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

Completed · Phase 3

Conditions studied: Opioid-Induced Bowel Dysfunction

In brief

The purpose of this study is to evaluate the long-term safety and efficacy of lubiprostone administration in participants with opioid-induced bowel dysfunction.

Key facts

Study ID

NCT00620061

Run by

Sucampo Pharma Americas, LLC

People needed

439

Starts

2007-12-01

Expected to finish

2009-09-01

Last updated by the study team

2020-01-21

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

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
• Redpoint Research — Phoenix, Arizona, United States
• HOPE Research Institute — Phoenix, Arizona, United States
• Clinical Research Advantage, Inc. — Phoenix, Arizona, United States
• Clinical Research Advantage, Inc. / East Valley Family Physicians, PLC — Tempe, Arizona, United States
• Clinical Research Advantage, Inc. — Tempe, Arizona, United States
• Premiere Pharamaceutical Research, LLC — Tempe, Arizona, United States
• Genova Clinical Research — Tucson, Arizona, United States
• Verona Clinical Research, Inc. — Tucson, Arizona, United States
• Advanced Clinical Therapeutics, LLC — Tucson, Arizona, United States
• Paradigm Clinical Research, Inc. — Tucson, Arizona, United States
• Quality of Life Medical & Research Center, LLC — Tucson, Arizona, United States
• Wilson and Charani — Tucson, Arizona, United States
• Arkansas Pain Research — Hot Springs, Arkansas, United States
• Teton Research, LLC — Little Rock, Arkansas, United States
• Advanced Clinical Research Institute — Anaheim, California, United States
• Orange County Clinical Trials — Anaheim, California, United States
• Advanced Pain Institute — Arcadia, California, United States
• Impact Clinical Trials — Beverly Hills, California, United States
• Digestive and Liver Disease Specialists — Garden Grove, California, United States
• RX Clinical Research, Inc. — Garden Grove, California, United States
• Loma Linda University — Loma Linda, California, United States
• The Birmingham Pain Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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