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Naloxegol and Opioid-induced Constipation

Constipation Clinical Trial

Official title:
A Prospective Randomized, Double-Blind Study to Evaluate the Addition of Naloxegol to the Pre-Op Regimen of the Cardiac Surgery Patient and Its Effect on Opioid-Induced Constipation

Clinical Trial Summary

This is a double-blind, randomized, placebo-controlled trial to examine the effectiveness of adding one 25mg dose of naloxegol to the cardiac surgery pre-operative regimen.

Clinical Trial Description

This is a double-blind, randomized, placebo-controlled trial to examine the effectiveness of adding one 25mg dose of naloxegol to the cardiac surgery pre-op regimen. There will be 140 subjects per study group. The patient and treating physician/nurse will be blinded as to which group the subject is assigned. On the day of surgery, subjects in both groups will complete a questionnaire to assess compliance with prescribed pre-operative regimen. Subjects in both groups will receive post-operative bowel regimen in the cardiovascular intensive care unit (CVICU) according to current standard of care, including procedures for rescue medications for constipation prevention and induction of a bowel movement. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03316859
Study type Interventional
Source TriHealth Inc.
Contact Jocelyn LaMar, BS
Phone 513-865-5072
Email Jocelyn_LaMar@trihealth.com
Status Recruiting
Phase Phase 2/Phase 3
Start date November 6, 2017
Completion date December 1, 2022
View Details
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