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Opioid-Induced Bowel DysfunctionPhase 3OPALNCT00597428

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 114 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 (OBD). 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
437 participants
Where
114 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 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 inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), or monoamine oxidase (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

  • Opioid dose adjustment (+/- 30%), and/or change in opioid agent or route of administration within 30 days of screening.
  • Non-ambulatory patients, or those who are unable to eat/drink, take oral medications, or to hold down oral medications due to vomiting.
  • 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).
  • Gastrointestinal or abdominal surgical procedures within 90 days prior to screening.
  • 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.

Trial locations and contacts

114 sites in 2 countries.

114 sites in 2 countries

United States109 sites

  • Lehigh Valley Hospital - Neurosciences and Pain Research

    Allentown, Pennsylvania, 18103

  • Advanced Pain Institute

    Arcadia, California, 91007

  • Randolph Medical Associates

    Asheboro, North Carolina, 27203

  • Advanced Pain Management

    Augusta, Georgia, 30901

  • Pain Institute of CA

    Bakersfield, California, 93311

  • Rehabilitation Team West, PA

    Baltimore, Maryland, 21228

  • Northwest Gastroenterology Associates

    Bellevue, Washington, 98004

  • Clinical Trial Management of Boca Raton, Inc.

    Boca Raton, Florida, 33486

  • Beth Israel Deaconess Medical Center, Harvard Medical School

    Boston, Massachusetts, 02215

  • Global Research Partners & Consultants, Incs.

    Calhoun, Georgia, 30701

  • Gastroenterology Research Associates

    Cedar Knolls, New Jersey, 07927

  • Valley Medical Primary Care

    Centerville, Ohio, 45459

  • Clinical Research Institute of Michigan, LLC

    Chesterfield, Michigan, 48047

  • Apex Medical Research, AMR, Inc.

    Chicago, Illinois, 60616

  • Claude Mandel Medical Center

    Chicago, Illinois, 60617

  • Catalina Research Institute, LLC

    Chino, California, 91710

  • New River Valley Research Institute

    Christiansburg, Virginia, 24073

  • Glenway Family Medicine

    Cincinnati, Ohio, 45238

  • Clinicos, LLC

    Colorado Springs, Colorado, 80904

  • Columbia Medical Practice/ RxTrials, Inc.

    Columbia, Maryland, 21045

  • The Ohio State University Medical Center

    Columbus, Ohio, 43210-1228

  • Urgent Care Specialists

    Dayton, Ohio, 45432

  • Q Clinical Research

    Decatur, Georgia, 30035

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • MAPS Applied Research Center

    Edina, Minnesota, 55435

  • Central Jersey Medical Research Center

    Elizabeth, New Jersey, 07202

  • Advanced Pain Care Clinic

    Evansville, Indiana, 47630

  • MediSphere Medical Research Center

    Evansville, Indiana, 47714

  • Precise Research, Inc.

    Flowood, Mississippi, 39232

  • Carolina Research

    Greenville, North Carolina, 27834

  • Washington County Hospital Association - The Center for Clinical Research

    Hagerstown, Maryland, 21742

  • Carolina Digestive Health Associates

    Harrisburg, North Carolina, 28075

  • Peters Medical Research, LLC

    High Point, North Carolina, 27262

  • California Pain Center

    Huntington Beach, California, 92647

  • Texas Familicare Clinical Research

    Hurst, Texas, 76054

  • Davis Clinic, PC

    Indianapolis, Indiana, 46260

  • Professional Clinical Research, Inc.

    Interlochen, Michigan, 49643

  • Florida Institute of Medical Research

    Jacksonville, Florida, 32257

  • Drug Study Institute

    Jupiter, Florida, 33458

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Baptist Medical Tower Suite 740

    Knoxville, Tennessee, 37920

  • Gulf Coast Research, LLC

    Lafayette, Louisiana, 70503

  • Shreenath Clinical Service

    Laguna Hills, California, 92637

  • Rocky Mountain Gastroenterology Associates

    Lakewood, Colorado, 80215

  • PCM Medical Services

    Lansing, Michigan, 48917

  • Advanced Biomedical Research of America

    Las Vegas, Nevada, 89123

  • Lovelace Scientific Resources, Inc.

    Las Vegas, Nevada, 89146

  • Triangle Medical Research

    Lexington, North Carolina, 27295

  • Martin Bowen Hefley Knee

    Little Rock, Arkansas, 72205

  • Arapahoe Gastroenterology, PC

    Littleton, Colorado, 80120

  • Metro Clinical Research, LLC

    Littleton, Colorado, 80122

  • Loma Linda University Physicians Medical Group

    Loma Linda, California, 92354

  • VA Long Beach Healthcare System

    Long Beach, California, 90822-5201

  • DCOL Center for Clinical Research

    Longview, Texas, 75605

  • University of Louisville

    Louisville, Kentucky, 40202

  • RAS Health Ltd.

    Marion, Ohio, 43302

  • Medford Medical Clinic, LLP

    Medford, Oregon, 97504

  • Integrity Clinical Research, LLC

    Milan, Tennessee, 38358

  • Montana Neuroscience Institute Foundation / Montana Spine and Pain Center

    Missoula, Montana, 59802

  • Delta Research Partners, LLC

    Monroe, Louisiana, 71201

  • Gastroenterology Group of Naples

    Naples, Florida, 34102

  • Southern Gastroenterology Associates

    New Bern, North Carolina, 28562

  • Medex Healthcare Research, Inc.

