Opioid-induced Bowel Dysfunction: Pivotal Assessment of Lubiprostone
OPAL
A Multi-center, Randomized, Double-Blinded Study of the Efficacy and Safety of Lubiprostone in Patients With Opioid-induced Bowel Dysfunction (OBD)
1 other identifier
interventional
439
2 countries
95
Brief Summary
The primary purpose of this study is to evaluate the efficacy and safety of lubiprostone administration in patients 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 Aug 2007
95 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
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 4, 2008
CompletedFirst Posted
Study publicly available on registry
January 16, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedResults Posted
Study results publicly available
February 3, 2016
CompletedDecember 16, 2019
December 1, 2015
1.6 years
January 4, 2008
November 22, 2013
December 6, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Mean Weekly Spontaneous Bowel Movements at Week 8
Spontaneous bowel movements (SBMs) are defined as bowel movements without the aid of drugs.
at Week 8
Secondary Outcomes (5)
Mean Number of Spontaneous Bowel Movements (SBM) Per Week Within 12 Weeks
within 12 weeks
Number of Participants With the First Post-dose Spontaneous Bowel Movement Within 48 Hours Post-dose
within 48 hours post-dose
Number of Participants Classified as Responders
within 12 weeks
Mean Change From Baseline in Straining, Stool Consistency, Constipation Severity, Abdominal Bloating, Abdominal Discomfort, and Bowel Habit Regularity
within 12 weeks
Participant Reported Outcome of Treatment Effectiveness
within 12 weeks
Study Arms (2)
Placebo
PLACEBO COMPARATOR0 mcg capsules twice daily (BID)
Lubiprostone
EXPERIMENTAL24 mcg capsules twice daily (BID)
Interventions
Eligibility Criteria
You may qualify if:
- Consistent treatment for chronic, non-cancer-related pain with any full agonist opioid for at least 30 days prior to screening.
- Diagnosis of opioid-induced bowel dysfunction (OBD) as confirmed during the screening period.
- If patient has a history of chronic constipation, condition must have been exacerbated by initiation of opioid treatment.
- Use of prescribed or Over-the-Counter (OTC) medication that affects gastrointestinal motility (other than opioid therapy) must be discontinued during the study.
- If treated for clinical depression with Selective serotonin reuptake inhibitor (SSRIs), Serotonin-norepinephrine reuptake inhibitor (SNRIs), or Monoamine oxidase inhibitor (MAO) inhibitors, treatment must have been at a stable dose for at least 30 days prior to screening.
- Use of laxative and stool softeners (with the exception of approved rescue medications) must be discontinued while on study.
You may not qualify if:
- Treatment with opioid therapy for cancer-related pain, abdominal pain, scleroderma, and/or for the management of drug addiction.
- Patient has been treated for cancer in the past 5 years (with the exception of localized basal cell, squamous cell skin cancer, or in situ cancer that has been resected).
- Opioid dose adjustment (+/- 30%), and/or change in opioid agent or route of administration within 30 days of screening.
- Gastrointestinal or abdominal surgical procedures within 90 days prior to screening.
- Non-ambulatory patients, or those who are unable to eat/drink, take oral medications, or to hold down oral medications due to vomiting.
- Female patients of childbearing potential who are unable/unwilling to use protocol-specified method(s) of birth control and/or are pregnant, nursing, or plan to become pregnant or nurse during the study.
- Prior use of Amitiza, lubiprostone, SPI-0211, or RU-0211.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sucampo Pharma Americas, LLClead
- Sucampo Pharmaceuticals, Inc.collaborator
Study Sites (95)
The Birmingham Pain Center
Birmingham, Alabama, 35242, United States
Simon Williamson Clinic, PC
Hueytown, Alabama, 35023, United States
Alabama Orthopedic Clinic
Mobile, Alabama, 36608, United States
Clinical Research Advantage, Inc./ Mesa Family Medical Center
Mesa, Arizona, 85203, United States
Clinical Research Advantage, Inc.
