NCT01704651

Accelerating Gastrointestinal Recovery

Accelerating Gastrointestinal Recovery in Women Undergoing Staging and/or Debulking Surgery for Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma: A Randomized, Double-Blind, Placebo-Controlled Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 146 (actual)
• Sponsor: Jamie N. Bakkum-Gamez · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to determine whether an oral perioperative medication (alvimopan--a selective mu antagonist) improves bowel recovery over placebo after surgery for ovarian cancer.

Conditions

• Ovarian Cancer
• Fallopian Tube Cancer
• Peritoneal Cancer

Interventions

Type	Name	Description
DRUG	Alvimopan	Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative.
DRUG	Placebo	Perioperative administration of placebo, at same dosing interval as study drug.

Timeline

• Start date: 2013-01-01
• Primary completion: 2015-08-01
• Completion: 2015-10-01
• First posted: 2012-10-11
• Last updated: 2016-10-24
• Results posted: 2016-10-24

Locations

1 site across 1 country: United States