NCT04173858

Evaluation of the Quality of Life of Patients With Opioid-induced Constipation Under Treatment With Naloxegol

Evaluation of the Quality of Life of Patients With Opioid-induced Constipation Under Treatment With Naloxegol. A One-year Follow-up Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 126 (actual)
• Sponsor: Kyowa Kirin Farmacéutica S.L.U. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Opioid-induced constipation (OIC) is a common feature in patients treated with strong opioids. Such medication is often prescribed together with a laxative (osmotic, emollient), with effectiveness depending on the individual patient. Peripherally-acting, mu-opioid receptor antagonists (PAMORAs), such as Naloxegol, have proven to be effective against OIC in patients with inadequate response to laxatives without reducing opioid analgesic effect. However, evidence regarding efficacy and safety on patients with cancer is still scarce. The objective of this study was to analyze the efficacy of naloxegol in a real-world setting by assessing Quality of Life outcomes, and to obtain data on its safety in the long term in patients with cancer.

Conditions

• Opioid-induced Constipation

Interventions

Type	Name	Description
DRUG	Naloxegol	25 mg oral naloxegol once daily.

Timeline

• Start date: 2017-09-21
• Primary completion: 2019-10-31
• Completion: 2019-10-31
• First posted: 2019-11-22
• Last updated: 2019-11-22

Locations

1 site across 1 country: Spain

Regulatory

• FDA-regulated drug study