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

November 21, 2019 updated by: Kyowa Kirin Farmacéutica S.L.U.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

126

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Madrid
      • Torrejón De Ardoz, Madrid, Spain, 28850
        • Hospital Universitario De Torrejon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Ambulatory oncology patients in Spain with diagnosis of OIC.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Experimental
Patients with confirmed opioid-induced constipation diagnosis and inadequate response to laxatives.
Drug: Naloxegol
25 mg oral naloxegol once daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of Quality of Life
Time Frame: 12 months
Patient Assessment of Constipation Quality of Life (PAC-QoL) Questionnaire
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of Constipation Symptoms
Time Frame: 15 days
Patient Assessment of Constipation Symptoms (PAC-SYM) Questionnaire
15 days
Assessment of Constipation Symptoms
Time Frame: 1 month
Patient Assessment of Constipation Symptoms (PAC-SYM) Questionnaire
1 month
Assessment of Constipation Symptoms
Time Frame: 3 months
Patient Assessment of Constipation Symptoms (PAC-SYM) Questionnaire
3 months
Assessment of Constipation Symptoms
Time Frame: 6 months
Patient Assessment of Constipation Symptoms (PAC-SYM) Questionnaire
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyowa Kirin Farmacéutica S.L.U.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 21, 2017

Primary Completion (ACTUAL)

October 31, 2019

Study Completion (ACTUAL)

October 31, 2019

Study Registration Dates

First Submitted

November 18, 2019

First Submitted That Met QC Criteria

November 21, 2019

First Posted (ACTUAL)

November 22, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 22, 2019

Last Update Submitted That Met QC Criteria

November 21, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KYO-NAL-2017-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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