NCT03235739

Ancillary Effects of Oral Naloxegol (Movantik)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Opioids are the gold standard for postoperative pain management, but they have been shown to produce uncomfortable side effects such as urinary retention (an inability to completely empty the bladder), constipation and nausea/vomiting. Clinical evidence demonstrates that Naloxegol can safely and effectively block these undesirable side effects while maintaining the painkilling effects of opioids in outpatients suffering from opioid-induced constipation.

Conditions

• Pain, Postoperative

Interventions

Type	Name	Description
DRUG	Naloxegol 25 MG	Oral Naloxegol 25 MG
DRUG	Placebo	matching oral placebo

Timeline

• Start date: 2017-10-01
• Primary completion: 2021-05-31
• Completion: 2022-05-23
• First posted: 2017-08-01
• Last updated: 2023-09-05
• Results posted: 2023-09-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study