Opioid-induced Bowel Dysfunction (OBD) Pivotal Assessment of Lubiprostone (OPAL)

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

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

Criteria

Inclusion Criteria:

A patient can be considered for eligibility to participate if he/she:

• Has been consistently treated for chronic, noncancer-related pain with any oral, transdermal, intravenous, or subcutaneous opioid for at least 30 days prior to screening

• Is diagnosed with OBD

• Is capable of utilizing an electronic diary to report daily spontaneous bowel movements (SBMs)

• Is willing to continue opioid therapy and discontinue the use of laxatives, stool softeners, and other concomitant medications affecting gastrointestinal motility throughout the study

Exclusion Criteria:

A patient cannot be considered for eligibility to participate if he/she:

• Uses opioids for the treatment of cancer-related pain, abdominal pain, mechanical bowel obstructions, bowel disorders, and constipation not arising from opioid use, but instead attributable to dietary, neurologic, congenital, or endocrine disorders, scleroderma, and/or for the management of drug addiction