Tempe, Arizona, 85282, United States
Harmony Clinical Research, Inc.
Tucson, Arizona, 85705, United States
Verona Clinical Research, Inc.
Tucson, Arizona, 85710-3539, United States
Quality of Life Medical & Research Center, LLC
Tucson, Arizona, 85712, United States
Genova Clinical Research, Inc.
Tucson, Arizona, 85741, United States
Pusch Ridge Family Medicine / WC Clinical Research
Tucson, Arizona, 85741, United States
Advanced Clinical Research Institute
Anaheim, California, 92801, United States
Orange County Clinical Trials, Inc.
Anaheim, California, 92801, United States
Gregory J. Wiener, MD PC
Chula Vista, California, 91910, United States
Digestive and Liver Disease Specialists
Garden Grove, California, 92840, United States
RX Clinical Research, Inc
Garden Grove, California, 92843, United States
Physicians Clinical Research Corporation
Laguna Hills, California, 92653, United States
Loma Linda University Physicians Medical Group
Loma Linda, California, 92354, United States
HealthCare Partners Medical Group
Long Beach, California, 90807, United States
Impact Clinical Trials
Los Angeles, California, 90036, United States
The Regents of the University of California, Los Angeles
Los Angeles, California, 90095, United States
Pasadena Rehabilitation Institute
Pasadena, California, 91105, United States
Northern California Research Corporation
Sacramento, California, 95831, United States
SB Family Medicine
Solana Beach, California, 92075, United States
Lynn Institute of the Rockies
Colorado Springs, Colorado, 80909, United States
Lynn Institute of Pueblo
Pueblo, Colorado, 81001, United States
Advanced Diagnostic Pain Treatment Center
New Haven, Connecticut, 06511, United States
International Research Clinicians of Conneticut
Ridgefield, Connecticut, 06877, United States
New England Research Associates, LLC
Trumbull, Connecticut, 06611, United States
Meridien Research
Brooksville, Florida, 34613, United States
South Lake Pain Institute
Clermont, Florida, 34711, United States
Century Clinical Research
Daytona Beach, Florida, 32117, United States
International Medical Research
Daytona Beach, Florida, 32117, United States
Clinical Physiology Associates/Clinical Study Center
Fort Myers, Florida, 33916, United States
Southeaster Integrated Medical, PL d/b/a Florida Medical Research Institute
Gainesville, Florida, 32607, United States
Palm Beach Research Center
West Palm Beach, Florida, 33409, United States
North Georgia Premier Research
Dawsonville, Georgia, 30534, United States
Best Clinical Research
Decatur, Georgia, 30034, United States
Drug Studies America
Marietta, Georgia, 30060, United States
Pinnacle Trials Inc.
Stockbridge, Georgia, 30281, United States
Rosemark Women Care Specialists
Idaho Falls, Idaho, 83404, United States
Saltzer Medical Group
Nampa, Idaho, 83686, United States
Millenium Pain Center
Bloomington, Illinois, 61701, United States
University of Illinois Medical Center
Chicago, Illinois, 60612, United States
Redhead Research Inc., dba Research Associates of Central Illinois
Peoria, Illinois, 61614, United States
Integrated Clinical Trial Services, Inc.
West Des Moines, Iowa, 50265, United States
The Pain Treatment Center of the Bluegrass and Ballard Wright, MD PSC
Lexington, Kentucky, 40503, United States
Gulf Coast Research, LLC
Baton Rouge, Louisiana, 70808, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112, United States
The Willis-Knighton Pain Management Center
Shreveport, Louisiana, 71103, United States
Pain and Rehabilitation Medicine
Bethesda, Maryland, 20814, United States
The Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Professional Clinical Research, Benzonia
Benzonia, Michigan, 49616, United States
Center for Clinical Studies
Dearborn, Michigan, 48124, United States
Apex Medical Research, AMR, Inc.
