Conditions: Postoperative Ileus
Keywords: ileus POI
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 280
Healthy volunteers: no

Brief summary:
This study is being conducted to determine whether alvimopan can accelerate recovery of gastrointestinal function following radical cystectomy when compared with a placebo. Secondary objectives of the study are:

* to evaluate the effect of alvimopan on hospital length of stay
* to evaluate the effect of alvimopan on prespecified postoperative ileus (POI)-related morbidities
* to evaluate the overall and cardiovascular safety of alvimopan

Detailed description:

Arms:
arm 1: 12 milligrams (mg)

Alvimopan, 12mg, capsule. Administered orally. One 30 minutes to 5 hours before the scheduled start of surgery on Day 0, and twice daily beginning on Postoperative Day 1 (POD 1) until hospital discharge or for a maximum of 7 days (up to 15 doses) of postoperative treatment arm 2: 300 mg polyethylene glycol in a capsule

Administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.

Interventions: intervention 1: Alvimopan intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: