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

Opioid-induced Constipation Clinical Trial

— KYONAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04173858
• Other study ID #: KYO-NAL-2017-01
• Status: Completed
• Start date: September 21, 2017
• Est. completion date: October 31, 2019

Study information

• Verified date: November 2019
• Source: Kyowa Kirin Farmacéutica S.L.U.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: October 31, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Constipation
• Opioid-induced Constipation

Intervention

Drug:
• Naloxegol
25 mg oral naloxegol once daily.

Locations

Country	Name	City	State
Spain	Hospital Universitario de Torrejon	Torrejón De Ardoz	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Kirin Farmacéutica S.L.U.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of Quality of Life	Patient Assessment of Constipation Quality of Life (PAC-QoL) Questionnaire	12 months
Secondary	Assessment of Constipation Symptoms	Patient Assessment of Constipation Symptoms (PAC-SYM) Questionnaire	15 days
Secondary	Assessment of Constipation Symptoms	Patient Assessment of Constipation Symptoms (PAC-SYM) Questionnaire	1 month
Secondary	Assessment of Constipation Symptoms	Patient Assessment of Constipation Symptoms (PAC-SYM) Questionnaire	3 months
Secondary	Assessment of Constipation Symptoms	Patient Assessment of Constipation Symptoms (PAC-SYM) Questionnaire	6 months