Flint, Michigan, 48504, United States
Digestive Health Specialists, PA
Tupelo, Mississippi, 38801, United States
Impact Clinical Trials, Las Vegas
Las Vegas, Nevada, 89106, United States
Office of Stephen H. Miller, MD
Las Vegas, Nevada, 89106, United States
University of Nevada
Reno, Nevada, 89557, United States
Cooper Health System
Camden, New Jersey, 08103, United States
UMDNJ
Stratford, New Jersey, 08084, United States
Partners in Primary Care
Voorhees Township, New Jersey, 08043, United States
Abraham D. Morganoff, MD PA
Watchung, New Jersey, 07069, United States
Northway Medical Associates
Fulton, New York, 13069, United States
Long Island Clinical Research Associates, LLP
Great Neck, New York, 11021, United States
Long Island Gastrointestinal Research Group
Great Neck, New York, 11023, United States
University of Rochester
Rochester, New York, 14642, United States
Diversified Research
Durham, North Carolina, 27704, United States
Medoff Medical/ Vital re:Search
Greensboro, North Carolina, 27408, United States
Carolina Pharmaceutical Research
Statesville, North Carolina, 28625, United States
Center for Clinical Research, LLC
Winston-Salem, North Carolina, 27103, United States
St. Alexius Medical Center
Bismarck, North Dakota, 58501, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
COR Clinical Research, LLC
Oklahoma City, Oklahoma, 73103, United States
Pain Research of Oregon, LLC
Eugene, Oregon, 97401, United States
Affinity Research
Portland, Oregon, 97219, United States
Private Practice of Dr. Hasan
Allentown, Pennsylvania, 18104, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Preferred Primary Care Physicians
Uniontown, Pennsylvania, 15401, United States
Partners in Clinical Research
Cumberland, Rhode Island, 02864, United States
University Gastroenterology
Providence, Rhode Island, 02905, United States
Trident Institute of Medical Research, LLC
North Charleston, South Carolina, 29406, United States
Southeastern Clinical Research
Chattanooga, Tennessee, 37403, United States
Comprehensive Pain Specialists, PLLC
Hendersonville, Tennessee, 37075, United States
Vanderbilt University - Interventional Pain Center
Nashville, Tennessee, 37232, United States
Integrity Clinical Research, LLC
Savannah, Tennessee, 38372, United States
Dallas VA Research Corporation, Inc.
Dallas, Texas, 75216, United States
Bexar Clinical Trials, LLC
Dallas, Texas, 75234, United States
Permian Research Foundation
Odessa, Texas, 79761, United States
Bexar Clinical Trials, LLC
Richardson, Texas, 75082, United States
Salt Lake Research, PLLC
Salt Lake City, Utah, 84107, United States
Digestive and Liver Disease Specialists
Norfolk, Virginia, 23502, United States
General Clinical Research Center, Virginia Commonwealth University, North Hospital
Richmond, Virginia, 23298, United States
Metro Physicians a Division of Wheaton Franciscan Medical Group
Milwaukee, Wisconsin, 53221, United States
Clement J. Zablocki VA Medical Center
Milwaukee, Wisconsin, 53295, United States
Health Sciences Center
Hamilton, Ontario, L8N 3Z5, Canada
Related Publications (1)
Cryer B, Katz S, Vallejo R, Popescu A, Ueno R. A randomized study of lubiprostone for opioid-induced constipation in patients with chronic noncancer pain. Pain Med. 2014 Nov;15(11):1825-34. doi: 10.1111/pme.12437. Epub 2014 Apr 9.
PMID: 24716835DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Three participants were randomized to the wrong product, so only the safety evaluable set includes all participants according to the product actually received.
Results Point of Contact
- Title
- Medical Information Call Center
- Organization
- Mallinckrodt
Study Officials
- STUDY DIRECTOR
Clinical Team Leader
Mallinckrodt
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 4, 2008
First Posted
January 16, 2008
Study Start
August 1, 2007
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
December 16, 2019
Results First Posted
February 3, 2016
Record last verified: 2015-12
Data Sharing
- IPD Sharing
- Will not share