Alvimopan Use in Polytraumatized Patients

NCT03068975 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2020-02-05

No results posted yet for this study

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

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-01
Primary Completion
2019-11-19
Completion
2019-11-19
FDA Drug
Yes

Countries

  • Puerto Rico

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03068975 on ClinicalTrials.gov