Opioid-induced Bowel Dysfunction: Pivotal Assessment of Lubiprostone

Completed · Phase 3 · Has a placebo group

Conditions studied: Opioid-Induced Bowel Dysfunction

In brief

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

Key facts

Study ID

NCT00595946

Run by

Sucampo Pharma Americas, LLC

People needed

439

Starts

2007-08-01

Expected to finish

2009-03-01

Last updated by the study team

2019-12-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Simon Williamson Clinic, PC — Hueytown, Alabama, United States
• Alabama Orthopedic Clinic — Mobile, Alabama, United States
• Clinical Research Advantage, Inc./ Mesa Family Medical Center — Mesa, Arizona, United States
• Clinical Research Advantage, Inc. — Tempe, Arizona, United States
• Harmony Clinical Research, Inc. — Tucson, Arizona, United States
• Verona Clinical Research, Inc. — Tucson, Arizona, United States
• Quality of Life Medical & Research Center, LLC — Tucson, Arizona, United States
• Genova Clinical Research, Inc. — Tucson, Arizona, United States
• Pusch Ridge Family Medicine / WC Clinical Research — Tucson, Arizona, United States
• Advanced Clinical Research Institute — Anaheim, California, United States
• Orange County Clinical Trials, Inc. — Anaheim, California, United States
• Gregory J. Wiener, MD PC — Chula Vista, California, United States
• Digestive and Liver Disease Specialists — Garden Grove, California, United States
• RX Clinical Research, Inc — Garden Grove, California, United States
• Physicians Clinical Research Corporation — Laguna Hills, California, United States
• Loma Linda University Physicians Medical Group — Loma Linda, California, United States
• HealthCare Partners Medical Group — Long Beach, California, United States
• Impact Clinical Trials — Los Angeles, California, United States
• The Regents of the University of California, Los Angeles — Los Angeles, California, United States
• Pasadena Rehabilitation Institute — Pasadena, California, United States
• Northern California Research Corporation — Sacramento, California, United States
• SB Family Medicine — Solana Beach, California, United States
• Lynn Institute of the Rockies — Colorado Springs, Colorado, United States
• Lynn Institute of Pueblo — Pueblo, Colorado, United States
• The Birmingham Pain Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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