drugset / Trial / NCT03235739

Ancillary Effects of Oral Naloxegol (Movantik)

NCT03235739 ↗

Phase 4 Completed 136 enrolled The Cleveland Clinic
RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to find out whether oral Naloxegol can reduce the side effects of opioid painkillers following surgery. This study aims to explore whether Naloxegol can similarly reduce opioid-induced side effects in post-surgical patients. About 130 surgery patients will participate in this study which is being conducted at Cleveland Clinic Main Campus.

Timeline

Start
2017-10-01
Primary completion
2021-05-31
Completion
2022-05-23

Outcome

Missed primary endpoint

registry analysis (superiority test); Treatment-Naloxegol; p = 0.84; geometric mean ratio 0.90 (95% CI 0.32 to 2.55); Mixed Models Analysis NCT03235739 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Naloxegol Unknown 25 mg Oral

Indications