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 3
months 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: Since
starting opioid therapy, the subject has had decreased bowel movement (BM) frequency
and at least one of the following constipation symptoms [sensation of incomplete
evacuation, difficulty in expelling stool (straining), hard stools (abnormal stool
consistency)].

- Participant understands the procedures, agrees to participate in the study, and has
signed and dated the informed consent form prior to the initiation of any
study-related activities, including discontinuation of pre-study laxative regimen or
other prohibited medications.

- Participant is able and willing to comply with a daily paper diary and is capable of
completing 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 using
laxatives of all types and formulation at the Screening Visit and throughout the
entire study.

- Participant has severe constipation that has not been appropriately managed such that
the 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 days
prior 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 alkyloids
during the study.

- Participant is currently undergoing abdominal radiation therapy and/or plans to
undergo abdominal radiation therapy during the study.

- Participant is human immunodeficiency virus (HIV)-infected, has active hepatitis (any
subtype including ongoing chronic hepatitis B), or has ever been infected with
hepatitis C.