Opioid-induced Bowel Dysfunction: Long-Term Assessment of Lubiprostone
A Multi-center, Open-labeled Study of the Long-term Safety and Efficacy of Lubiprostone in Patients With Opioid-induced Bowel Dysfunction
1 other identifier
interventional
439
2 countries
123
Brief Summary
The purpose of this study is to evaluate the long-term safety and efficacy of lubiprostone administration in participants 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 2007
123 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, 2007
CompletedFirst Submitted
Initial submission to the registry
February 11, 2008
CompletedFirst Posted
Study publicly available on registry
February 21, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedResults Posted
Study results publicly available
December 30, 2019
CompletedJanuary 21, 2020
March 1, 2018
1.8 years
February 11, 2008
July 12, 2016
January 10, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Mean Weekly Spontaneous Bowel Movements (SBMs) Per Month
A Spontaneous Bowel Movement (SBM) is defined as any bowel movement (BM) that did not occur within the 24-hour period following use of a rescue medication.
Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
Mean Weekly Bowel Movements (BMs) Per Month
A Bowel Movement (BM) is defined as any BM (whether spontaneous or not)
Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
Secondary Outcomes (10)
Number of Participants Classified as Monthly Responders
Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
Straining Associated With Spontaneous Bowel Movements by Month
Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
Stool Consistency of Spontaneous Bowel Movements by Month
Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
Constipation Severity by Month
Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
Abdominal Bloating by Month
Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
- +5 more secondary outcomes
Study Arms (1)
All Participants
EXPERIMENTALLubiprostone: 24 mcg capsule twice daily (BID) for 36 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Has completed 12 weeks of blinded treatment in NCT00595946 or NCT00597428
- Will continue to be treated consistently for chronic, non-cancer-related pain with any full agonist opiate and will continue opiate therapy for the duration of the study
- Willing to continue to abstain from use of disallowed medications as defined per protocol
You may not qualify if:
- Has newly diagnosed impaired renal function identified at the Screening Visit \[i.e., serum creatinine concentration \> 1.8 milligrams per deciliter (mg/dL)\]
- Has experienced an unexplained and/or clinically significant weight loss defined as \> 5% within 90 days prior to Screening Visit.
- Has plans to participate in another trial with an investigational drug or device during the course of the extension study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (123)
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
Redpoint Research
Phoenix, Arizona, 85029, United States
HOPE Research Institute
Phoenix, Arizona, 85050, United States
Clinical Research Advantage, Inc.
Phoenix, Arizona, 85128, United States
Clinical Research Advantage, Inc. / East Valley Family Physicians, PLC
Tempe, Arizona, 85222, United States
Clinical Research Advantage, Inc.
Tempe, Arizona, 85282, United States
Premiere Pharamaceutical Research, LLC
Tempe, Arizona, 85282, United States
Genova Clinical Research
Tucson, Arizona, 85704, United States
Verona Clinical Research, Inc.
Tucson, Arizona, 85710, United States
Advanced Clinical Therapeutics, LLC
Tucson, Arizona, 85712, United States
Paradigm Clinical Research, Inc.
Tucson, Arizona, 85712, United States
Quality of Life Medical & Research Center, LLC
Tucson, Arizona, 85712, United States
Wilson and Charani
Tucson, Arizona, 85741, United States
Arkansas Pain Research
Hot Springs, Arkansas, 71913, United States
Teton Research, LLC
Little Rock, Arkansas, 72205, United States
Advanced Clinical Research Institute
Anaheim, California, 92801, United States
Orange County Clinical Trials
Anaheim, California, 92801, United States
Advanced Pain Institute
Arcadia, California, 91007, United States
Impact Clinical Trials
Beverly Hills, California, 90036, United States
Digestive and Liver Disease Specialists
Garden Grove, California, 92840, United States
RX Clinical Research, Inc.
Garden Grove, California, 92843, United States
Loma Linda University
Loma Linda, California, 92354, United States
Pasadena Rehabilitation Institute
Pasadena, California, 91105, United States
Northern California Research Corporation
Sacramento, California, 95831, United States
Rider Research Group
San Francisco, California, 94117, United States
ShahShreenath Clinical Service
Yorba Linda, California, 92886, United States
Clinicos, LLC
Colorado Springs, Colorado, 80904, United States
Lynn Institute of the Rockies
Colorado Springs, Colorado, 80907, United States
Advanced Diagnostic Pain Treatment Center
New Haven, Connecticut, 06511, United States
Meridien Research
Brooksville, Florida, 34601, United States
Century Clinical Research Inc
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
Southeastern Integrated Medical, PL dba Florida
Gainesville, Florida, 32607, United States
Century Clinical Research
Holly Hill, Florida, 32117, United States
Florida Institute of Medical Research
Jacksonville, Florida, 32257, United States
Drug Study Institute
Jupiter, Florida, 33458, United States
Sunrise Medical Research, Inc.
Lauderdale Lakes, Florida, 33319, United States
Kenneth W. Ponder, MD, PA
Niceville, Florida, 32578, United States
North Miami Research Inc.
North Miami, Florida, 33161, United States
DMI Health Care Group, Inc.
Pinellas Park, Florida, 33782, United States
Accord Clinical Research, LLC
Port Orange, Florida, 32129, 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
Palm Beach Research Center
West Palm Beach, Florida, 33409, United States
Pinnacle Trials Inc.
