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

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sucampo Pharma Americas, LLC; Sucampo Pharmaceuticals, Inc.
• Collaborator: Takeda
• Treatments: Lubiprostone

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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