Opioid-induced Bowel Dysfunction: Long-Term Assessment of Lubiprostone
- Registration Number
- NCT00620061
- Lead Sponsor
- Sucampo Pharma Americas, LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 439
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description All Participants Lubiprostone 24 Lubiprostone: 24 mcg capsule twice daily (BID) for 36 weeks
- Primary Outcome Measures
Name Time Method Mean Weekly Bowel Movements (BMs) Per Month Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9 A Bowel Movement (BM) is defined as any BM (whether spontaneous or not)
Mean Weekly Spontaneous Bowel Movements (SBMs) Per Month Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9 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.
- Secondary Outcome Measures
Name Time Method Straining Associated With Spontaneous Bowel Movements by Month Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9 Participants rate the straining associated with the SBM on a scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe The highest score is 4, and lower scores are better.
Abdominal Discomfort by Month Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9 Participants rate their abdominal discomfort on a scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe.
The highest score is 4, but the best score is 0.Treatment Effectiveness by Month Months 1, 2, 3, 4, 5, 6, 7, 8, and 9 Participants rate treatment effectiveness on a scale where 0 = not at all effective, 1 = a little bit effective, 2 = moderately effective, 3 = quite a bit effective, 4 = extremely effective.
The highest and best score is 4.Number of Participants Classified as Monthly Responders Months 1, 2, 3, 4, 5, 6, 7, 8, and 9 A weekly SBM frequency rate is calculated as (168 x Number of SBMs / Number of hours observed).
A participant with an SBM frequency rate between 3 and 4 was considered a moderate responder. A subject with an SBM frequency rate higher than 4 was considered a full responder. If a subject was a moderate responder or full responder for at least half the weeks in a month, then he or she was considered a monthly responder.Stool Consistency of Spontaneous Bowel Movements by Month Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9 Participants rate each spontaneous bowel movement on a scale where 0 = very loose, 1 = loose, 2 = normal, 3 = hard, 4 = very hard (little balls) The highest score is 4, but the best score is 2.
Constipation Severity by Month Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9 Participants rate the severity of their constipation on a scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe.
The highest score is 4, but the best score is 0.Abdominal Bloating by Month Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9 Participants rate their bloating on a scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe.
The highest score is 4, but the best score is 0.Bowel Habit Regularity by Month Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9 Participants rate their bowel habit regularity on a balanced scale of 1 to 7 where 1=Very Regular and 7=Very Irregular.
The highest score is 7, but the best score is 1.Mean Weekly Complete SBMs by Month Months 1, 2, 3, 4, 5, 6, 7, 8, and 9 Participants rate each SBM as complete if their bowels feel completely empty after the SBM
Mean Weekly Complete BMs by Month Months 1, 2, 3, 4, 5, 6, 7, 8, and 9 Participants rate each BM as complete if their bowels feel completely empty after the BM
Trial Locations
- Locations (119)
Clinical Research Advantage, Inc.
🇺🇸Tempe, Arizona, United States
Advanced Clinical Research Institute
🇺🇸Anaheim, California, United States
Orange County Clinical Trials
🇺🇸Anaheim, California, United States
Loma Linda University
🇺🇸Loma Linda, California, United States
Pinnacle Trials Inc.
🇺🇸Atlanta, Georgia, United States
Drug Studies America
🇺🇸Marietta, Georgia, United States
Jeffry A. Lindenbaum DO, PC
🇺🇸Yardley, Pennsylvania, United States
Hampton Roads Institution for Performance and Sports Medicine
🇺🇸Portsmouth, Virginia, United States
Davis Clinic, PC
🇺🇸Indianapolis, Indiana, United States
Impact Clinical Trials
🇺🇸Las Vegas, Nevada, United States
Rider Research Group
🇺🇸San Francisco, California, United States
Affiliated Clinical Research, Inc.
