Opioid-induced Bowel Dysfunction (OBD) Pivotal Assessment of Lubiprostone (OPAL)

February 3, 2020 updated by: Sucampo Pharma Americas, LLC

A Multicenter, Randomized, Placebo-controlled, Double-blinded Study of the Efficacy and Safety of Lubiprostone in Subjects With Opioid-induced Bowel Dysfunction

The primary purpose of the study is to evaluate the efficacy and safety of lubiprostone administration in subjects with Opioid-induced Bowel Dysfunction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

439

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerp, Belgium, 2100
        • Huisartsenpraktijk De Regenboog
      • Wetteren, Belgium, 9230
        • Dr Capiau - GP Practice
    • Westlaan 123
      • Roeselare, Westlaan 123, Belgium, 8800
        • Pain Clinic-Heilig Hart Ziekenhuis Roeselare
  • Czechia
      • Brno, Czechia, 656 91
        • St. Anne's University Hospital - centrum pro
      • Jablonec nad Nisou, Czechia, 466 60
        • Nemocnice Jablonec nad Nisou, p.o.
      • Liberec, Czechia, 460 63
        • Ambulance bolesti, Krajska nemocnice Liberec
      • Mlada Boleslav, Czechia, 293 50
        • Klaudianova nemocnice Mlada Boleslav
      • Praha 10, Czechia, 108 00
        • CLINTRIAL s.r.o.
      • Praha 6, Czechia, 160 00
        • Neurologicka ambulance
      • Zlin, Czechia, 762 75
        • Regional Hospital T. B., a.s.
  • Germany
      • Berlin, Germany, 10435
        • Schmerzzentrum Berlin
      • Hannover, Germany, 30167
        • Schmerztherapeutische- Ärztezentrum Nordstadt
      • Wiesbaden, Germany, 65189
        • Schmerz und Palliativzentrum
  • Poland
      • Bydgoszcz, Poland, 85-796
        • NZOZ Dom Sue Ryder prowadzony przez Pallmed Sp. z o.o.
  • Sweden
      • Gothenburg, Sweden, 13 28
        • Hagakliniken
      • Stockholm, Sweden, 4186
        • Karolinska University Hospita- Dept of Anaesthesia, Pain Div.
      • Vällingby, Sweden, Stockholm 162 68
        • S3 Clinical Research Centers
  • United Kingdom
      • Dunfermline, United Kingdom, KY12 8SJ
        • Valleyfield Health Center
      • Frome, United Kingdom, BA11 1EZ
        • Frome Medical Practice
      • Reading, United Kingdom, RG7 3SG
        • Mortimer Surgery
    • Cardiff
      • ELY, Cardiff, United Kingdom, CF5 4AE
        • ElyBridge Surgery
    • Co Antrim
      • Randalstown, Co Antrim, United Kingdom, BT41 3AE
        • Randalstown Medical Practice
    • E.Sussex
      • Bexhill on Sea, E.Sussex, United Kingdom, TN40 1JJ
        • Sea Road Surgery
    • Herts
      • Watford, Herts, United Kingdom, WD25 0EA
        • Sheepcot Medical Centre,
    • Lancsashire
      • Blackpool, Lancsashire, United Kingdom, FY3 7EN
        • Fylde Coast Clinical Research Ltd
    • Northern Ireland
      • Belfast, Northern Ireland, United Kingdom, BT13 3BW
        • Ballygomartin Group Practice
    • Wales
      • Barry, Wales, United Kingdom, CF63 4AR
        • The Waterfront Medical Centre
  • United States
    • Alabama
      • Athens, Alabama, United States, 35811
        • North Alabama Research Center
      • Birmingham, Alabama, United States, 35216
        • Achieve Clinical Research
      • Birmingham, Alabama, United States, 35235
        • Alabama Clinical Therapeutics
      • Birmingham, Alabama, United States, 35205
        • Innovative Clinical Trials, Inc.
      • Foley, Alabama, United States, 36535
        • G&L Research, LLC
      • Montgomery, Alabama, United States, 36109
        • Healthscan Research
      • Tallassee, Alabama, United States, 36078
        • River Region Research
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Anasazi Internal Medicine PC
    • Arkansas
      • Little Rock, Arkansas, United States, 72212
        • Aureas Research, Inc
    • California
      • Carmichael, California, United States, 95608
        • Certified Clinical Research
      • Davis, California, United States, 95616
        • California Clinical Research, Inc.
      • Foothill Ranch, California, United States, 92610
        • Family Medical Center
      • Laguna Hills, California, United States, 92653
        • South Orange County Surgical Medical Group
      • Lincoln, California, United States, 95648
        • Clinical Trials Research
      • Long Beach, California, United States, 90822
        • Long Beach VA Medical Center
      • Long Beach, California, United States, 90805
        • Clear Vision Research
      • Los Angeles, California, United States, 90023
        • Clear Vision Research
      • Mission Hills, California, United States, 91345
        • FACEY Medical Foundation
      • Oceanside, California, United States, 92056
        • North County Clinical Research
      • Orange, California, United States, 92868
        • SDS Clinical Trials, Inc.
      • Riverside, California, United States, 92501
        • Probe Clinical Research Corporation
      • Santa Ana, California, United States, 92701
        • Probe Clinical Research Corporation - Santa Ana
      • Westlake Village, California, United States, 91361
        • Westlake Medical Research
    • Colorado
      • Denver, Colorado, United States, 80209
        • Mountain View Clinical Research
    • Florida
      • Bradenton, Florida, United States, 34208
        • Meridien Research
      • Bradenton, Florida, United States, 34209
        • Coastal Orthopedics & Pain Management
      • Clearwater, Florida, United States, 33755
        • Florida Research & Testing, LLC
      • DeLand, Florida, United States, 32720
        • Avail Clinical Research
      • Fort Lauderdale, Florida, United States, 33306
        • S&W Clinical Research
      • Hialeah, Florida, United States, 33012
        • Palm Springs Research Institute
      • Miami, Florida, United States, 33175
        • Kendall South Medical Center, Inc.
      • Naples, Florida, United States, 34102
        • Gastroenterology Group Of Naples
      • Naples, Florida, United States, 34119
        • Physicians Regional Medical Group
      • Ocala, Florida, United States, 34474
        • Ocala Rheumatology Research Center
      • Ocala, Florida, United States, 34474
        • Paddock Park Clinical Research
      • Oldsmar, Florida, United States, 34677
        • Journey Research, Inc.
      • Orlando, Florida, United States, 32806
        • Compass Research
      • Pembroke Pines, Florida, United States, 30026
        • Andres Patron, DO, PA
      • Pinellas Park, Florida, United States, 33781
        • Advent Clinical Research Centers
      • Plantation, Florida, United States, 33317
        • Gold Coast Research, LLC
      • Royal Palm Beach, Florida, United States, 33411
        • Orthopedic Research Institite
      • Sanford, Florida, United States, 32771
        • IC Research
      • Sarasota, Florida, United States, 34238
        • Sarasota Memorial Pain Care Center
      • Tampa, Florida, United States, 33624
        • Tampa Clinical Research
    • Georgia
      • Columbus, Georgia, United States, 31904
        • Southeastern Regional Research Group
      • Newnan, Georgia, United States, 30265
        • Better Health Clinical Research
      • Stockbridge, Georgia, United States, 30281
        • Clinical Research Atlanta
    • Idaho
      • Boise, Idaho, United States, 83702
        • Sonora Clinical Research
      • Boise, Idaho, United States, 83642
        • Advanced Clinical Research
      • Meridian, Idaho, United States, 83642
        • Nautical Clinical Research
    • Illinois
      • Chicago, Illinois, United States, 60657
        • Anesthesia/Pain Control Indiana University School of Medicine
      • Peoria, Illinois, United States, 61614
        • Knight Center for Integrated Health
    • Iowa
      • Council Bluffs, Iowa, United States, 51503
        • Ridge Family Practice
    • Kansas
      • Lenexa, Kansas, United States, 66215
        • Lee Research Institute
    • Kentucky
      • Lexington, Kentucky, United States, 40504
        • Kentucky Medical Research Center
      • Owensboro, Kentucky, United States, 42303
        • Bluegrass Internal Medicine
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Horizon Research Group
    • Massachusetts
      • Brockton, Massachusetts, United States, 02301
        • Miray Medical Center
      • Springfield, Massachusetts, United States, 01107
        • The Research Institute
      • Weymouth, Massachusetts, United States, 02190
        • Coastal Research
    • Michigan
      • Dearborn, Michigan, United States, 48124
        • Ashok Jain, MD
      • Saint Clair Shores, Michigan, United States, 48081
        • Shores Medical Associates
    • Missouri
      • Saint Louis, Missouri, United States, 63139
        • Mid-America Clinical Research LLC
    • Montana
      • Missoula, Montana, United States, 59808
        • Montana Medical Research, Inc.
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • AB Clinical Trials
      • Las Vegas, Nevada, United States, 89121
        • Clinical Research of South Nevada
      • Las Vegas, Nevada, United States, 89128
        • Clinical Research Advantage, Inc.
      • Las Vegas, Nevada, United States, 89106
        • Independent Clinical Researchers
      • Las Vegas, Nevada, United States, 89149
        • Lab2Marche
      • Las Vegas, Nevada, United States, 89183
        • Aloha Medical Center
    • New Jersey
      • Edison, New Jersey, United States, 08817
        • Edison Medical Group
      • Marlton, New Jersey, United States, 08053
        • Clinical Research Program
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Albuquerque Clinical Trials
    • New York
      • Hartsdale, New York, United States, 10530
        • Drug Trials America
      • Jamestown, New York, United States, 14701
        • Family Health Medical Services PLLC
      • Rochester, New York, United States, 14618
        • U of Rochester
    • Ohio
      • Carlisle, Ohio, United States, 45005
        • Medical Frontiers
      • Cincinnati, Ohio, United States, 45227
        • Community Research
      • Cincinnati, Ohio, United States, 45245
        • Community Research
      • Cincinnati, Ohio, United States, 45224
        • Hightop Medical Research Center
      • Cleveland, Ohio, United States, 44122
        • Rapid Medical Research, Inc.
      • Columbus, Ohio, United States, 43207
        • Parsons Avenue Medical Center
      • Groveport, Ohio, United States, 43125
        • Hometown Urgent Care
      • Middleburg Heights, Ohio, United States, 44130
        • Northstar Medical Research, LLC
      • Zanesville, Ohio, United States, 43701
        • Pharmacotherpy Research Associates Inc
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • COR Clinical Research, LLC
      • Oklahoma City, Oklahoma, United States, 73112
        • Sooner Clinical Research
    • Oregon
      • Medford, Oregon, United States, 97504
        • Sunstone Medical Research
      • Portland, Oregon, United States, 97219
        • Fanno Creek Clinic
    • Pennsylvania
      • Mechanicsburg, Pennsylvania, United States, 17055
        • McMillen & Magargle
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • Omega Medical Research
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Hartwell Research Group
      • Greer, South Carolina, United States, 29651
        • DeGarmo Institute of Medical Research
      • North Charleston, South Carolina, United States, 29406
        • Pain Specialists of Charleston
    • South Dakota
      • Rapid City, South Dakota, United States, 57702
        • Health Concepts
    • Tennessee
      • Brentwood, Tennessee, United States, 37027
        • InvestiClin Research
      • Germantown, Tennessee, United States, 38138
        • SCRI Research Center
      • Humboldt, Tennessee, United States, 38343
        • Prevention & Strengthening Solutions, Inc.
    • Texas
      • Austin, Texas, United States, 78756
        • FutureSearch Trials of Neurology & Sleep Lab
      • Austin, Texas, United States, 78757
        • Jaron Winston, MD
      • Dallas, Texas, United States, 75231
        • FutureSearch Trials of Dallas, LP
      • Dallas, Texas, United States, 75230
        • KRK Medical Research
      • Dallas, Texas, United States, 75251
        • Galenos Research
      • Dallas, Texas, United States, 75243
        • Pillar Clinical Research, LLC
      • Houston, Texas, United States, 77098
        • Pioneer Research Solutions, Inc.
      • Houston, Texas, United States, 77074
        • Clinical Trial Network
      • Houston, Texas, United States, 77027
        • Diversified Medical Practice, P.A.
      • Houston, Texas, United States, 77074
        • Dependable Clinical Research
      • Richardson, Texas, United States, 75080
        • Bobby Huynh
      • San Antonio, Texas, United States, 78215
        • Sun Research Institute
      • Sugar Land, Texas, United States, 77478
        • Spring Clinical Research
      • Sugar Land, Texas, United States, 77479
        • Pioneer Research Solutions
    • Utah
      • Salt Lake City, Utah, United States, 84106
        • Lifetree Clinical Research
      • West Jordan, Utah, United States, 84088
        • ACR Research Salt Lake City
    • Virginia
      • Midlothian, Virginia, United States, 23114
        • Virginia Research Center, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

