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Opioid-Induced Bowel DysfunctionPhase 3OPALNCT00595946

Opioid-induced Bowel Dysfunction: Pivotal Assessment of Lubiprostone

A Phase 3 study testing Lubiprostone in people with Opioid-Induced Bowel Dysfunction, run by Sucampo Pharma Americas, LLC at 95 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 primary purpose of this study is to evaluate the efficacy and safety of lubiprostone administration in patients 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
95 sitesin 2 countries
Study dates
Aug 2007to Mar 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

  • Consistent treatment for chronic, non-cancer-related pain with any full agonist opioid for at least 30 days prior to screening.
  • Diagnosis of opioid-induced bowel dysfunction (OBD) as confirmed during the screening period.
  • If patient has a history of chronic constipation, condition must have been exacerbated by initiation of opioid treatment.
  • Use of prescribed or Over-the-Counter (OTC) medication that affects gastrointestinal motility (other than opioid therapy) must be discontinued during the study.
  • If treated for clinical depression with Selective serotonin reuptake inhibitor (SSRIs), Serotonin-norepinephrine reuptake inhibitor (SNRIs), or Monoamine oxidase inhibitor (MAO) inhibitors, treatment must have been at a stable dose for at least 30 days prior to screening.
  • Use of laxative and stool softeners (with the exception of approved rescue medications) must be discontinued while on study.

Who cannot join

  • Treatment with opioid therapy for cancer-related pain, abdominal pain, scleroderma, and/or for the management of drug addiction.
  • Patient has been treated for cancer in the past 5 years (with the exception of localized basal cell, squamous cell skin cancer, or in situ cancer that has been resected).
  • Opioid dose adjustment (+/- 30%), and/or change in opioid agent or route of administration within 30 days of screening.
  • Gastrointestinal or abdominal surgical procedures within 90 days prior to screening.
  • Non-ambulatory patients, or those who are unable to eat/drink, take oral medications, or to hold down oral medications due to vomiting.
  • Female patients of childbearing potential who are unable/unwilling to use protocol-specified method(s) of birth control and/or are pregnant, nursing, or plan to become pregnant or nurse during the study.
  • Prior use of Amitiza, lubiprostone, SPI-0211, or RU-0211.

Trial locations and contacts

95 sites in 2 countries.

95 sites in 2 countries

United States94 sites

  • Private Practice of Dr. Hasan

    Allentown, Pennsylvania, 18104

  • Advanced Clinical Research Institute

    Anaheim, California, 92801

  • Orange County Clinical Trials, Inc.

    Anaheim, California, 92801

  • Gulf Coast Research, LLC

    Baton Rouge, Louisiana, 70808

  • Professional Clinical Research, Benzonia

    Benzonia, Michigan, 49616

  • Pain and Rehabilitation Medicine

    Bethesda, Maryland, 20814

  • The Birmingham Pain Center

    Birmingham, Alabama, 35242

  • St. Alexius Medical Center

    Bismarck, North Dakota, 58501

  • Millenium Pain Center

    Bloomington, Illinois, 61701

  • The Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Meridien Research

    Brooksville, Florida, 34613

  • Cooper Health System

    Camden, New Jersey, 08103

  • Southeastern Clinical Research

    Chattanooga, Tennessee, 37403

  • University of Illinois Medical Center

    Chicago, Illinois, 60612

  • Gregory J. Wiener, MD PC

    Chula Vista, California, 91910

  • South Lake Pain Institute

    Clermont, Florida, 34711

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Lynn Institute of the Rockies

    Colorado Springs, Colorado, 80909

  • Partners in Clinical Research

    Cumberland, Rhode Island, 02864

  • Dallas VA Research Corporation, Inc.

    Dallas, Texas, 75216

  • Bexar Clinical Trials, LLC

    Dallas, Texas, 75234

  • North Georgia Premier Research

    Dawsonville, Georgia, 30534

  • Century Clinical Research

    Daytona Beach, Florida, 32117

  • International Medical Research

    Daytona Beach, Florida, 32117

  • Center for Clinical Studies

    Dearborn, Michigan, 48124

  • Best Clinical Research

    Decatur, Georgia, 30034

  • Diversified Research

    Durham, North Carolina, 27704

  • Pain Research of Oregon, LLC

    Eugene, Oregon, 97401

  • Apex Medical Research, AMR, Inc.

