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

Kyowa Kirin

Status: Completed

Conditions: Opioid-induced Constipation

Treatments: Drug: Naloxegol

Study type: Observational

Funder types: Industry

Identifiers

NCT04173858

KYO-NAL-2017-01

Details and patient eligibility

About

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.

Enrollment: 126 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

126 participants in 1 patient group

Experimental

Description:

Patients with confirmed opioid-induced constipation diagnosis and inadequate response to laxatives.

Treatment:

Drug: Naloxegol