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

Completed

• Conditions: Opioid-induced Constipation
• Interventions: Drug: Naloxegol

• Registration Number: NCT04173858
• Lead Sponsor: Kyowa Kirin Farmacéutica S.L.U.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-21
• Primary Completion: 2019-10-31
• Study Completion: 2019-10-31
• Status Verified: 2019-11
• Study First Submitted: 2019-11-18
• Study First Submitted QC: 2019-11-21
• Last Update Submitted: 2019-11-21
• Study First Posted: 2019-11-22
• Last Update Posted: 2019-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

• Diagnosis of Cancer
• Treatment with opioids
• OIC symptoms
• Inadequate response to laxatives
• Karnofsky equal or above 50
• Ambulatory
• Must be able to complete questionnaire forms

Exclusion Criteria

at the start of the study:

• Hypersensitivity to Naloxegol or vehicle
• Suspicion or high risk of gastrointestinal block
• High risk of GI perforation
• Severe liver failure
• Pregnancy or breastfeeding
• Use of potent CYP3A4 inhibitors
• Cognitive impairment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experimental	Naloxegol	Patients with confirmed opioid-induced constipation diagnosis and inadequate response to laxatives.

Primary Outcome Measures

Name	Time	Method
Assessment of Quality of Life	12 months	Patient Assessment of Constipation Quality of Life (PAC-QoL) Questionnaire

Secondary Outcome Measures

Name	Time	Method
Assessment of Constipation Symptoms	6 months	Patient Assessment of Constipation Symptoms (PAC-SYM) Questionnaire

Trial Locations

Locations (1)

Hospital Universitario de Torrejon; 🇪🇸 Torrejón De Ardoz, Madrid, Spain