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Opioid-Induced Bowel DysfunctionPhase 3NCT00620061

Opioid-induced Bowel Dysfunction: Long-Term Assessment of Lubiprostone

A Phase 3 study testing Lubiprostone 24 in people with Opioid-Induced Bowel Dysfunction, run by Sucampo Pharma Americas, LLC at 123 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. 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 24
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
439 participants
Where
123 sitesin 2 countries
Study dates
Dec 2007to Sep 2009
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

  • 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

Who cannot join

  • 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

Trial locations and contacts

123 sites in 2 countries.

123 sites in 2 countries

United States120 sites

  • Lehigh Gastroenterology Associates

    Allentown, Pennsylvania, 18104

  • Advanced Clinical Research Institute

    Anaheim, California, 92801

  • Orange County Clinical Trials

    Anaheim, California, 92801

  • Advanced Pain Institute

    Arcadia, California, 91007

  • Pinnacle Trials Inc.

    Atlanta, Georgia, 30329

  • Northwest Gastroenterology Associates

    Bellevue, Washington, 98004

  • Pain and Rehabilitation Medicine

    Bethesda, Maryland, 20814

  • Impact Clinical Trials

    Beverly Hills, California, 90036

  • The Birmingham Pain Center

    Birmingham, Alabama, 35242

  • Millenium Pain Center

    Bloomington, Illinois, 61701

  • Meridien Research

    Brooksville, Florida, 34601

  • Gastroenterology Research Associates, LLC

    Cedar Knolls, New Jersey, 07927

  • Southeastern Clinical Research

    Chattanooga, Tennessee, 37403

  • Brigham and Women's Hosptial

    Chestnut Hill, Massachusetts, 02467

  • University of Illinois at Chicago: Department of Medicine

    Chicago, Illinois, 60612

  • Apex Medical Research, AMR, Inc

    Chicago, Illinois, 60616

  • New River Valley Research Institute

    Christiansburg, Virginia, 24073

  • Glenway Family Medicine

    Cincinnati, Ohio, 45238

  • Clinicos, LLC

    Colorado Springs, Colorado, 80904

  • Lynn Institute of the Rockies

    Colorado Springs, Colorado, 80907

  • Columbia Medical Practice/ RxTrials, Inc.

    Columbia, Maryland, 21045

  • The Ohio State University Medical Center

    Columbus, Ohio, 43210

  • North Georgia Premier Research

    Dawsonville, Georgia, 30534

  • Hometown Urgent Care and Research

    Dayton, Ohio, 45432

  • Century Clinical Research Inc

    Daytona Beach, Florida, 32117

  • International Medical Research

    Daytona Beach, Florida, 32117

  • Center for Clinical Studies

    Dearborn, Michigan, 48124

  • Best Clinical Research

    Decatur, Georgia, 30034

  • Duke University Medical Center

    Durham, North Carolina, 27705

  • MAPS Applied Research Center

    Edina, Minnesota, 55435

  • Central Jersey Medical Research Center

    Elizabeth, New Jersey, 07202

  • Pain Research of Oregon, LLC

    Eugene, Oregon, 97401

  • MediSphere Medical Research Center, LLC

    Evansville, Indiana, 47714

  • Apex Medical Research, AMR, Inc.

    Flint, Michigan, 48504

  • Clinical Physiology Associates/Clinical Study Center

    Fort Myers, Florida, 33916

  • Southeastern Integrated Medical, PL dba Florida

    Gainesville, Florida, 32607

  • Digestive and Liver Disease Specialists

    Garden Grove, California, 92840

  • RX Clinical Research, Inc.

    Garden Grove, California, 92843

  • Long Island Gastrointestinal Research Group

    Great Neck, New York, 11023

  • Carolina Research

    Greenville, North Carolina, 27834

  • Comprehensive Pain Specialists, PLLC

    Hendersonville, Tennessee, 37075

  • Peters Medical Research, LLC

    High Point, North Carolina, 27262

  • Century Clinical Research

    Holly Hill, Florida, 32117

  • Arkansas Pain Research

    Hot Springs, Arkansas, 71913

  • Simon Williamson Clinic, PC

    Hueytown, Alabama, 35023

  • Texas Familicare Clinical Research

    Hurst, Texas, 76054

  • Davis Clinic, PC

    Indianapolis, Indiana, 46260

  • Professional Clinical Research - Interlochen

    Interlochen, Michigan, 49641

  • Florida Institute of Medical Research

    Jacksonville, Florida, 32257

  • Drug Study Institute

    Jupiter, Florida, 33458

  • Beyer Research

    Kalamazoo, Michigan, 49009

  • Office of Stephen H. Miller, MD

    Las Vegas, Nevada, 89106

  • Affiliated Clinical Research, Inc.

