A Study of Alvimopan for the Management of Postoperative Ileus in Participants Undergoing Radical Cystectomy

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Status and phase: Completed; Phase 4

Conditions: Postoperative Ileus

Treatments: Drug: Placebo; Drug: Alvimopan

Study type: Interventional

Funder types: Industry

Identifiers

NCT00708201

3753-002

14CL403 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 280 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• are either Male or Female at least 18 years of age
• are scheduled for radical cystectomy
• are scheduled to receive postoperative pain management with intravenous participant-controlled opioid analgesics

Exclusion criteria

• are scheduled for a partial cystectomy
• have taken more than 3 doses of opioids (oral or parenteral) within 7 days before the day of surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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280 participants in 2 patient groups, including a placebo group

Alvimopan

Experimental group

Description:

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

Treatment:

Drug: Alvimopan

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo