLC
Middleburg Heights, Ohio, United States
Pharmacotherpy Research Associates Inc
Zanesville, Ohio, United States
COR Clinical Research, LLC
Oklahoma City, Oklahoma, United States
Sooner Clinical Research
Oklahoma City, Oklahoma, United States
Sunstone Medical Research
Medford, Oregon, United States
Fanno Creek Clinic
Portland, Oregon, United States
McMillen & Magargle
Mechanicsburg, Pennsylvania, United States
Omega Medical Research
Warwick, Rhode Island, United States
Hartwell Research Group
Anderson, South Carolina, United States
Degarmo Institute of Medical Research
Greer, South Carolina, United States
Pain Specialists of Charleston
North Charleston, South Carolina, United States
Health Concepts
Rapid City, South Dakota, United States
InvestiClin Research
Brentwood, Tennessee, United States
SCRI Research Center
Germantown, Tennessee, United States
Prevention & Strengthening Solutions, Inc.
Humboldt, Tennessee, United States
FutureSearch Trials of Neurology & Sleep Lab
Austin, Texas, United States
Jaron Winston, MD
Austin, Texas, United States
KRK Medical Research
Dallas, Texas, United States
FutureSearch Trials of Dallas, LP
Dallas, Texas, United States
Pillar Clinical Research, LLC
Dallas, Texas, United States
Galenos Research
Dallas, Texas, United States
Diversified Medical Practice, P.A.
Houston, Texas, United States
Clinical Trial Network
Houston, Texas, United States
Dependable Clinical Research
Houston, Texas, United States
Pioneer Research Solutions, Inc.
Houston, Texas, United States
Bobby Huynh
Richardson, Texas, United States
Sun Research Institute
San Antonio, Texas, United States
Spring Clinical Research
Sugar Land, Texas, United States
Pioneer Research Solutions
Sugar Land, Texas, United States
Lifetree Clinical Research
Salt Lake City, Utah, United States
ACR Research Salt Lake City
West Jordan, Utah, United States
Virginia Research Center, LLC
Midlothian, Virginia, United States
Pain Clinic-Heilig Hart Ziekenhuis Roeselare
Roeselare, Westlaan 123, Belgium
Huisartsenpraktijk De Regenboog
Antwerp, , Belgium
Dr Capiau - GP Practice
Wetteren, , Belgium
St. Anne's University Hospital - centrum pro
Brno, , Czechia
Nemocnice Jablonec nad Nisou, p.o.
Jablonec nad Nisou, , Czechia
Ambulance bolesti, Krajska nemocnice Liberec
Liberec, , Czechia
Klaudianova nemocnice Mlada Boleslav
Mladá Boleslav, , Czechia
Clintrial s.r.o.
Prague, , Czechia
Neurologicka ambulance
Prague, , Czechia
Regional Hospital T. B., a.s.
Zlín, , Czechia
Schmerzzentrum Berlin
Berlin, , Germany
Schmerztherapeutische- Ärztezentrum Nordstadt
Hanover, , Germany
Schmerz und Palliativzentrum
Wiesbaden, , Germany
NZOZ Dom Sue Ryder prowadzony przez Pallmed Sp. z o.o.
Bydgoszcz, , Poland
Hagakliniken
Gothenburg, , Sweden
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
Fylde Coast Clinical Research Ltd
Blackpool, Lancsashire, United Kingdom
Ballygomartin Group Practice
Belfast, Northern Ireland, United Kingdom
The Waterfront Medical Centre
Barry, Wales, United Kingdom
Valleyfield Health Center
Dunfermline, , United Kingdom
Frome Medical Practice
Frome, , United Kingdom
Mortimer Surgery
Reading, , United Kingdom
Countries
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Other Identifiers
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OBD1033
Identifier Type: -
Identifier Source: org_study_id
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