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
| Registry | NCT03316859 |
|---|---|
| Status | Unknown |
| Phase | Phase 2 / Phase 3 |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 280 (Estimated) |
| Sponsor | TriHealth Inc. (Other) |
| Conditions | Constipation, Constipation Drug Induced |
| Interventions | Naloxegol 25 MG, Placebo pill (Drug, other) |
| Dates | start 2017-11-06, primary completion 2022-12-01 (estimated), completion 2022-12-01 (estimated), first posted 2017-10-20, last updated 2022-05-05 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Constipation All trials for Constipation Drug Induced All trials of Naloxegol 25 MG All trials of Placebo pill
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Naloxegol | Experimental | Drug: Naloxegol 25 MG | naloxegol 25 mg pill |
| Placebo | Placebo comparator | Other: Placebo pill | placebo pill |
Sex: All, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| Bethesda North TriHealth Hospital | Cincinnati, Ohio | United States | Recruiting |