    Flint, Michigan, 48504

  • Clinical Physiology Associates/Clinical Study Center

    Fort Myers, Florida, 33916

  • Northway Medical Associates

    Fulton, New York, 13069

  • Southeaster Integrated Medical, PL d/b/a Florida Medical Research Institute

    Gainesville, Florida, 32607

  • Digestive and Liver Disease Specialists

    Garden Grove, California, 92840

  • RX Clinical Research, Inc

    Garden Grove, California, 92843

  • Long Island Clinical Research Associates, LLP

    Great Neck, New York, 11021

  • Long Island Gastrointestinal Research Group

    Great Neck, New York, 11023

  • Medoff Medical/ Vital re:Search

    Greensboro, North Carolina, 27408

  • Comprehensive Pain Specialists, PLLC

    Hendersonville, Tennessee, 37075

  • Simon Williamson Clinic, PC

    Hueytown, Alabama, 35023

  • Rosemark Women Care Specialists

    Idaho Falls, Idaho, 83404

  • Physicians Clinical Research Corporation

    Laguna Hills, California, 92653

  • Impact Clinical Trials, Las Vegas

    Las Vegas, Nevada, 89106

  • Office of Stephen H. Miller, MD

    Las Vegas, Nevada, 89106

  • The Pain Treatment Center of the Bluegrass and Ballard Wright, MD PSC

    Lexington, Kentucky, 40503

  • Loma Linda University Physicians Medical Group

    Loma Linda, California, 92354

  • HealthCare Partners Medical Group

    Long Beach, California, 90807

  • Impact Clinical Trials

    Los Angeles, California, 90036

  • The Regents of the University of California, Los Angeles

    Los Angeles, California, 90095

  • Drug Studies America

    Marietta, Georgia, 30060

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

    Mesa, Arizona, 85203

  • Metro Physicians a Division of Wheaton Franciscan Medical Group

    Milwaukee, Wisconsin, 53221

  • Clement J. Zablocki VA Medical Center

    Milwaukee, Wisconsin, 53295

  • Alabama Orthopedic Clinic

    Mobile, Alabama, 36608

  • Saltzer Medical Group

    Nampa, Idaho, 83686

  • Vanderbilt University - Interventional Pain Center

    Nashville, Tennessee, 37232

  • Advanced Diagnostic Pain Treatment Center

    New Haven, Connecticut, 06511

  • Tulane University Health Sciences Center

    New Orleans, Louisiana, 70112

  • Digestive and Liver Disease Specialists

    Norfolk, Virginia, 23502

  • Trident Institute of Medical Research, LLC

    North Charleston, South Carolina, 29406

  • Permian Research Foundation

    Odessa, Texas, 79761

  • COR Clinical Research, LLC

    Oklahoma City, Oklahoma, 73103

  • Pasadena Rehabilitation Institute

    Pasadena, California, 91105

  • Redhead Research Inc., dba Research Associates of Central Illinois

    Peoria, Illinois, 61614

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • Affinity Research

    Portland, Oregon, 97219

  • University Gastroenterology

    Providence, Rhode Island, 02905

  • Lynn Institute of Pueblo

    Pueblo, Colorado, 81001

  • University of Nevada

    Reno, Nevada, 89557

  • Bexar Clinical Trials, LLC

    Richardson, Texas, 75082

  • General Clinical Research Center, Virginia Commonwealth University, North Hospital

    Richmond, Virginia, 23298

  • International Research Clinicians of Conneticut

    Ridgefield, Connecticut, 06877

  • University of Rochester

    Rochester, New York, 14642

  • Northern California Research Corporation

    Sacramento, California, 95831

  • Salt Lake Research, PLLC

    Salt Lake City, Utah, 84107

  • Integrity Clinical Research, LLC

    Savannah, Tennessee, 38372

  • The Willis-Knighton Pain Management Center

    Shreveport, Louisiana, 71103

  • SB Family Medicine

    Solana Beach, California, 92075

  • Carolina Pharmaceutical Research

    Statesville, North Carolina, 28625

  • Pinnacle Trials Inc.

    Stockbridge, Georgia, 30281

  • UMDNJ

    Stratford, New Jersey, 08084

  • Clinical Research Advantage, Inc.

    Tempe, Arizona, 85282

  • New England Research Associates, LLC

    Trumbull, Connecticut, 06611

  • Harmony Clinical Research, Inc.

    Tucson, Arizona, 85705

  • Verona Clinical Research, Inc.

    Tucson, Arizona, 85710-3539

  • Quality of Life Medical & Research Center, LLC

    Tucson, Arizona, 85712

  • Genova Clinical Research, Inc.