🇺🇸Las Vegas, Nevada, United States
New River Valley Research Institute
🇺🇸Christiansburg, Virginia, United States
HOPE Research Institute
🇺🇸Phoenix, Arizona, United States
McBride Clinic
🇺🇸Oklahoma City, Oklahoma, United States
Virtua Lumberton Family Physicians
🇺🇸Lumberton, New Jersey, United States
Advanced Diagnostic Pain Treatment Center
🇺🇸New Haven, Connecticut, United States
Clinical Research Advantage, Inc. / East Valley Family Physicians, PLC
🇺🇸Tempe, Arizona, United States
Genova Clinical Research
🇺🇸Tucson, Arizona, United States
Holy Name Hospital
🇺🇸Teaneck, New Jersey, United States
Clinical Research Advantage, Inc./ Mesa Family Medical Center
🇺🇸Mesa, Arizona, United States
Premiere Pharamaceutical Research, LLC
🇺🇸Tempe, Arizona, United States
Gastroenterology Research Associates, LLC
🇺🇸Cedar Knolls, New Jersey, United States
Office of Stephen H. Miller, MD
🇺🇸Las Vegas, Nevada, United States
Wilson and Charani
🇺🇸Tucson, Arizona, United States
Teton Research, LLC
🇺🇸Little Rock, Arkansas, United States
Central Jersey Medical Research Center
🇺🇸Elizabeth, New Jersey, United States
Advanced Clinical Therapeutics, LLC
🇺🇸Tucson, Arizona, United States
Quality of Life Medical & Research Center, LLC
🇺🇸Tucson, Arizona, United States
Integrity Clinical Research, LLC
🇺🇸Milan, Tennessee, United States
The Birmingham Pain Center
🇺🇸Birmingham, Alabama, United States
Hometown Urgent Care and Research
🇺🇸Dayton, Ohio, United States
Carolina Research
🇺🇸Greenville, North Carolina, United States
Albert Einstein Healthcare Network Einstein Pain Institute
🇺🇸Philadelphia, Pennsylvania, United States
Lehigh Gastroenterology Associates
🇺🇸Allentown, Pennsylvania, United States
NYU Pain Management Center
🇺🇸New York, New York, United States
COR Clinical Research, LLC
🇺🇸Oklahoma City, Oklahoma, United States
Comprehensive Pain Specialists, PLLC
🇺🇸Hendersonville, Tennessee, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Peters Medical Research, LLC
🇺🇸High Point, North Carolina, United States
The Center for Clinical Research
🇺🇸Winston-Salem, North Carolina, United States
RAS Health Ltd.
🇺🇸Marion, Ohio, United States
The Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
Southeastern Clinical Research
🇺🇸Chattanooga, Tennessee, United States
Advanced Research Institute
🇺🇸Ogden, Utah, United States
DCOL Center for Clinical Research
🇺🇸Longview, Texas, United States
Glenway Family Medicine
🇺🇸Cincinnati, Ohio, United States
Medford Medical Clinic, LLP
🇺🇸Medford, Oregon, United States
Memorial Clinical Research
🇺🇸Oklahoma City, Oklahoma, United States
Pain Research of Oregon, LLC
🇺🇸Eugene, Oregon, United States
Texas Familicare Clinical Research
🇺🇸Hurst, Texas, United States
Trident Institute of Medical Research, LLC
🇺🇸North Charleston, South Carolina, United States
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
McGuire VA Medical Center
🇺🇸Richmond, Virginia, United States
Health Sciences Centre Pain Clinic
🇨🇦Winnipeg, Manitoba, Canada
AIM Health Group London North
🇨🇦London, Ontario, Canada
Affinity Research
🇺🇸Portland, Oregon, United States
Simon Williamson Clinic, PC
🇺🇸Hueytown, Alabama, United States
Alabama Orthopedic Clinic
🇺🇸Mobile, Alabama, United States
Verona Clinical Research, Inc.
🇺🇸Tucson, Arizona, United States
Redpoint Research
🇺🇸Phoenix, Arizona, United States
Northern California Research Corporation
🇺🇸Sacramento, California, United States
Arkansas Pain Research
🇺🇸Hot Springs, Arkansas, United States
Stedman Clinical Trials
🇺🇸Tampa, Florida, United States
Millenium Pain Center
🇺🇸Bloomington, Illinois, United States
Clinical Physiology Associates/Clinical Study Center
🇺🇸Fort Myers, Florida, United States
Drug Study Institute
🇺🇸Jupiter, Florida, United States
Palm Beach Research Center
🇺🇸West Palm Beach, Florida, United States
North Georgia Premier Research
🇺🇸Dawsonville, Georgia, United States
Best Clinical Research
🇺🇸Decatur, Georgia, United States
Apex Medical Research, AMR, Inc
🇺🇸Chicago, Illinois, United States
Redhead Research Inc.
