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
437
2 countries
114
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 (OBD).
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
114 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 9, 2008
CompletedFirst Posted
Study publicly available on registry
January 18, 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
December 7, 2015
CompletedDecember 10, 2019
November 1, 2015
1.6 years
January 9, 2008
November 22, 2013
December 6, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Mean Weekly Spontaneous Bowel Movement (SBM) Frequency in Subjects Without Dose Reduction Prior to Week 8
Baseline and Week 8
Secondary Outcomes (5)
Change From Baseline in Mean Weekly SBM Frequency
Baseline, Week 12, and Weeks 1-12
First Post-dose SBM
24 and 48 hours post-dose
Responder Rate
Up to 12 weeks
Mean Changes From Baseline in Straining, Stool Consistency, Constipation Severity, Abdominal Bloating, Abdominal Discomfort, and Bowel Habit Regularity
Weeks 1-12
Treatment Effectiveness
Weeks 1-12
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 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 inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), or monoamine oxidase (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:
- Opioid dose adjustment (+/- 30%), and/or change in opioid agent or route of administration within 30 days of screening.
- Non-ambulatory patients, or those who are unable to eat/drink, take oral medications, or to hold down oral medications due to vomiting.
- 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).
- Gastrointestinal or abdominal surgical procedures within 90 days prior to screening.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sucampo Pharma Americas, LLClead
- Sucampo Pharmaceuticals, Inc.collaborator
Study Sites (114)
Tuscaloosa VA Medical Center
Tuscaloosa, Alabama, 35404, United States
Carl T Hayden VA Medical Center
Phoenix, Arizona, 85012, United States
Redpoint Research
Phoenix, Arizona, 85029, United States
HOPE Research Institute, LLC
Phoenix, Arizona, 85050, United States
Clinical Research Advantage, Inc. / East Valley Family Physicians, PLC
Tempe, Arizona, 85222, United States
Premiere Pharamaceutical Research, LLC
Tempe, Arizona, 85282, United States
Harmony Clinical Research, Inc.
Tucson, Arizona, 85705, United States
Martin Bowen Hefley Knee
Little Rock, Arkansas, 72205, United States
Advanced Pain Institute
Arcadia, California, 91007, United States
Pain Institute of CA
Bakersfield, California, 93311, United States
Catalina Research Institute, LLC
Chino, California, 91710, United States
California Pain Center
Huntington Beach, California, 92647, United States
Shreenath Clinical Service
Laguna Hills, California, 92637, United States
Loma Linda University Physicians Medical Group
Loma Linda, California, 92354, United States
VA Long Beach Healthcare System
Long Beach, California, 90822-5201, United States
Rider Research Group
San Francisco, California, 94117, United States
Clinicos, LLC
Colorado Springs, Colorado, 80904, United States
Rocky Mountain Gastroenterology Associates
Lakewood, Colorado, 80215, United States
Arapahoe Gastroenterology, PC
Littleton, Colorado, 80120, United States
Metro Clinical Research, LLC
Littleton, Colorado, 80122, United States
Clinical Trial Management of Boca Raton, Inc.
Boca Raton, Florida, 33486, United States
Florida Institute of Medical Research
Jacksonville, Florida, 32257, United States
Drug Study Institute
Jupiter, Florida, 33458, United States
Gastroenterology Group of Naples
Naples, Florida, 34102, United States
Kenneth W. Ponder, MD PA
Niceville, Florida, 32578, United States
North Miami Research, Inc.
North Miami, Florida, 33161, United States
Renstar Inc.
Ocala, Florida, 34471, United States
Peninsula Research, Inc
Ormond Beach, Florida, 32174, United States
DMI Research, Inc.
Pinellas Park, Florida, 33782, United States
Sunrise Medical Research, Inc.
Plantation, Florida, 33324, United States
Accord Clinical Research, LLC
Port Orange, Florida, 32129, United States
Lovelace Scientific Resources, Inc.
Sarasota, Florida, 34233, United States
Meridien Research
St. Petersburg, Florida, 33709, United States
Clinical Research of West Florida, Inc.
Tampa, Florida, 33603, United States
Stedman Clinical Trials
Tampa, Florida, 33613, United States
Advanced Pain Management
Augusta, Georgia, 30901, United States
Global Research Partners & Consultants, Incs.
Calhoun, Georgia, 30701, United States
Q Clinical Research
Decatur, Georgia, 30035, United States
Apex Medical Research, AMR, Inc.
Chicago, Illinois, 60616, United States
Claude Mandel Medical Center
Chicago, Illinois, 60617, United States
Advanced Pain Care Clinic
Evansville, Indiana, 47630, United States
MediSphere Medical Research Center
Evansville, Indiana, 47714, United States
Davis Clinic, PC
Indianapolis, Indiana, 46260, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Gulf Coast Research, LLC
Lafayette, Louisiana, 70503, United States
Delta Research Partners, LLC
Monroe, Louisiana, 71201, United States
Louisiana Research Center, LLC
Shreveport, Louisiana, 71103, United States
Rehabilitation Team West, PA
Baltimore, Maryland, 21228, United States
Columbia Medical Practice/ RxTrials, Inc.
