NCT03352414

Phase 2 RCT of Alvimopan vs. Placebo After CRS/HIPEC

The ILEUS Study: A Phase 2 Randomized Controlled Trial Investigating Alvimopan for Enhanced Gastrointestinal Recovery After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the ability of alvimopan to reduce the time to return of bowel function in patients undergoing cytoreductive surgery and hyperthermic intraperitoneal chemotherapy. Half of the participants will receive alvimopan or and half will receive placebo immediately before and for up to seven days after surgery.

Detailed description

Cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) is a surgical procedure to treat cancer that has spread to the lining of the abdominal cavity (peritoneal metastases). It is associated with a prolonged time for return of bowel function after surgery. Alvimopan is a drug used to speed up the time for return of bowel function after surgery. It works by blocking the opioid receptors in the gastrointestinal tract, which normally slow down bowel function in patients receiving postoperative opioid pain medication. It has not previously been tested in patients undergoing CRS/HIPEC.

Conditions

• Ileus

Interventions

Type	Name	Description
DRUG	Alvimopan	alvimopan pill
DRUG	Placebo	placebo pill

Timeline

• Start date: 2018-03-08
• Primary completion: 2020-04-28
• Completion: 2020-04-28
• First posted: 2017-11-24
• Last updated: 2021-08-18
• Results posted: 2021-07-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study