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

The purpose of this study is to evaluate the long-term safety and efficacy of lubiprostone administration in participants with opioid-induced bowel dysfunction.

Study Overview

• Status: Completed
• Conditions: Opioid-Induced Bowel Dysfunction
• Intervention / Treatment: Drug: Lubiprostone 24

• Study Type: Interventional
• Enrollment (Actual): 439
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3A 1R9
      • Health Sciences Centre Pain Clinic
  • Ontario
    • London, Ontario, Canada, N5X 4E7
      • AIM Health Group London North
    • Toronto, Ontario, Canada, M5B 1 W8
      • St. Michael's Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35242
      • The Birmingham Pain Center
    • Hueytown, Alabama, United States, 35023
      • Simon Williamson Clinic, PC
    • Mobile, Alabama, United States, 36608
      • Alabama Orthopedic Clinic
  • Arizona
    • Mesa, Arizona, United States, 85203
      • Clinical Research Advantage, Inc./ Mesa Family Medical Center
    • Phoenix, Arizona, United States, 85029
      • Redpoint Research
    • Phoenix, Arizona, United States, 85050
      • Hope Research Institute
    • Phoenix, Arizona, United States, 85128
      • Clinical Research Advantage, Inc.
    • Tempe, Arizona, United States, 85282
      • Clinical Research Advantage, Inc.
    • Tempe, Arizona, United States, 85222
      • Clinical Research Advantage, Inc. / East Valley Family Physicians, PLC
    • Tempe, Arizona, United States, 85282
      • Premiere Pharamaceutical Research, LLC
    • Tucson, Arizona, United States, 85712
      • Quality of Life Medical & Research Center, LLC
    • Tucson, Arizona, United States, 85704
      • Genova Clinical Research
    • Tucson, Arizona, United States, 85712
      • Advanced Clinical Therapeutics, LLC
    • Tucson, Arizona, United States, 85710
      • Verona Clinical Research, Inc.
    • Tucson, Arizona, United States, 85712
      • Paradigm Clinical Research, Inc.
    • Tucson, Arizona, United States, 85741
      • Wilson and Charani
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • Arkansas Pain Research
    • Little Rock, Arkansas, United States, 72205
      • Teton Research, LLC
  • California
    • Anaheim, California, United States, 92801
      • Advanced Clinical Research Institute
    • Anaheim, California, United States, 92801
      • Orange County Clinical Trials
    • Arcadia, California, United States, 91007
      • Advanced Pain Institute
    • Beverly Hills, California, United States, 90036
      • Impact Clinical Trials
    • Garden Grove, California, United States, 92843
      • RX Clinical Research, Inc.
    • Garden Grove, California, United States, 92840
      • Digestive and Liver Disease Specialists
    • Loma Linda, California, United States, 92354
      • Loma Linda University
    • Pasadena, California, United States, 91105
      • Pasadena Rehabilitation Institute
    • Sacramento, California, United States, 95831
      • Northern California Research Corporation
    • San Francisco, California, United States, 94117
      • Rider Research Group
    • Yorba Linda, California, United States, 92886
      • ShahShreenath Clinical Service
  • Colorado
    • Colorado Springs, Colorado, United States, 80904
      • Clinicos, LLC
    • Colorado Springs, Colorado, United States, 80907
      • Lynn Institute Of The Rockies
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Advanced Diagnostic Pain Treatment Center
  • Florida
    • Brooksville, Florida, United States, 34601
      • Meridien Research
    • Daytona Beach, Florida, United States, 32117
      • International Medical Research
    • Daytona Beach, Florida, United States, 32117
      • Century Clinical Research Inc
    • Fort Myers, Florida, United States, 33916
      • Clinical Physiology Associates/Clinical Study Center
    • Gainesville, Florida, United States, 32607
      • Southeastern Integrated Medical, PL dba Florida
    • Holly Hill, Florida, United States, 32117
      • Century Clinical Research
    • Jacksonville, Florida, United States, 32257
      • Florida Institute of Medical Research
    • Jupiter, Florida, United States, 33458
      • Drug Study Institute
    • Lauderdale Lakes, Florida, United States, 33319
      • Sunrise Medical Research, Inc.
    • Niceville, Florida, United States, 32578
      • Kenneth W. Ponder, MD, PA
    • North Miami, Florida, United States, 33161
      • North Miami Research Inc.
    • Pinellas Park, Florida, United States, 33782
      • DMI Health Care Group, Inc.
    • Port Orange, Florida, United States, 32129
      • Accord Clinical Research, LLC
    • Saint Petersburg, Florida, United States, 33709
      • Meridien Research
    • Tampa, Florida, United States, 33613
      • Stedman Clinical Trials
    • Tampa, Florida, United States, 33603
      • Clinical Research of West Florida, Inc.
    • West Palm Beach, Florida, United States, 33409
      • Palm Beach Research Center
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Pinnacle Trials Inc.
    • Dawsonville, Georgia, United States, 30534
      • North Georgia Premier Research
    • Decatur, Georgia, United States, 30034
      • Best Clinical Research
    • Marietta, Georgia, United States, 30060
      • Drug Studies America
  • Illinois
    • Bloomington, Illinois, United States, 61701
      • Millenium Pain Center
    • Chicago, Illinois, United States, 60616
      • Apex Medical Research, AMR, Inc
    • Chicago, Illinois, United States, 60612
      • University of Illinois at Chicago: Department of Medicine
    • Peoria, Illinois, United States, 161614
      • Redhead Research Inc.
  • Indiana
    • Evansville, Indiana, United States, 47714
      • Medisphere Medical Research Center, Llc
    • Indianapolis, Indiana, United States, 46260
      • Davis Clinic, PC
  • Iowa