Columbia, Maryland, 21045, United States
Washington County Hospital Association - The Center for Clinical Research
Hagerstown, Maryland, 21742, United States
Beth Israel Deaconess Medical Center, Harvard Medical School
Boston, Massachusetts, 02215, United States
MedVadis Research Corporation
Wellesley Hills, Massachusetts, 02481, United States
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, 48047, United States
Professional Clinical Research, Inc.
Interlochen, Michigan, 49643, United States
PCM Medical Services
Lansing, Michigan, 48917, United States
Women's Health Care Specialists, PC
Paw Paw, Michigan, 49079, United States
Medical Research Associates
Traverse City, Michigan, 49684, United States
Center for Digestive Health
Troy, Michigan, 48098, United States
MAPS Applied Research Center
Edina, Minnesota, 55435, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Precise Research, Inc.
Flowood, Mississippi, 39232, United States
Medex Healthcare Research
St Louis, Missouri, 63117, United States
Montana Neuroscience Institute Foundation / Montana Spine and Pain Center
Missoula, Montana, 59802, United States
Creighton University Medical Center
Omaha, Nebraska, 68131, United States
Advanced Biomedical Research of America
Las Vegas, Nevada, 89123, United States
Lovelace Scientific Resources, Inc.
Las Vegas, Nevada, 89146, United States
Gastroenterology Research Associates
Cedar Knolls, New Jersey, 07927, United States
Central Jersey Medical Research Center
Elizabeth, New Jersey, 07202, United States
Holy Name Hospital, Institute for Clinical Research
Teaneck, New Jersey, 07666, United States
Advanced Pain Consultants
Voorhees Township, New Jersey, 08043, United States
Medex Healthcare Research, Inc.
New York, New York, 10004, United States
New York University Pain Management Center
New York, New York, 10016, United States
Research Across America
New York, New York, 10022, United States
North American Partners
Valley Stream, New York, 11580, United States
Upstate Clinical Research Associates
Williamsville, New York, 14221, United States
Randolph Medical Associates
Asheboro, North Carolina, 27203, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Carolina Research
Greenville, North Carolina, 27834, United States
Carolina Digestive Health Associates
Harrisburg, North Carolina, 28075, United States
Peters Medical Research, LLC
High Point, North Carolina, 27262, United States
Triangle Medical Research
Lexington, North Carolina, 27295, United States
Southern Gastroenterology Associates
New Bern, North Carolina, 28562, United States
Valley Medical Primary Care
Centerville, Ohio, 45459, United States
Glenway Family Medicine
Cincinnati, Ohio, 45238, United States
The Ohio State University Medical Center
Columbus, Ohio, 43210-1228, United States
Urgent Care Specialists
Dayton, Ohio, 45432, United States
RAS Health Ltd.
Marion, Ohio, 43302, United States
University of Toledo - Health Science Campus
Toledo, Ohio, 43614, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
Paradigm Research Professionals, LLP
Oklahoma City, Oklahoma, 73112, United States
Memorial Clinical Research
Oklahoma City, Oklahoma, 73134, United States
Medford Medical Clinic, LLP
Medford, Oregon, 97504, United States
Lehigh Valley Hospital - Neurosciences and Pain Research
Allentown, Pennsylvania, 18103, United States
Einstein Pain Institute
Philadelphia, Pennsylvania, 19414, United States
Jeffry A. Lindenbaum DO, PC
Yardley, Pennsylvania, 19067, United States
Baptist Medical Tower Suite 740
Knoxville, Tennessee, 37920, United States
Integrity Clinical Research, LLC
Milan, Tennessee, 38358, United States
Texas Familicare Clinical Research
Hurst, Texas, 76054, United States
DCOL Center for Clinical Research
Longview, Texas, 75605, United States
Bexar Clinical Trials, LLC
Richardson, Texas, 75082, United States
Advance Research Institute
Ogden, Utah, 84405, United States
Highland Clinical Research
Salt Lake City, Utah, 84124, United States
University of Utah
Salt Lake City, Utah, 84132-2410, United States
New River Valley Research Institute
Christiansburg, Virginia, 24073, United States
Hampton Roads Institute for Performance and Sports Medicine (HIPS)
Portsmouth, Virginia, 23707, United States
McGuire Research Institute
Richmond, Virginia, 23249, United States
Northwest Gastroenterology Associates
Bellevue, Washington, 98004, United States
Daniel R. Coulston
Spokane, Washington, 99204, United States
Hermitage Medicentre
Edmonton, Alberta, T5A 4L8, Canada
Health Sciences Centre
Winnipeg, Manitoba, R3A 1R9, Canada
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6, Canada
Pharmaceutical Integrated Research Company
London, Ontario, N5X4E7, Canada
DHC Research
Richmond Hill, Ontario, L4B 3P8, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Post-study, it was determined that lubiprostone efficacy was dose-dependently decreased with concomitant methadone use (30% higher morphine equivalent daily dose (MEDD) than parallel pivotal study NCT00595946).
Results Point of Contact
- Title
- VP, Clinical Development
- Organization
- Sucampo Pharma Americas, LLC
Study Officials
- PRINCIPAL INVESTIGATOR
Egilius L.H. Spierings, M.D., Ph.D.
MedVadis Research Corporation
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 9, 2008
First Posted
January 18, 2008
Study Start
August 1, 2007
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
December 10, 2019
Results First Posted
December 7, 2015
Record last verified: 2015-11