    Las Vegas, Nevada, 89144

  • Ladder Family Practice

    Las Vegas, Nevada, 89146

  • Impact Clinical Trials

    Las Vegas, Nevada, 89206

  • Sunrise Medical Research, Inc.

    Lauderdale Lakes, Florida, 33319

  • The Pain Treatment Center of the Bluegrass

    Lexington, Kentucky, 40503

  • Teton Research, LLC

    Little Rock, Arkansas, 72205

  • Loma Linda University

    Loma Linda, California, 92354

  • DCOL Center for Clinical Research

    Longview, Texas, 75605

  • Virtua Lumberton Family Physicians

    Lumberton, New Jersey, 08048

  • Drug Studies America

    Marietta, Georgia, 30060

  • RAS Health Ltd.

    Marion, Ohio, 43302

  • Medford Medical Clinic, LLP

    Medford, Oregon, 97504

  • Clinical Research Advantage, Inc./ Mesa Family Medical Center

    Mesa, Arizona, 85203

  • Integrity Clinical Research, LLC

    Milan, Tennessee, 38358

  • VAMC Milwaukee

    Milwaukee, Wisconsin, 53295

  • Montana Neuroscience Institute Foundation / Montana Spine and Pain Center

    Missoula, Montana, 59802

  • Alabama Orthopedic Clinic

    Mobile, Alabama, 36608

  • Advanced Diagnostic Pain Treatment Center

    New Haven, Connecticut, 06511

  • NYU Pain Management Center

    New York, New York, 10016

  • Research Across America

    New York, New York, 10022

  • Kenneth W. Ponder, MD, PA

    Niceville, Florida, 32578

  • Digestive and Liver Disease Specialists

    Norfolk, Virginia, 23502

  • Trident Institute of Medical Research, LLC

    North Charleston, South Carolina, 29406

  • North Miami Research Inc.

    North Miami, Florida, 33161

  • Advanced Research Institute

    Ogden, Utah, 84405

  • COR Clinical Research, LLC

    Oklahoma City, Oklahoma, 73103

  • McBride Clinic

    Oklahoma City, Oklahoma, 73112

  • Memorial Clinical Research

    Oklahoma City, Oklahoma, 73134

  • Pasadena Rehabilitation Institute

    Pasadena, California, 91105

  • Redhead Research Inc.

    Peoria, Illinois, 161614

  • Albert Einstein Healthcare Network Einstein Pain Institute

    Philadelphia, Pennsylvania, 19141

  • Redpoint Research

    Phoenix, Arizona, 85029

  • HOPE Research Institute

    Phoenix, Arizona, 85050

  • Clinical Research Advantage, Inc.

    Phoenix, Arizona, 85128

  • DMI Health Care Group, Inc.

    Pinellas Park, Florida, 33782

  • Accord Clinical Research, LLC

    Port Orange, Florida, 32129

  • Affinity Research

    Portland, Oregon, 97219

  • Hampton Roads Institution for Performance and Sports Medicine

    Portsmouth, Virginia, 23707

  • McGuire VA Medical Center

    Richmond, Virginia, 23249

  • University of Rochester, Pain Treatment Center

    Rochester, New York, 14642

  • Northern California Research Corporation

    Sacramento, California, 95831

  • Highland Clinical Research

    Salt Lake City, Utah, 84124

  • Rider Research Group

    San Francisco, California, 94117

  • Louisiana Research Center, LLC

    Shreveport, Louisiana, 71103

  • The Willis-Knighton Interventional Pain Center

    Shreveport, Louisiana, 71105

  • Medex Healthcare Research Inc.