    • West Des Moines, Iowa, United States, 50265
      • Intergrated Clinical Trial Services, Inc
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • The Pain Treatment Center of the Bluegrass
  • Louisiana
    • Shreveport, Louisiana, United States, 71103
      • Louisiana Research Center, LLC
    • Shreveport, Louisiana, United States, 71105
      • The Willis-Knighton Interventional Pain Center
  • Maryland
    • Bethesda, Maryland, United States, 20814
      • Pain and Rehabilitation Medicine
    • Columbia, Maryland, United States, 21045
      • Columbia Medical Practice/ RxTrials, Inc.
  • Massachusetts
    • Chestnut Hill, Massachusetts, United States, 02467
      • Brigham and Women's Hosptial
    • Wellesley Hills, Massachusetts, United States, 02481
      • MedVadis Research Corporation
  • Michigan
    • Dearborn, Michigan, United States, 48124
      • Center For Clinical Studies
    • Flint, Michigan, United States, 48504
      • Apex Medical Research, AMR, Inc.
    • Interlochen, Michigan, United States, 49641
      • Professional Clinical Research - Interlochen
    • Kalamazoo, Michigan, United States, 49009
      • Beyer Research
    • Traverse City, Michigan, United States, 49684
      • Medical Research Associates
    • Troy, Michigan, United States, 48098
      • Center for Digestive Health
  • Minnesota
    • Edina, Minnesota, United States, 55435
      • MAPS Applied Research Center
  • Missouri
    • Saint Louis, Missouri, United States, 63117
      • Medex Healthcare Research Inc.
  • Montana
    • Missoula, Montana, United States, 59802
      • Montana Neuroscience Institute Foundation / Montana Spine and Pain Center
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Office of Stephen H. Miller, MD
    • Las Vegas, Nevada, United States, 89144
      • Affiliated Clinical Research, Inc.
    • Las Vegas, Nevada, United States, 89146
      • Ladder Family Practice
    • Las Vegas, Nevada, United States, 89206
      • Impact Clinical Trials
  • New Jersey
    • Cedar Knolls, New Jersey, United States, 07927
      • Gastroenterology Research Associates, LLC
    • Elizabeth, New Jersey, United States, 07202
      • Central Jersey Medical Research Center
    • Lumberton, New Jersey, United States, 08048
      • Virtua Lumberton Family Physicians
    • Teaneck, New Jersey, United States, 07666
      • Holy Name Hospital
  • New York
    • Great Neck, New York, United States, 11023
      • Long Island Gastrointestinal Research Group
    • New York, New York, United States, 10022
      • Research Across America
    • New York, New York, United States, 10016
      • NYU Pain Management Center
    • Rochester, New York, United States, 14642
      • University of Rochester, Pain Treatment Center
    • Williamsville, New York, United States, 14221
      • Upstate Clinical Research Associates
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University Medical Center
    • Greenville, North Carolina, United States, 27834
      • Carolina Research
    • High Point, North Carolina, United States, 27262
      • Peters Medical Research, LLC
    • Winston-Salem, North Carolina, United States, 27103
      • The Center for Clinical Research
  • Ohio
    • Cincinnati, Ohio, United States, 45238
      • Glenway Family Medicine
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Medical Center
    • Dayton, Ohio, United States, 45432
      • Hometown Urgent Care and Research
    • Marion, Ohio, United States, 43302
      • RAS Health Ltd.
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
      • COR Clinical Research, LLC
    • Oklahoma City, Oklahoma, United States, 73134
      • Memorial Clinical Research
    • Oklahoma City, Oklahoma, United States, 73112
      • McBride Clinic
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Pain Research of Oregon, LLC
    • Medford, Oregon, United States, 97504
      • Medford Medical Clinic, LLP
    • Portland, Oregon, United States, 97219
      • Affinity Research
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18104
      • Lehigh Gastroenterology Associates
    • Philadelphia, Pennsylvania, United States, 19141
      • Albert Einstein Healthcare Network Einstein Pain Institute
    • Yardley, Pennsylvania, United States, 19067
      • Jeffry A. Lindenbaum DO, PC
  • South Carolina
    • North Charleston, South Carolina, United States, 29406
      • Trident Institute of Medical Research, LLC
  • Tennessee
    • Chattanooga, Tennessee, United States, 37403
      • Southeastern Clinical Research
    • Hendersonville, Tennessee, United States, 37075
      • Comprehensive Pain Specialists, PLLC
    • Milan, Tennessee, United States, 38358
      • Integrity Clinical Research, LLC
  • Texas
    • Hurst, Texas, United States, 76054
      • Texas Familicare Clinical Research
    • Longview, Texas, United States, 75605
      • DCOL Center for Clinical Research
  • Utah
    • Ogden, Utah, United States, 84405
      • Advanced Research Institute
    • Salt Lake City, Utah, United States, 84124
      • Highland Clinical Research
  • Virginia
    • Christiansburg, Virginia, United States, 24073
      • New River Valley Research Institute
    • Norfolk, Virginia, United States, 23502
      • Digestive and Liver Disease Specialists
    • Portsmouth, Virginia, United States, 23707
      • Hampton Roads Institution for Performance and Sports Medicine
    • Richmond, Virginia, United States, 23249
      • McGuire VA Medical Center
  • Washington
    • Bellevue, Washington, United States, 98004
      • Northwest Gastroenterology Associates
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53295
      • VAMC Milwaukee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: All Participants; Lubiprostone: 24 mcg capsule twice daily (BID) for 36 weeks	Drug: Lubiprostone 24; 24 mcg capsules for oral administration; Other Names: Amitiza