Atlanta, Georgia, 30329, 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
Millenium Pain Center
Bloomington, Illinois, 61701, United States
University of Illinois at Chicago: Department of Medicine
Chicago, Illinois, 60612, United States
Apex Medical Research, AMR, Inc
Chicago, Illinois, 60616, United States
Redhead Research Inc.
Peoria, Illinois, 161614, United States
MediSphere Medical Research Center, LLC
Evansville, Indiana, 47714, United States
Davis Clinic, PC
Indianapolis, Indiana, 46260, United States
Intergrated Clinical Trial Services, Inc
West Des Moines, Iowa, 50265, United States
The Pain Treatment Center of the Bluegrass
Lexington, Kentucky, 40503, United States
Louisiana Research Center, LLC
Shreveport, Louisiana, 71103, United States
The Willis-Knighton Interventional Pain Center
Shreveport, Louisiana, 71105, United States
Pain and Rehabilitation Medicine
Bethesda, Maryland, 20814, United States
Columbia Medical Practice/ RxTrials, Inc.
Columbia, Maryland, 21045, United States
Brigham and Women's Hosptial
Chestnut Hill, Massachusetts, 02467, United States
MedVadis Research Corporation
Wellesley Hills, Massachusetts, 02481, United States
Center for Clinical Studies
Dearborn, Michigan, 48124, United States
Apex Medical Research, AMR, Inc.
Flint, Michigan, 48504, United States
Professional Clinical Research - Interlochen
Interlochen, Michigan, 49641, United States
Beyer Research
Kalamazoo, Michigan, 49009, 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
Medex Healthcare Research Inc.
St Louis, Missouri, 63117, United States
Montana Neuroscience Institute Foundation / Montana Spine and Pain Center
Missoula, Montana, 59802, United States
Office of Stephen H. Miller, MD
Las Vegas, Nevada, 89106, United States
Affiliated Clinical Research, Inc.
Las Vegas, Nevada, 89144, United States
Ladder Family Practice
Las Vegas, Nevada, 89146, United States
Impact Clinical Trials
Las Vegas, Nevada, 89206, United States
Gastroenterology Research Associates, LLC
Cedar Knolls, New Jersey, 07927, United States
Central Jersey Medical Research Center
Elizabeth, New Jersey, 07202, United States
Virtua Lumberton Family Physicians
Lumberton, New Jersey, 08048, United States
Holy Name Hospital
Teaneck, New Jersey, 07666, United States
Long Island Gastrointestinal Research Group
Great Neck, New York, 11023, United States
NYU Pain Management Center
New York, New York, 10016, United States
Research Across America
New York, New York, 10022, United States
University of Rochester, Pain Treatment Center
Rochester, New York, 14642, United States
Upstate Clinical Research Associates
Williamsville, New York, 14221, United States
Duke University Medical Center
Durham, North Carolina, 27705, United States
Carolina Research
Greenville, North Carolina, 27834, United States
Peters Medical Research, LLC
High Point, North Carolina, 27262, United States
The Center for Clinical Research
Winston-Salem, North Carolina, 27103, United States
Glenway Family Medicine
Cincinnati, Ohio, 45238, United States
The Ohio State University Medical Center
Columbus, Ohio, 43210, United States
Hometown Urgent Care and Research
Dayton, Ohio, 45432, United States
RAS Health Ltd.
Marion, Ohio, 43302, United States
COR Clinical Research, LLC
Oklahoma City, Oklahoma, 73103, United States
McBride Clinic
Oklahoma City, Oklahoma, 73112, United States
Memorial Clinical Research
Oklahoma City, Oklahoma, 73134, United States
Pain Research of Oregon, LLC
Eugene, Oregon, 97401, United States
Medford Medical Clinic, LLP
Medford, Oregon, 97504, United States
Affinity Research
Portland, Oregon, 97219, United States
Lehigh Gastroenterology Associates
Allentown, Pennsylvania, 18104, United States
Albert Einstein Healthcare Network Einstein Pain Institute
Philadelphia, Pennsylvania, 19141, United States
Jeffry A. Lindenbaum DO, PC
Yardley, Pennsylvania, 19067, 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
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
Advanced Research Institute
Ogden, Utah, 84405, United States
Highland Clinical Research
Salt Lake City, Utah, 84124, United States
New River Valley Research Institute
Christiansburg, Virginia, 24073, United States
Digestive and Liver Disease Specialists
Norfolk, Virginia, 23502, United States
Hampton Roads Institution for Performance and Sports Medicine
Portsmouth, Virginia, 23707, United States
McGuire VA Medical Center
Richmond, Virginia, 23249, United States
Northwest Gastroenterology Associates
Bellevue, Washington, 98004, United States
VAMC Milwaukee
Milwaukee, Wisconsin, 53295, United States
Health Sciences Centre Pain Clinic
Winnipeg, Manitoba, R3A 1R9, Canada
AIM Health Group London North
London, Ontario, N5X 4E7, Canada
St. Michael's Hospital
Toronto, Ontario, M5B 1 W8, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- VP, Clinical Development
- Organization
- Sucampo Pharma Americas, LLC
Study Officials
- STUDY DIRECTOR
Global Clinical Leader
Mallinckrodt
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 11, 2008
First Posted
February 21, 2008
Study Start
December 1, 2007
Primary Completion
September 1, 2009
Study Completion
September 1, 2009
Last Updated
January 21, 2020
Results First Posted
December 30, 2019
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will not share