Alvimopan Use in Polytraumatized Patients
NCT03068975 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 3
Last updated 2020-02-05
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
-
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
- collaborator INDUSTRY
-
University of Puerto Rico
lead OTHER
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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