Opioid-induced Bowel Dysfunction (OBD) Pivotal Assessment of Lubiprostone (OPAL)
A Multicenter, Randomized, Placebo-controlled, Double-blinded Study of the Efficacy and Safety of Lubiprostone in Subjects With Opioid-induced Bowel Dysfunction
1 other identifier
interventional
439
7 countries
142
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2010
Shorter than P25 for phase_3
142 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 20, 2011
CompletedFirst Posted
Study publicly available on registry
February 17, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedResults Posted
Study results publicly available
December 24, 2019
CompletedFebruary 11, 2020
February 1, 2013
11 months
January 20, 2011
December 2, 2019
February 3, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants Classified as Treatment Responders Within 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.
12 weeks
Secondary Outcomes (4)
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
Number of SBMs Per Week at Week 12
at Week 12
Number of SBMs Per Week Overall
within 14 weeks
Study Arms (2)
Lubiprostone
EXPERIMENTAL24 mcg capsules twice daily (BID)
Placebo
PLACEBO COMPARATOR0 mcg capsules twice daily (BID)
Interventions
Matching placebo, 0 mcg administered orally twice daily (BID)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sucampo Pharma Americas, LLClead
- Sucampo Pharmaceuticals, Inc.collaborator
Study Sites (142)
North Alabama Research Center
Athens, Alabama, 35811, United States
Innovative Clinical Trials, Inc.
Birmingham, Alabama, 35205, United States
Achieve Clinical Research
Birmingham, Alabama, 35216, United States
Alabama Clinical Therapeutics
Birmingham, Alabama, 35235, United States
G&L Research, LLC
Foley, Alabama, 36535, United States
Healthscan Research
Montgomery, Alabama, 36109, United States
River Region Research
Tallassee, Alabama, 36078, United States
Anasazi Internal Medicine PC
Phoenix, Arizona, 85032, United States
Aureas Research, Inc
Little Rock, Arkansas, 72212, United States
Certified Clinical Research
Carmichael, California, 95608, United States
California Clinical Research, Inc.
Davis, California, 95616, United States
Family Medical Center
Foothill Ranch, California, 92610, United States
South Orange County Surgical Medical Group
Laguna Hills, California, 92653, United States
Clinical Trials Research
Lincoln, California, 95648, United States
Clear Vision Research
Long Beach, California, 90805, United States
Long Beach VA Medical Center
Long Beach, California, 90822, United States
Clear Vision Research
Los Angeles, California, 90023, United States
Facey Medical Foundation
Mission Hills, California, 91345, United States
North County Clinical Research
Oceanside, California, 92056, United States
SDS Clinical Trials, Inc.
Orange, California, 92868, United States
Probe Clinical Research Corporation
Riverside, California, 92501, United States
Probe Clinical Research Corporation - Santa Ana
Santa Ana, California, 92701, United States
Westlake Medical Research
Westlake Village, California, 91361, United States
Mountain View Clinical Research
Denver, Colorado, 80209, United States
Meridien Research
Bradenton, Florida, 34208, United States
Coastal Orthopedics & Pain Management
Bradenton, Florida, 34209, United States
Florida Research & Testing, LLC
Clearwater, Florida, 33755, United States
Avail Clinical Research
DeLand, Florida, 32720, United States
S&W Clinical Research
Fort Lauderdale, Florida, 33306, United States
Palm Springs Research Institute
Hialeah, Florida, 33012, United States
Kendall South Medical Center, Inc.
Miami, Florida, 33175, United States
Gastroenterology Group of Naples
Naples, Florida, 34102, United States
Physicians Regional Medical Group
Naples, Florida, 34119, United States
Ocala Rheumatology Research Center
Ocala, Florida, 34474, United States
Paddock Park Clinical Research
Ocala, Florida, 34474, United States
Journey Research, Inc.
