NCT03316859

Naloxegol and Opioid-induced Constipation

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 280 (estimated)
• Sponsor: TriHealth Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Constipation
• Constipation Drug Induced

Interventions

Type	Name	Description
DRUG	Naloxegol 25 MG	Naloxegol 25 mg administered 1 hour pre-operatively
OTHER	Placebo pill	Placebo pill administered 1 hour pre-operatively

Timeline

• Start date: 2017-11-06
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2017-10-20
• Last updated: 2022-05-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study