Opioid-induced Bowel DysfunctionPhase 3NCT01298219
Opioid-induced Bowel Dysfunction (OBD) Pivotal Assessment of Lubiprostone (OPAL)
A Phase 3 study testing Lubiprostone in people with Opioid-induced Bowel Dysfunction, run by Sucampo Pharma Americas, LLC at 142 sites in 7 countries.
Trial summary
The primary purpose of the study is to evaluate the efficacy and safety of lubiprostone administration in subjects with Opioid-induced Bowel Dysfunction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid-induced Bowel Dysfunction
- What is being tested?
- Lubiprostone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 439 participants
- Where
- 142 sitesin 7 countries
- Study dates
- Dec 2010to Nov 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
142 sites in 7 countries.
142 sites in 7 countries
United States115 sites
Albuquerque Clinical Trials
Albuquerque, New Mexico, 87102
Hartwell Research Group
Anderson, South Carolina, 29621
North Alabama Research Center
Athens, Alabama, 35811
FutureSearch Trials of Neurology & Sleep Lab
Austin, Texas, 78756
Jaron Winston, MD
Austin, Texas, 78757
Horizon Research Group
Baton Rouge, Louisiana, 70809
Innovative Clinical Trials, Inc.
Birmingham, Alabama, 35205
Achieve Clinical Research
Birmingham, Alabama, 35216
Alabama Clinical Therapeutics
Birmingham, Alabama, 35235
Advanced Clinical Research
Boise, Idaho, 83642
Sonora Clinical Research
Boise, Idaho, 83702
Meridien Research
Bradenton, Florida, 34208
Coastal Orthopedics & Pain Management
Bradenton, Florida, 34209
InvestiClin Research
Brentwood, Tennessee, 37027
Miray Medical Center
Brockton, Massachusetts, 02301
Medical Frontiers
Carlisle, Ohio, 45005
Certified Clinical Research
Carmichael, California, 95608
Anesthesia/Pain Control Indiana University School of Medicine
Chicago, Illinois, 60657
Hightop Medical Research Center
Cincinnati, Ohio, 45224
Community Research
Cincinnati, Ohio, 45227
Community Research
Cincinnati, Ohio, 45245
Florida Research & Testing, LLC
Clearwater, Florida, 33755
Rapid Medical Research, Inc.
Cleveland, Ohio, 44122
Southeastern Regional Research Group
Columbus, Georgia, 31904
Parsons Avenue Medical Center
Columbus, Ohio, 43207
Ridge Family Practice
Council Bluffs, Iowa, 51503
KRK Medical Research
Dallas, Texas, 75230
FutureSearch Trials of Dallas, LP
Dallas, Texas, 75231
Pillar Clinical Research, LLC
Dallas, Texas, 75243
Galenos Research
Dallas, Texas, 75251
California Clinical Research, Inc.
Davis, California, 95616
Ashok Jain, MD
Dearborn, Michigan, 48124
Avail Clinical Research
DeLand, Florida, 32720
Mountain View Clinical Research
Denver, Colorado, 80209
Edison Medical Group
Edison, New Jersey, 08817
G&L Research, LLC
Foley, Alabama, 36535
Family Medical Center
Foothill Ranch, California, 92610
S&W Clinical Research
Fort Lauderdale, Florida, 33306
SCRI Research Center
Germantown, Tennessee, 38138
Degarmo Institute of Medical Research
Greer, South Carolina, 29651
Hometown Urgent Care
Groveport, Ohio, 43125
Drug Trials America
Hartsdale, New York, 10530
Palm Springs Research Institute
Hialeah, Florida, 33012
Diversified Medical Practice, P.A.
Houston, Texas, 77027
Clinical Trial Network
Houston, Texas, 77074
Dependable Clinical Research
Houston, Texas, 77074
Pioneer Research Solutions, Inc.
Houston, Texas, 77098
Prevention & Strengthening Solutions, Inc.
Humboldt, Tennessee, 38343
Family Health Medical Services PLLC
Jamestown, New York, 14701
South Orange County Surgical Medical Group
Laguna Hills, California, 92653
Independent Clinical Researchers
Las Vegas, Nevada, 89106
AB Clinical Trials
Las Vegas, Nevada, 89119
Clinical Research of South Nevada
Las Vegas, Nevada, 89121
Clinical Research Advantage, Inc.
Las Vegas, Nevada, 89128
Lab2Marche
Las Vegas, Nevada, 89149
Aloha Medical Center
Las Vegas, Nevada, 89183
Lee Research Institute
Lenexa, Kansas, 66215
Kentucky Medical Research Center
Lexington, Kentucky, 40504
Clinical Trials Research
Lincoln, California, 95648
Aureas Research, Inc
Little Rock, Arkansas, 72212
Clear Vision Research
Long Beach, California, 90805
Long Beach VA Medical Center
Long Beach, California, 90822
Clear Vision Research
Los Angeles, California, 90023
Clinical Research Program
Marlton, New Jersey, 08053
McMillen & Magargle
Mechanicsburg, Pennsylvania, 17055
Sunstone Medical Research
Medford, Oregon, 97504
Nautical Clinical Research
Meridian, Idaho, 83642
Kendall South Medical Center, Inc.
Miami, Florida, 33175
Northstar Medical Research, LLC
Middleburg Heights, Ohio, 44130
Virginia Research Center, LLC
Midlothian, Virginia, 23114
Facey Medical Foundation
Mission Hills, California, 91345
Montana Medical Research, Inc.
Missoula, Montana, 59808
Healthscan Research
Montgomery, Alabama, 36109
Gastroenterology Group of Naples
Naples, Florida, 34102
Physicians Regional Medical Group
Naples, Florida, 34119
Better Health Clinical Research
Newnan, Georgia, 30265
Pain Specialists of Charleston
North Charleston, South Carolina, 29406
Ocala Rheumatology Research Center
Ocala, Florida, 34474
Paddock Park Clinical Research
Ocala, Florida, 34474
North County Clinical Research
Oceanside, California, 92056
COR Clinical Research, LLC
Oklahoma City, Oklahoma, 73103
Sooner Clinical Research
Oklahoma City, Oklahoma, 73112
Journey Research, Inc.
Oldsmar, Florida, 34677
SDS Clinical Trials, Inc.
Orange, California, 92868
Compass Research
Orlando, Florida, 32806
Bluegrass Internal Medicine
Owensboro, Kentucky, 42303
Andres Patron, DO, PA
Pembroke Pines, Florida, 30026
Knight Center for Integrated Health
Peoria, Illinois, 61614
Anasazi Internal Medicine PC
Phoenix, Arizona, 85032
Advent Clinical Research Centers
Pinellas Park, Florida, 33781
Gold Coast Research, LLC
Plantation, Florida, 33317
Fanno Creek Clinic
Portland, Oregon, 97219
Health Concepts
Rapid City, South Dakota, 57702
Bobby Huynh
Richardson, Texas, 75080
Probe Clinical Research Corporation
Riverside, California, 92501
U of Rochester
Rochester, New York, 14618
Orthopedic Research Institite
Royal Palm Beach, Florida, 33411
Shores Medical Associates
Saint Clair Shores, Michigan, 48081
Lifetree Clinical Research
Salt Lake City, Utah, 84106
Sun Research Institute
San Antonio, Texas, 78215
IC Research
Sanford, Florida, 32771
Probe Clinical Research Corporation - Santa Ana
Santa Ana, California, 92701
Sarasota Memorial Pain Care Center
Sarasota, Florida, 34238
The Research Institute
Springfield, Massachusetts, 01107
Mid-America Clinical Research LLC
St Louis, Missouri, 63139
Clinical Research Atlanta
Stockbridge, Georgia, 30281
Spring Clinical Research
Sugar Land, Texas, 77478
Pioneer Research Solutions
Sugar Land, Texas, 77479
River Region Research
Tallassee, Alabama, 36078
Tampa Clinical Research
Tampa, Florida, 33624
Omega Medical Research
Warwick, Rhode Island, 02886
ACR Research Salt Lake City
West Jordan, Utah, 84088
Westlake Medical Research
Westlake Village, California, 91361
Coastal Research
Weymouth, Massachusetts, 02190
Pharmacotherpy Research Associates Inc
Zanesville, Ohio, 43701
United Kingdom10 sites
The Waterfront Medical Centre
Barry, Wales, CF63 4AR
Ballygomartin Group Practice
Belfast, Northern Ireland, BT13 3BW
Sea Road Surgery
Bexhill-on-Sea, E.Sussex, TN40 1JJ
Fylde Coast Clinical Research Ltd
Blackpool, Lancsashire, FY3 7EN
Valleyfield Health Center
Dunfermline, KY12 8SJ
ElyBridge Surgery
Ely, Cardiff, CF5 4AE
Frome Medical Practice
Frome, BA11 1EZ
Randalstown Medical Practice
Randalstown, Co Antrim, BT41 3AE
Mortimer Surgery
Reading, RG7 3SG
Sheepcot Medical Centre,
Watford, Herts, WD25 0EA
Czechia7 sites
St. Anne's University Hospital - centrum pro
Brno, 656 91
Nemocnice Jablonec nad Nisou, p.o.
Jablonec nad Nisou, 466 60
Ambulance bolesti, Krajska nemocnice Liberec
Liberec, 460 63
Klaudianova nemocnice Mlada Boleslav
Mladá Boleslav, 293 50
Clintrial s.r.o.
Prague, 108 00
Neurologicka ambulance
Prague, 160 00
Regional Hospital T. B., a.s.
Zlín, 762 75
Belgium3 sites
Huisartsenpraktijk De Regenboog
Antwerp, 2100
Pain Clinic-Heilig Hart Ziekenhuis Roeselare
Roeselare, Westlaan 123, 8800
Dr Capiau - GP Practice
Wetteren, 9230
Germany3 sites
Schmerzzentrum Berlin
Berlin, 10435
Schmerztherapeutische- Ärztezentrum Nordstadt
Hanover, 30167
Schmerz und Palliativzentrum
Wiesbaden, 65189
Sweden3 sites
Hagakliniken
Gothenburg, 13 28
Karolinska University Hospita- Dept of Anaesthesia, Pain Div.
Stockholm, 4186
S3 Clinical Research Centers
Vällingby, Stockholm 162 68
Poland1 site
NZOZ Dom Sue Ryder prowadzony przez Pallmed Sp. z o.o.
Bydgoszcz, 85-796
About this study
Official title: 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.
- Conditions
- Opioid-induced Bowel Dysfunction
- Being tested
- Lubiprostone, Placebo
- Medical subject headings
- Opioid-Induced Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LubiprostoneDrug
Also called Amitiza
24 mcg administered orally twice daily (BID)
PlaceboDrug
Also called No other names
Matching placebo, 0 mcg administered orally twice daily (BID)
| Study group | Role | What they receive |
|---|---|---|
| Lubiprostone | Experimental | 24 mcg capsules twice daily (BID) Receives: Drug: Lubiprostone |
| Placebo | Placebo comparator | 0 mcg capsules twice daily (BID) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Classified as Treatment Responders Within 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.
Measured: 12 weeks
Secondary outcomes (4)
Number of SBMs Per Week at Week 8
Measured: at Week 8
Number of Participants Who Experienced First SBM Within 48 Hours After Dose Initiation
Measured: within 48 hours post-dose
Number of SBMs Per Week at Week 12
Measured: at Week 12
Number of SBMs Per Week Overall
Overall is defined as the length of time from first dose to last follow-up within 2 weeks after last dose.
Measured: within 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2011 (estimated)
- Study startDec 2010
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Opioid-induced Bowel DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 439 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sucampo Pharma Americas, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sucampo Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Clinical Study Leader, Study director, Mallinckrodt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01298219
- Sponsor's protocol ID
- OBD1033
- Status last verified
- Feb 2013
- First submitted
- 20 Jan 2011
- Last updated
- 11 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Placebo-controlled, Double-blinded Study of the Efficacy and Safety of Lubiprostone in Subjects With Opioid-induced Bowel Dysfunction
- ClinicalTrials.gov ID
- NCT01298219
- Acronym / sponsor ID
- OBD1033
- Conditions
- Opioid-induced Bowel Dysfunction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 439 participants (actual)
- Lead sponsor
- Sucampo Pharma Americas, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Sucampo Pharmaceuticals, Inc.
- Study start
- Dec 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 17 Feb 2011 (estimated)
- Results
- Posted 24 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of the study is to evaluate the efficacy and safety of lubiprostone administration in subjects with Opioid-induced Bowel Dysfunction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lubiprostone | Experimental | Drug: Lubiprostone24 mcg capsules twice daily (BID) |
| Placebo | Placebo comparator | Drug: Placebo0 mcg capsules twice daily (BID) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LubiprostoneAlso: Amitiza24 mcg administered orally twice daily (BID) | Drug | Lubiprostone |
| PlaceboAlso: No other namesMatching placebo, 0 mcg administered orally twice daily (BID) | Drug | Placebo |
Primary outcome
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.
4 secondary outcomes
Number of SBMs Per Week at Week 8
Time frame: at Week 8
Number of Participants Who Experienced First SBM Within 48 Hours After Dose Initiation
Time frame: within 48 hours post-dose
Number of SBMs Per Week at Week 12
Time frame: at Week 12
Number of SBMs Per Week Overall
Time frame: within 14 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Study Leader study director
Mallinckrodt
142 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lubiprostone in people with Opioid-induced Bowel Dysfunction, run by Sucampo Pharma Americas, LLC at 142 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 142 sites in United States, United Kingdom, Czechia, Belgium, Germany and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Classified as Treatment Responders Within 12 Weeks (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2020.