Recruiting
Phase 2
Phase 3

Naloxegol

Sponsor:

TriHealth Inc.

Code:

NCT03316859

Conditions

Constipation

Constipation Drug Induced

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Naloxegol 25 MG

Placebo pill

Study Details

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.

Conditions

Constipation

Constipation Drug Induced

Study ID

NCT03316859

Start date

Nov 6, 2017

Status verified date

Jun, 2021

Completion date

Dec 1, 2022

Anticipated

Primary completion date

Dec 1, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

280 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Naloxegol

naloxegol 25 mg pill

placebo comparator: Placebo

placebo pill

Interventions

Naloxegol 25 MG

Naloxegol 25 mg administered 1 hour pre-operatively

Placebo pill

Placebo pill administered 1 hour pre-operatively

Primary outcome measure

  • Time to substantial bowel movement [ Time Frame: Post-operative day 1 ]
  • Time to substantial bowel movement [ Time Frame: Post-operative day 2 ]
  • Time to substantial bowel movement [ Time Frame: Post-operative day 3 ]
  • Time to substantial bowel movement [ Time Frame: Post-operative day 4 ]
  • Time to substantial bowel movement [ Time Frame: Post-operative day 5 ]

Central Contacts and Locations

Central contacts

Jocelyn LaMar, BS

513-865-5072Jocelyn_LaMar@trihealth.com

Jennifer Perkins

513-865-1415jennifer_perkins@trihealth.com

Locations

Bethesda North TriHealth Hospital

Recruiting

Cincinnati, Ohio, United States, 45242

Contacts

Jocelyn LaMar, BS

513-865-5072Jocelyn_LaMar@trihealth.com

More Information

Sponsor

TriHealth Inc.

Last update posted

May 5, 2022

Last verified

Jun, 2021

Keywords

  • opioid-induced constipation (OIC)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by TriHealth Inc. on 2022-05-05.