Oldsmar, Florida, 34677, United States
Compass Research
Orlando, Florida, 32806, United States
Andres Patron, DO, PA
Pembroke Pines, Florida, 30026, United States
Advent Clinical Research Centers
Pinellas Park, Florida, 33781, United States
Gold Coast Research, LLC
Plantation, Florida, 33317, United States
Orthopedic Research Institite
Royal Palm Beach, Florida, 33411, United States
IC Research
Sanford, Florida, 32771, United States
Sarasota Memorial Pain Care Center
Sarasota, Florida, 34238, United States
Tampa Clinical Research
Tampa, Florida, 33624, United States
Southeastern Regional Research Group
Columbus, Georgia, 31904, United States
Better Health Clinical Research
Newnan, Georgia, 30265, United States
Clinical Research Atlanta
Stockbridge, Georgia, 30281, United States
Advanced Clinical Research
Boise, Idaho, 83642, United States
Sonora Clinical Research
Boise, Idaho, 83702, United States
Nautical Clinical Research
Meridian, Idaho, 83642, United States
Anesthesia/Pain Control Indiana University School of Medicine
Chicago, Illinois, 60657, United States
Knight Center for Integrated Health
Peoria, Illinois, 61614, United States
Ridge Family Practice
Council Bluffs, Iowa, 51503, United States
Lee Research Institute
Lenexa, Kansas, 66215, United States
Kentucky Medical Research Center
Lexington, Kentucky, 40504, United States
Bluegrass Internal Medicine
Owensboro, Kentucky, 42303, United States
Horizon Research Group
Baton Rouge, Louisiana, 70809, United States
Miray Medical Center
Brockton, Massachusetts, 02301, United States
The Research Institute
Springfield, Massachusetts, 01107, United States
Coastal Research
Weymouth, Massachusetts, 02190, United States
Ashok Jain, MD
Dearborn, Michigan, 48124, United States
Shores Medical Associates
Saint Clair Shores, Michigan, 48081, United States
Mid-America Clinical Research LLC
St Louis, Missouri, 63139, United States
Montana Medical Research, Inc.
Missoula, Montana, 59808, United States
Independent Clinical Researchers
Las Vegas, Nevada, 89106, United States
AB Clinical Trials
Las Vegas, Nevada, 89119, United States
Clinical Research of South Nevada
Las Vegas, Nevada, 89121, United States
Clinical Research Advantage, Inc.
Las Vegas, Nevada, 89128, United States
Lab2Marche
Las Vegas, Nevada, 89149, United States
Aloha Medical Center
Las Vegas, Nevada, 89183, United States
Edison Medical Group
Edison, New Jersey, 08817, United States
Clinical Research Program
Marlton, New Jersey, 08053, United States
Albuquerque Clinical Trials
Albuquerque, New Mexico, 87102, United States
Drug Trials America
Hartsdale, New York, 10530, United States
Family Health Medical Services PLLC
Jamestown, New York, 14701, United States
U of Rochester
Rochester, New York, 14618, United States
Medical Frontiers
Carlisle, Ohio, 45005, United States
Hightop Medical Research Center
Cincinnati, Ohio, 45224, United States
Community Research
Cincinnati, Ohio, 45227, United States
Community Research
Cincinnati, Ohio, 45245, United States
Rapid Medical Research, Inc.
Cleveland, Ohio, 44122, United States
Parsons Avenue Medical Center
Columbus, Ohio, 43207, United States
Hometown Urgent Care
Groveport, Ohio, 43125, United States
Northstar Medical Research, LLC
Middleburg Heights, Ohio, 44130, United States
Pharmacotherpy Research Associates Inc
Zanesville, Ohio, 43701, United States
COR Clinical Research, LLC
Oklahoma City, Oklahoma, 73103, United States
Sooner Clinical Research
Oklahoma City, Oklahoma, 73112, United States
Sunstone Medical Research
Medford, Oregon, 97504, United States
Fanno Creek Clinic
Portland, Oregon, 97219, United States
McMillen & Magargle
Mechanicsburg, Pennsylvania, 17055, United States
Omega Medical Research
Warwick, Rhode Island, 02886, United States
Hartwell Research Group
Anderson, South Carolina, 29621, United States
Degarmo Institute of Medical Research
Greer, South Carolina, 29651, United States
Pain Specialists of Charleston
North Charleston, South Carolina, 29406, United States
Health Concepts
Rapid City, South Dakota, 57702, United States
InvestiClin Research
Brentwood, Tennessee, 37027, United States
SCRI Research Center
Germantown, Tennessee, 38138, United States
Prevention & Strengthening Solutions, Inc.
