NCT03068975

Alvimopan Use in Polytraumatized Patients

A Double Blind, Randomized, Parallel Design Study to Evaluate the Effectiveness of Post-operative Dose of Alvimopan(Entereg) in Preventing Post-operative Ileus in Poly-traumatized Patients

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: University of Puerto Rico · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of Alvimopan(12 mg) in recovery of bowel function in an emergency trauma setting without the pre-operative dosage in patients that will receive abdominal surgery.

Conditions

• Post Operative Ileus

Interventions

Type	Name	Description
DRUG	Alvimopan	Patients who sustained abdominal trauma with resection of bowel and anastomosis will receive Alvimopan ( post operative dose only) and will monitor for post operative ileus.
DRUG	Placebo	Patients who sustained abdominal trauma with resection of bowel and anastomosis will receive the Placebo Pill (post operative dose only) and will monitor for post operative ileus.

Timeline

• Start date: 2017-09-01
• Primary completion: 2019-11-19
• Completion: 2019-11-19
• First posted: 2017-03-03
• Last updated: 2020-02-05

Locations

1 site across 1 country: Puerto Rico

Regulatory

• FDA-regulated drug study