    St Louis, Missouri, 63117

  • Meridien Research

    St. Petersburg, Florida, 33709

  • Clinical Research of West Florida, Inc.

    Tampa, Florida, 33603

  • Stedman Clinical Trials

    Tampa, Florida, 33613

  • Holy Name Hospital

    Teaneck, New Jersey, 07666

  • Clinical Research Advantage, Inc. / East Valley Family Physicians, PLC

    Tempe, Arizona, 85222

  • Clinical Research Advantage, Inc.

    Tempe, Arizona, 85282

  • Premiere Pharamaceutical Research, LLC

    Tempe, Arizona, 85282

  • Medical Research Associates

    Traverse City, Michigan, 49684

  • Center for Digestive Health

    Troy, Michigan, 48098

  • Genova Clinical Research

    Tucson, Arizona, 85704

  • Verona Clinical Research, Inc.

    Tucson, Arizona, 85710

  • Advanced Clinical Therapeutics, LLC

    Tucson, Arizona, 85712

  • Paradigm Clinical Research, Inc.

    Tucson, Arizona, 85712

  • Quality of Life Medical & Research Center, LLC

    Tucson, Arizona, 85712

  • Wilson and Charani

    Tucson, Arizona, 85741

  • MedVadis Research Corporation

    Wellesley Hills, Massachusetts, 02481

  • Intergrated Clinical Trial Services, Inc

    West Des Moines, Iowa, 50265

  • Palm Beach Research Center

    West Palm Beach, Florida, 33409

  • Upstate Clinical Research Associates

    Williamsville, New York, 14221

  • The Center for Clinical Research

    Winston-Salem, North Carolina, 27103

  • Jeffry A. Lindenbaum DO, PC

    Yardley, Pennsylvania, 19067

  • ShahShreenath Clinical Service

    Yorba Linda, California, 92886

Other trials in United States

Canada3 sites

  • AIM Health Group London North

    London, Ontario, N5X 4E7

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1 W8

  • Health Sciences Centre Pain Clinic

    Winnipeg, Manitoba, R3A 1R9

Other trials in Canada

About this study

Official title: 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.

Being tested
Lubiprostone 24
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.

  • Lubiprostone 24Drug

    Also called Amitiza

    24 mcg capsules for oral administration

Study groups in NCT00620061
Study groupRoleWhat they receive
All ParticipantsExperimentalLubiprostone: 24 mcg capsule twice daily (BID) for 36 weeks
Receives: Drug: Lubiprostone 24

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9

  2. Mean Weekly Bowel Movements (BMs) Per Month

    A Bowel Movement (BM) is defined as any BM (whether spontaneous or not)

    Measured: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9

Secondary outcomes (10)

  1. 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.

    Measured: Months 1, 2, 3, 4, 5, 6, 7, 8, and 9

  2. 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.

    Measured: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9

  3. 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.

    Measured: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9

  4. 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.

    Measured: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9

  5. 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.

    Measured: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9

  6. 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.

    Measured: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9

  7. 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.

    Measured: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9

  8. 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.

    Measured: Months 1, 2, 3, 4, 5, 6, 7, 8, and 9

  9. Mean Weekly Complete SBMs by Month

    Participants rate each SBM as complete if their bowels feel completely empty after the SBM

    Measured: Months 1, 2, 3, 4, 5, 6, 7, 8, and 9

  10. Mean Weekly Complete BMs by Month

    Participants rate each BM as complete if their bowels feel completely empty after the BM

    Measured: Months 1, 2, 3, 4, 5, 6, 7, 8, and 9

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2008 (estimated)
  2. Study startDec 2007
  3. Primary completionSep 2009
  4. Study completionSep 2009

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
439 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00620061
Sponsor's protocol ID
OBD06S1
Status last verified
Mar 2018
First submitted
11 Feb 2008
Last updated
21 Jan 2020
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lubiprostone 24 in people with Opioid-Induced Bowel Dysfunction, run by Sucampo Pharma Americas, LLC at 123 sites in 2 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 3 inclusion and 3 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 21 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 123 sites in United States, Canada. 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. 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 30 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?

Mean Weekly Spontaneous Bowel Movements (SBMs) Per Month (time frame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00620061.

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 21 Jan 2020.

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