Naloxegol and Opioid-induced Constipation

  • STATUS
    Recruiting
  • days left to enroll
    66
  • participants needed
    280
  • sponsor
    TriHealth Inc.
Updated on 10 May 2022
opioid
opioid-induced constipation
naloxegol

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.

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.

Details
Condition Constipation, Constipation Drug Induced
Treatment Naloxegol 25 MG, Placebo Pill
Clinical Study IdentifierNCT03316859
SponsorTriHealth Inc.
Last Modified on10 May 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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