Naloxegol and Opioid-induced Constipation

Phase 2

• Conditions: Constipation; Constipation Drug Induced
• Interventions: Other: Placebo pill; Drug: Naloxegol 25 MG

• Registration Number: NCT03316859
• Lead Sponsor: TriHealth Inc.

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 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 Timeline

• Study First Submitted: 2017-10-17
• Study First Submitted QC: 2017-10-17
• Study First Posted: 2017-10-20
• Study Start: 2017-11-06
• Status Verified: 2021-06
• Last Update Submitted: 2022-04-29
• Last Update Posted: 2022-05-05
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 280

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo pill	placebo pill
Naloxegol	Naloxegol 25 MG	naloxegol 25 mg pill

Primary Outcome Measures

Name	Time	Method
Time to substantial bowel movement	Post-operative day 5	Time to bowel movement of Type 2 or higher on the Bristol stool chart

Secondary Outcome Measures

Name	Time	Method
Rescue medications	Post-operative day 5	Amount of rescue medications

Trial Locations

Locations (1)

Bethesda North TriHealth Hospital; 🇺🇸 Cincinnati, Ohio, United States