A patient can be considered for eligibility to participate if he/she:

  • Has been consistently treated for chronic, noncancer-related pain with any oral, transdermal, intravenous, or subcutaneous opioid for at least 30 days prior to screening
  • Is diagnosed with OBD
  • Is capable of utilizing an electronic diary to report daily spontaneous bowel movements (SBMs)
  • Is willing to continue opioid therapy and discontinue the use of laxatives, stool softeners, and other concomitant medications affecting gastrointestinal motility throughout the study

Exclusion Criteria:

A patient cannot be considered for eligibility to participate if he/she:

  • Uses opioids for the treatment of cancer-related pain, abdominal pain, mechanical bowel obstructions, bowel disorders, and constipation not arising from opioid use, but instead attributable to dietary, neurologic, congenital, or endocrine disorders, scleroderma, and/or for the management of drug addiction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lubiprostone
24 mcg capsules twice daily (BID)
Drug: Lubiprostone
24 mcg administered orally twice daily (BID)
Other Names:
  • Amitiza
Placebo Comparator: Placebo
0 mcg capsules twice daily (BID)
Drug: Placebo
Matching placebo, 0 mcg administered orally twice daily (BID)
Other Names:
  • No other names

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Classified as Treatment Responders Within 12 Weeks
Time Frame: 12 weeks
Spontaneous bowel movement (SBM) is defined as any BM that does not occur within 24 hours after use of rescue medication. To be classified as responders, participants are required to demonstrate at least moderate response (≥ 1 SBM improvement over baseline SBM frequency) for all treatment weeks for which observed data are available, and must additionally demonstrate a full response (≥ 3 SBMs per week) for at least 9 of the 12 treatment weeks.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of SBMs Per Week at Week 8
Time Frame: at Week 8
at Week 8
Number of Participants Who Experienced First SBM Within 48 Hours After Dose Initiation
Time Frame: within 48 hours post-dose
within 48 hours post-dose
Number of SBMs Per Week at Week 12
Time Frame: at Week 12
at Week 12
Number of SBMs Per Week Overall
Time Frame: within 14 weeks
Overall is defined as the length of time from first dose to last follow-up within 2 weeks after last dose.
within 14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sucampo Pharma Americas, LLC

Collaborators

Sucampo Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

January 20, 2011

First Submitted That Met QC Criteria

February 15, 2011

First Posted (Estimate)

February 17, 2011

Study Record Updates

Last Update Posted (Actual)

February 11, 2020

Last Update Submitted That Met QC Criteria

February 3, 2020

Last Verified

February 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OBD1033

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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