Naloxegol and Opioid-induced Constipation

• Status: Recruiting
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Angela Fellner; TriHealth Inc.
• Collaborator: Emily Craver
• Treatments: Analgesics, Opioid; Naloxegol

Criteria

Inclusion Criteria:

• Scheduled to undergo elective cardiac surgery at Bethesda North TriHealth Hospital

• Admitted to Bethesda North TriHealth Hospital CVICU post-surgery

Exclusion Criteria:

• Medically unstable

• Cognitive deficits that impair the patient's ability to understand the informed consent

• Language barriers

• Patient has a documented diagnosis of one of the following: Crohn's disease; Ulcerative Colitis; History of bowel surgery that will impact absorption of study drug (as deemed by physician); History of small bowel obstruction

• Chronic constipation requiring subject to take one of the following medications on a daily basis prior to time of consent: Linzess, Trulance, Amitza, Senna/Senokot, Colace, Dulcolax, Miralax, Metamucil

• Patients on following medications prior to time of consent: Diltiazem, Verapamil, Amiodarone, Ketoconazole, Clarithromycin/ erythromycin, Antivirals

• Conditions that present an increased risk of bowel perforation (as determined by the physician)

• Pre-existing diagnosis of opioid-induced constipation AND receiving naloxegol as a treatment by their physician