Study Of Alvimopan Drug For Treatment Of Constipation Due To Prescription Pain Medication

Inclusion criteria:

• Participant is in any stage of cancer but has a minimum life expectancy of at least 3months at the time of the Screening Visit.

• Participant is taking opioid therapy for persistent cancer pain.

• Participant meets the definition of opioid-induced bowel dysfunction as follows: Sincestarting opioid therapy, the subject has had decreased bowel movement (BM) frequencyand at least one of the following constipation symptoms [sensation of incompleteevacuation, difficulty in expelling stool (straining), hard stools (abnormal stoolconsistency)].

• Participant understands the procedures, agrees to participate in the study, and hassigned and dated the informed consent form prior to the initiation of anystudy-related activities, including discontinuation of pre-study laxative regimen orother prohibited medications.

• Participant is able and willing to comply with a daily paper diary and is capable ofcompleting paper questionnaires at study visits.

Exclusion criteria:

• Participant is pregnant or lactating, or planning to become pregnant.

• Participant is not ambulatory.

• Participant has participated in another trial with an investigational drug (unapproved), device or procedure within 30 days of the Screening Visit.

• Participant is unable to eat, drink, take/hold down oral medications.

• Participant is taking opioids for the management of drug addiction.

• Participant is unable or unwilling to discontinue the use of and/or refrain from usinglaxatives of all types and formulation at the Screening Visit and throughout theentire study.

• Participant has severe constipation that has not been appropriately managed such thatthe subject is at immediate risk of developing serious complications of constipation.This would include a subject who has reported no bowel movement for 7 consecutive daysprior to the Screening Visit.

• Participant with gastrointestinal or pelvic disorders known to affect bowel transit,produce gastrointestinal (GI) obstruction, or contribute to bowel dysfunction.

• Participant is currently taking vinca alkyloids or plans to take vinca alkyloidsduring the study.

• Participant is currently undergoing abdominal radiation therapy and/or plans toundergo abdominal radiation therapy during the study.

• Participant is human immunodeficiency virus (HIV)-infected, has active hepatitis (anysubtype including ongoing chronic hepatitis B), or has ever been infected withhepatitis C.