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

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 toscreening

• Is diagnosed with OBD

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

• Is willing to continue opioid therapy and discontinue the use of laxatives, stoolsofteners, and other concomitant medications affecting gastrointestinal motilitythroughout 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, mechanicalbowel obstructions, bowel disorders, and constipation not arising from opioid use, butinstead attributable to dietary, neurologic, congenital, or endocrine disorders,scleroderma, and/or for the management of drug addiction