Naloxegol and Opioid-induced Constipation

TriHealth

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Constipation Drug Induced; Constipation

Treatments: Drug: Naloxegol 25 MG; Other: Placebo pill

Study type: Interventional

Funder types: Other

Identifiers

NCT03316859

17-020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 280 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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280 participants in 2 patient groups, including a placebo group

Naloxegol

Experimental group

Description:

naloxegol 25 mg pill

Treatment:

Drug: Naloxegol 25 MG

Placebo

Placebo Comparator group

Description:

placebo pill

Treatment:

Other: Placebo pill