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 (OBD).

Key facts

Study ID

NCT00597428

Run by

Sucampo Pharma Americas, LLC

People needed

437

Starts

2007-08-01

Expected to finish

2009-03-01

Last updated by the study team

2019-12-10

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 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.

You may not qualify if…

• 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.

Where it is running

• Carl T Hayden VA Medical Center — Phoenix, Arizona, United States
• Redpoint Research — Phoenix, Arizona, United States
• HOPE Research Institute, LLC — Phoenix, Arizona, United States
• Clinical Research Advantage, Inc. / East Valley Family Physicians, PLC — Tempe, Arizona, United States
• Premiere Pharamaceutical Research, LLC — Tempe, Arizona, United States
• Harmony Clinical Research, Inc. — Tucson, Arizona, United States
• Martin Bowen Hefley Knee — Little Rock, Arkansas, United States
• Advanced Pain Institute — Arcadia, California, United States
• Pain Institute of CA — Bakersfield, California, United States
• Catalina Research Institute, LLC — Chino, California, United States
• California Pain Center — Huntington Beach, California, United States
• Shreenath Clinical Service — Laguna Hills, California, United States
• Loma Linda University Physicians Medical Group — Loma Linda, California, United States
• VA Long Beach Healthcare System — Long Beach, California, United States
• Rider Research Group — San Francisco, California, United States
• Clinicos, LLC — Colorado Springs, Colorado, United States
• Rocky Mountain Gastroenterology Associates — Lakewood, Colorado, United States
• Arapahoe Gastroenterology, PC — Littleton, Colorado, United States
• Metro Clinical Research, LLC — Littleton, Colorado, United States
• Clinical Trial Management of Boca Raton, Inc. — Boca Raton, Florida, United States
• Florida Institute of Medical Research — Jacksonville, Florida, United States
• Drug Study Institute — Jupiter, Florida, United States
• Gastroenterology Group of Naples — Naples, Florida, United States
• Kenneth W. Ponder, MD PA — Niceville, Florida, United States
• Tuscaloosa VA Medical Center — Tuscaloosa, Alabama, United States

Full record on ClinicalTrials.gov

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