Naloxegol and Opioid-induced Constipation

April 29, 2022 updated by: TriHealth Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

280

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Naloxegol
naloxegol 25 mg pill
Drug: Naloxegol 25 MG
Naloxegol 25 mg administered 1 hour pre-operatively
Other Names:
  • Movantik
PLACEBO_COMPARATOR: Placebo
placebo pill
Other: Placebo pill
Placebo pill administered 1 hour pre-operatively

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to substantial bowel movement
Time Frame: Post-operative day 1
Time to bowel movement of Type 2 or higher on the Bristol stool chart
Post-operative day 1
Time to substantial bowel movement
Time Frame: Post-operative day 2
Time to bowel movement of Type 2 or higher on the Bristol stool chart
Post-operative day 2
Time to substantial bowel movement
Time Frame: Post-operative day 3
Time to bowel movement of Type 2 or higher on the Bristol stool chart
Post-operative day 3
Time to substantial bowel movement
Time Frame: Post-operative day 4
Time to bowel movement of Type 2 or higher on the Bristol stool chart
Post-operative day 4
Time to substantial bowel movement
Time Frame: Post-operative day 5
Time to bowel movement of Type 2 or higher on the Bristol stool chart
Post-operative day 5

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rescue medications
Time Frame: Post-operative day 1
Amount of rescue medications
Post-operative day 1
Rescue medications
Time Frame: Post-operative day 2
Amount of rescue medications
Post-operative day 2
Rescue medications
Time Frame: Post-operative day 3
Amount of rescue medications
Post-operative day 3
Rescue medications
Time Frame: Post-operative day 4
Amount of rescue medications
Post-operative day 4
Rescue medications
Time Frame: Post-operative day 5
Amount of rescue medications
Post-operative day 5

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of stay
Time Frame: Post-operative day 1
CVICU length of stay
Post-operative day 1
Length of stay
Time Frame: Post-operative day 2
CVICU length of stay
Post-operative day 2
Length of stay
Time Frame: Post-operative day 3
CVICU length of stay
Post-operative day 3
Length of stay
Time Frame: Post-operative day 4
CVICU length of stay
Post-operative day 4
Length of stay
Time Frame: Post-operative day 5
CVICU length of stay
Post-operative day 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TriHealth Inc.

Investigators

  • Principal Investigator: Scott McCardle, MD, Bethesda North TriHealth Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 6, 2017

Primary Completion (ANTICIPATED)

December 1, 2022

Study Completion (ANTICIPATED)

December 1, 2022

Study Registration Dates

First Submitted

October 17, 2017

First Submitted That Met QC Criteria

October 17, 2017

First Posted (ACTUAL)

October 20, 2017

Study Record Updates

Last Update Posted (ACTUAL)

May 5, 2022

Last Update Submitted That Met QC Criteria

April 29, 2022

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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