🇺🇸Peoria, Illinois, United States
MediSphere Medical Research Center, LLC
🇺🇸Evansville, Indiana, United States
The Pain Treatment Center of the Bluegrass
🇺🇸Lexington, Kentucky, United States
Louisiana Research Center, LLC
🇺🇸Shreveport, Louisiana, United States
Medical Research Associates
🇺🇸Traverse City, Michigan, United States
Intergrated Clinical Trial Services, Inc
🇺🇸West Des Moines, Iowa, United States
Brigham and Women's Hosptial
🇺🇸Chestnut Hill, Massachusetts, United States
Professional Clinical Research - Interlochen
🇺🇸Interlochen, Michigan, United States
Beyer Research
🇺🇸Kalamazoo, Michigan, United States
The Willis-Knighton Interventional Pain Center
🇺🇸Shreveport, Louisiana, United States
Columbia Medical Practice/ RxTrials, Inc.
🇺🇸Columbia, Maryland, United States
Long Island Gastrointestinal Research Group
🇺🇸Great Neck, New York, United States
Center for Clinical Studies
🇺🇸Dearborn, Michigan, United States
Montana Neuroscience Institute Foundation / Montana Spine and Pain Center
🇺🇸Missoula, Montana, United States
MedVadis Research Corporation
🇺🇸Wellesley Hills, Massachusetts, United States
University of Rochester, Pain Treatment Center
🇺🇸Rochester, New York, United States
Research Across America
🇺🇸New York, New York, United States
Apex Medical Research, AMR, Inc.
🇺🇸Flint, Michigan, United States
Ladder Family Practice
🇺🇸Las Vegas, Nevada, United States
VAMC Milwaukee
🇺🇸Milwaukee, Wisconsin, United States
Highland Clinical Research
🇺🇸Salt Lake City, Utah, United States
Upstate Clinical Research Associates
🇺🇸Williamsville, New York, United States
Paradigm Clinical Research, Inc.
🇺🇸Tucson, Arizona, United States
University of Illinois at Chicago: Department of Medicine
🇺🇸Chicago, Illinois, United States
Northwest Gastroenterology Associates
🇺🇸Bellevue, Washington, United States
Digestive and Liver Disease Specialists
🇺🇸Norfolk, Virginia, United States
Advanced Pain Institute
🇺🇸Arcadia, California, United States
Pasadena Rehabilitation Institute
🇺🇸Pasadena, California, United States
RX Clinical Research, Inc.
🇺🇸Garden Grove, California, United States
ShahShreenath Clinical Service
🇺🇸Yorba Linda, California, United States
International Medical Research
🇺🇸Daytona Beach, Florida, United States
Lynn Institute of the Rockies
🇺🇸Colorado Springs, Colorado, United States
Century Clinical Research Inc
🇺🇸Daytona Beach, Florida, United States
Clinicos, LLC
🇺🇸Colorado Springs, Colorado, United States
Meridien Research
🇺🇸Saint Petersburg, Florida, United States
Southeastern Integrated Medical, PL dba Florida
🇺🇸Gainesville, Florida, United States
Sunrise Medical Research, Inc.
🇺🇸Lauderdale Lakes, Florida, United States
Century Clinical Research
🇺🇸Holly Hill, Florida, United States
Florida Institute of Medical Research
🇺🇸Jacksonville, Florida, United States
North Miami Research Inc.
🇺🇸North Miami, Florida, United States
Kenneth W. Ponder, MD, PA
🇺🇸Niceville, Florida, United States
DMI Health Care Group, Inc.
🇺🇸Pinellas Park, Florida, United States
Accord Clinical Research, LLC
🇺🇸Port Orange, Florida, United States
Clinical Research of West Florida, Inc.
🇺🇸Tampa, Florida, United States
Medex Healthcare Research Inc.
🇺🇸Saint Louis, Missouri, United States
Pain and Rehabilitation Medicine
🇺🇸Bethesda, Maryland, United States
MAPS Applied Research Center
🇺🇸Edina, Minnesota, United States
Center for Digestive Health
🇺🇸Troy, Michigan, United States