    Tucson, Arizona, 85741

  • Pusch Ridge Family Medicine / WC Clinical Research

    Tucson, Arizona, 85741

  • Digestive Health Specialists, PA

    Tupelo, Mississippi, 38801

  • Preferred Primary Care Physicians

    Uniontown, Pennsylvania, 15401

  • Partners in Primary Care

    Voorhees Township, New Jersey, 08043

  • Abraham D. Morganoff, MD PA

    Watchung, New Jersey, 07069

  • Integrated Clinical Trial Services, Inc.

    West Des Moines, Iowa, 50265

  • Palm Beach Research Center

    West Palm Beach, Florida, 33409

  • Center for Clinical Research, LLC

    Winston-Salem, North Carolina, 27103

Other trials in United States

Canada1 site

  • Health Sciences Center

    Hamilton, Ontario, L8N 3Z5

Other trials in Canada

About this study

Official title: A Multi-center, Randomized, Double-Blinded Study of the Efficacy and Safety of Lubiprostone in Patients With Opioid-induced Bowel Dysfunction (OBD)

The primary purpose of this study is to evaluate the efficacy and safety of lubiprostone administration in patients with 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 capsules twice daily (BID)

  • PlaceboDrug

    Also called No other names

    0 mcg capsules twice daily (BID)

Study groups in NCT00595946
Study groupRoleWhat they receive
PlaceboPlacebo comparator0 mcg capsules twice daily (BID)
Receives: Drug: Placebo
LubiprostoneExperimental24 mcg capsules twice daily (BID)
Receives: Drug: Lubiprostone

What is being measured

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

  1. Mean Weekly Spontaneous Bowel Movements at Week 8

    Spontaneous bowel movements (SBMs) are defined as bowel movements without the aid of drugs.

    Measured: at Week 8

Secondary outcomes (5)

  1. Mean Number of Spontaneous Bowel Movements (SBM) Per Week Within 12 Weeks

    Average weekly SBM frequency was calculated from data collected from Week 1 through Week 12

    Measured: within 12 weeks

  2. Number of Participants With the First Post-dose Spontaneous Bowel Movement Within 48 Hours Post-dose

    The number of participants who experienced their first post-dose Spontaneous Bowel Movement within 24 and 48 hours after dosing started.

    Measured: within 48 hours post-dose

  3. Number of Participants Classified as Responders

    Number of participants who remained on treatment for at least 8 weeks, and reported at least 3 SBMs for at least half the weeks on study.

    Measured: within 12 weeks

  4. Mean Change From Baseline in Straining, Stool Consistency, Constipation Severity, Abdominal Bloating, Abdominal Discomfort, and Bowel Habit Regularity

    Measures collected over 12-week treatment period were averaged, and the score at baseline was subtracted from the score at week 12 to determine the change from baseline.

    Straining scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe - higher scores are worse;

    Stool consistency scale: 0 = very loose, 1 = loose, 2 = normal, 3 = hard, 4 = very hard (little balls) - middle scores are best;

    Constipation severity scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe - higher scores are worse;

    Abdominal bloating scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe - higher scores are worse;

    Abdominal discomfort scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe - higher scores are worse;

    Bowel habit regularity scale: 7-point scale, where 1 = very regular and 7 = very irregular - higher scores are worse

    Measured: within 12 weeks

  5. Participant Reported Outcome of Treatment Effectiveness

    Participants rated treatment effectiveness at the end of each treatment week during the study on a 5-point scale, where 0 = not at all effective, 1 = a little bit effective, 2 = moderately effective, 3 = quite a bit effective, 4 = extremely effective. The 12 weekly scores were averaged. Higher scores mean the drug was more effective.

    Measured: within 12 weeks

Timeline

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

  1. First posted16 Jan 2008 (estimated)
  2. Study startAug 2007
  3. Primary completionMar 2009
  4. Study completionMar 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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
439 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00595946
Sponsor's protocol ID
OBD0631
Acronym
OPAL
Status last verified
Dec 2015
First submitted
4 Jan 2008
Last updated
16 Dec 2019
Data monitoring committee
No
Individual data sharing
No

Publications

  • Cryer B, Katz S, Vallejo R, Popescu A, Ueno R. A randomized study of lubiprostone for opioid-induced constipation in patients with chronic noncancer pain. Pain Med. 2014 Nov;15(11):1825-34. doi: 10.1111/pme.12437. Epub 2014 Apr 9.

    PubMed 24716835

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 95 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 6 inclusion and 7 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 16 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 95 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. 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 3 Feb 2016). 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 at Week 8 (time frame: at Week 8). 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 NCT00595946, which also lists 1 linked publication.

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 16 Dec 2019.

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