    New York, New York, 10004

  • New York University Pain Management Center

    New York, New York, 10016

  • Research Across America

    New York, New York, 10022

  • Kenneth W. Ponder, MD PA

    Niceville, Florida, 32578

  • North Miami Research, Inc.

    North Miami, Florida, 33161

  • Renstar Inc.

    Ocala, Florida, 34471

  • Advance Research Institute

    Ogden, Utah, 84405

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112

  • Paradigm Research Professionals, LLP

    Oklahoma City, Oklahoma, 73112

  • Memorial Clinical Research

    Oklahoma City, Oklahoma, 73134

  • Creighton University Medical Center

    Omaha, Nebraska, 68131

  • Peninsula Research, Inc

    Ormond Beach, Florida, 32174

  • Women's Health Care Specialists, PC

    Paw Paw, Michigan, 49079

  • Einstein Pain Institute

    Philadelphia, Pennsylvania, 19414

  • Carl T Hayden VA Medical Center

    Phoenix, Arizona, 85012

  • Redpoint Research

    Phoenix, Arizona, 85029

  • HOPE Research Institute, LLC

    Phoenix, Arizona, 85050

  • DMI Research, Inc.

    Pinellas Park, Florida, 33782

  • Sunrise Medical Research, Inc.

    Plantation, Florida, 33324

  • Accord Clinical Research, LLC

    Port Orange, Florida, 32129

  • Hampton Roads Institute for Performance and Sports Medicine (HIPS)

    Portsmouth, Virginia, 23707

  • Bexar Clinical Trials, LLC

    Richardson, Texas, 75082

  • McGuire Research Institute

    Richmond, Virginia, 23249

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Highland Clinical Research

    Salt Lake City, Utah, 84124

  • University of Utah

    Salt Lake City, Utah, 84132-2410

  • Rider Research Group

    San Francisco, California, 94117

  • Lovelace Scientific Resources, Inc.

    Sarasota, Florida, 34233

  • Louisiana Research Center, LLC

    Shreveport, Louisiana, 71103

  • Daniel R. Coulston

    Spokane, Washington, 99204

  • Medex Healthcare Research

    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, Institute for Clinical Research

    Teaneck, New Jersey, 07666

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

    Tempe, Arizona, 85222

  • Premiere Pharamaceutical Research, LLC

    Tempe, Arizona, 85282

  • University of Toledo - Health Science Campus

    Toledo, Ohio, 43614

  • Medical Research Associates

    Traverse City, Michigan, 49684

  • Center for Digestive Health

    Troy, Michigan, 48098

  • Harmony Clinical Research, Inc.

    Tucson, Arizona, 85705

  • Tuscaloosa VA Medical Center

    Tuscaloosa, Alabama, 35404

  • North American Partners

    Valley Stream, New York, 11580

  • Advanced Pain Consultants

    Voorhees Township, New Jersey, 08043

  • MedVadis Research Corporation

    Wellesley Hills, Massachusetts, 02481

  • Upstate Clinical Research Associates

    Williamsville, New York, 14221

  • Jeffry A. Lindenbaum DO, PC

    Yardley, Pennsylvania, 19067

Other trials in United States

Canada5 sites

  • Hermitage Medicentre

    Edmonton, Alberta, T5A 4L8

  • St. Joseph's Healthcare Hamilton

    Hamilton, Ontario, L8N 4A6

  • Pharmaceutical Integrated Research Company

    London, Ontario, N5X4E7

  • DHC Research

    Richmond Hill, Ontario, L4B 3P8

  • Health Sciences Centre

    Winnipeg, Manitoba, R3A 1R9

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 (OBD).

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 NCT00597428
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. Change From Baseline in Mean Weekly Spontaneous Bowel Movement (SBM) Frequency in Subjects Without Dose Reduction Prior to Week 8

    Measured: Baseline and Week 8

Secondary outcomes (5)

  1. Change From Baseline in Mean Weekly SBM Frequency

    For overall assessment of change, average weekly rating was calculated from data collected from Week 1 through Week 12.

    Measured: Baseline, Week 12, and Weeks 1-12

  2. First Post-dose SBM

    The number of participants that experienced first post-dose SBM 24 and 48 hour of dose initiation.

    Measured: 24 and 48 hours post-dose

  3. Responder Rate

    Number of participants, who remained on treatment for at least 8 weeks, and reported response (>=3 SBMs) for at least 50% of weeks on study.

    Measured: Up to 12 weeks

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

    Ratings over 12-week treatment period were averaged and difference from baseline score calculated Straining scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe Stool consistency scale: 0 = very loose, 1 = loose, 2 = normal, 3 = hard, 4 = very hard (little balls) Constipation severity scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe Abdominal bloating scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe Abdominal discomfort scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe Bowel habit regularity scale: 7-point scale, where 1 = very regular and 7 = very irregular

    Measured: Weeks 1-12

  5. Treatment Effectiveness

    Treatment effectiveness scale: 0 = not at all effective, 1 = a little bit effective, 2 = moderately effective, 3 = quite a bit effective, 4 = extremely effective

    Measured: Weeks 1-12

Timeline

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

  1. First posted18 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
437 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00597428
Sponsor's protocol ID
OBD0632
Acronym
OPAL
Status last verified
Nov 2015
First submitted
9 Jan 2008
Last updated
10 Dec 2019
Data monitoring committee
No

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 114 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 6 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 10 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 114 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 7 Dec 2015). 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?

Change From Baseline in Mean Weekly Spontaneous Bowel Movement (SBM) Frequency in Subjects Without Dose Reduction Prior to Week 8 (time frame: Baseline and 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 NCT00597428.

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 10 Dec 2019.

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