A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase IIb Study to Evaluate the Efficacy and Safety of Multiple Alvimopan Dosage Regimens for the Treatment of Opioid-Induced Bowel Dysfunction in Cancer Pain Subjects

Inclusion Criteria

Inclusion criteria:

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

- Subject is taking opioid therapy for persistent cancer pain.

- Subject meets the definition of opioid-induced bowel dysfunction as follows: Since
starting opioid therapy, the subject has had decreased 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)].

- Subject 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.

- Subject is able and willing to comply with a daily paper diary and is capable of
completing paper questionnaires at study visits.

Exclusion criteria:

- Subject is pregnant or lactating, or planning to become pregnant.

- Subject is not ambulatory.

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

- Subject is unable to eat, drink, take/hold down oral medications.

- Subject is taking opioids for the management of drug addiction.

- Subject 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.

- Subject 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.

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

- Subject is currently taking vinca alkyloids or plans to take vinca alkyloids during
the study.

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

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