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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

126 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-21

Study Completion Date

2019-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Opioid-induced Constipation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Experimental

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

Naloxegol

Intervention Type DRUG

25 mg oral naloxegol once daily.

Interventions

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Naloxegol

25 mg oral naloxegol once daily.

Intervention Type DRUG

Eligibility Criteria

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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

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No