Humboldt, Tennessee, 38343, United States
FutureSearch Trials of Neurology & Sleep Lab
Austin, Texas, 78756, United States
Jaron Winston, MD
Austin, Texas, 78757, United States
KRK Medical Research
Dallas, Texas, 75230, United States
FutureSearch Trials of Dallas, LP
Dallas, Texas, 75231, United States
Pillar Clinical Research, LLC
Dallas, Texas, 75243, United States
Galenos Research
Dallas, Texas, 75251, United States
Diversified Medical Practice, P.A.
Houston, Texas, 77027, United States
Clinical Trial Network
Houston, Texas, 77074, United States
Dependable Clinical Research
Houston, Texas, 77074, United States
Pioneer Research Solutions, Inc.
Houston, Texas, 77098, United States
Bobby Huynh
Richardson, Texas, 75080, United States
Sun Research Institute
San Antonio, Texas, 78215, United States
Spring Clinical Research
Sugar Land, Texas, 77478, United States
Pioneer Research Solutions
Sugar Land, Texas, 77479, United States
Lifetree Clinical Research
Salt Lake City, Utah, 84106, United States
ACR Research Salt Lake City
West Jordan, Utah, 84088, United States
Virginia Research Center, LLC
Midlothian, Virginia, 23114, United States
Pain Clinic-Heilig Hart Ziekenhuis Roeselare
Roeselare, Westlaan 123, 8800, Belgium
Huisartsenpraktijk De Regenboog
Antwerp, 2100, Belgium
Dr Capiau - GP Practice
Wetteren, 9230, Belgium
St. Anne's University Hospital - centrum pro
Brno, 656 91, Czechia
Nemocnice Jablonec nad Nisou, p.o.
Jablonec nad Nisou, 466 60, Czechia
Ambulance bolesti, Krajska nemocnice Liberec
Liberec, 460 63, Czechia
Klaudianova nemocnice Mlada Boleslav
Mladá Boleslav, 293 50, Czechia
Clintrial s.r.o.
Prague, 108 00, Czechia
Neurologicka ambulance
Prague, 160 00, Czechia
Regional Hospital T. B., a.s.
Zlín, 762 75, Czechia
Schmerzzentrum Berlin
Berlin, 10435, Germany
Schmerztherapeutische- Ärztezentrum Nordstadt
Hanover, 30167, Germany
Schmerz und Palliativzentrum
Wiesbaden, 65189, Germany
NZOZ Dom Sue Ryder prowadzony przez Pallmed Sp. z o.o.
Bydgoszcz, 85-796, Poland
Hagakliniken
Gothenburg, 13 28, Sweden
Karolinska University Hospita- Dept of Anaesthesia, Pain Div.
Stockholm, 4186, Sweden
S3 Clinical Research Centers
Vällingby, Stockholm 162 68, Sweden
ElyBridge Surgery
Ely, Cardiff, CF5 4AE, United Kingdom
Randalstown Medical Practice
Randalstown, Co Antrim, BT41 3AE, United Kingdom
Sea Road Surgery
Bexhill-on-Sea, E.Sussex, TN40 1JJ, United Kingdom
Sheepcot Medical Centre,
Watford, Herts, WD25 0EA, United Kingdom
Fylde Coast Clinical Research Ltd
Blackpool, Lancsashire, FY3 7EN, United Kingdom
Ballygomartin Group Practice
Belfast, Northern Ireland, BT13 3BW, United Kingdom
The Waterfront Medical Centre
Barry, Wales, CF63 4AR, United Kingdom
Valleyfield Health Center
Dunfermline, KY12 8SJ, United Kingdom
Frome Medical Practice
Frome, BA11 1EZ, United Kingdom
Mortimer Surgery
Reading, RG7 3SG, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Information Call Center
- Organization
- Mallinckrodt Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Clinical Study Leader
Mallinckrodt
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Care provider and outcomes assessor were also blinded for this double-blind trial.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 20, 2011
First Posted
February 17, 2011
Study Start
December 1, 2010
Primary Completion
November 1, 2011
Study Completion
November 1, 2011
Last Updated
February 11, 2020
Results First Posted
December 24, 2019
Record last verified: 2013-02
Data Sharing
- IPD Sharing
- Will not share