Status:
UNKNOWN
Naloxegol and Opioid-induced Constipation
Lead Sponsor:
TriHealth Inc.
Conditions:
Constipation
Constipation Drug Induced
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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.
Detailed 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 stu...
Eligibility Criteria
Inclusion
- Scheduled to undergo elective cardiac surgery at Bethesda North TriHealth Hospital
- Admitted to Bethesda North TriHealth Hospital CVICU post-surgery
Exclusion
- 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
Key Trial Info
Start Date :
November 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT03316859
Start Date
November 6 2017
End Date
December 1 2022
Last Update
May 5 2022
Active Locations (1)
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1
Bethesda North TriHealth Hospital
Cincinnati, Ohio, United States, 45242