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Classified as Monthly Responders	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.	Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
Straining Associated With Spontaneous Bowel Movements by Month	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.	Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
Stool Consistency of Spontaneous Bowel Movements by Month	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.	Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
Constipation Severity by Month	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.	Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
Abdominal Bloating by Month	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.	Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
Abdominal Discomfort by Month	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.	Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
Bowel Habit Regularity by Month	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.	Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
Treatment Effectiveness by Month	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.	Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
Mean Weekly Complete SBMs by Month	Participants rate each SBM as complete if their bowels feel completely empty after the SBM	Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
Mean Weekly Complete BMs by Month	Participants rate each BM as complete if their bowels feel completely empty after the BM	Months 1, 2, 3, 4, 5, 6, 7, 8, and 9

Collaborators and Investigators

• Sponsor: Sucampo Pharma Americas, LLC

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2007
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: February 11, 2008
• First Submitted That Met QC Criteria: February 20, 2008
• First Posted (Estimate): February 21, 2008

Study Record Updates

• Last Update Posted (Actual): January 21, 2020
• Last Update Submitted That Met QC Criteria: January 10, 2020
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Digestive System Diseases; Substance-Related Disorders; Signs and Symptoms, Digestive; Narcotic-Related Disorders; Constipation; Gastrointestinal Diseases; Intestinal Diseases; Opioid-Induced Constipation; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Chloride Channel Agonists; Lubiprostone
• Other Study ID Numbers: OBD06S1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO