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Completed

NCT Number: NCT04173858

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

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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Key information

Conditions

Opioid-induced Constipation Chemically-Induced Disorders Constipation Mental Disorders Narcotic-Related Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario de Torrejon

Torrejón de Ardoz, Madrid, 28850, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Naloxegol

Drug

25 mg oral naloxegol once daily.

Primary outcomes

  1. Assessment of Quality of Life

    Time frame: 12 months

    Patient Assessment of Constipation Quality of Life (PAC-QoL) Questionnaire

Secondary outcomes

  1. Assessment of Constipation Symptoms

    Time frame: 15 days

    Patient Assessment of Constipation Symptoms (PAC-SYM) Questionnaire

  2. Assessment of Constipation Symptoms

    Time frame: 1 month

    Patient Assessment of Constipation Symptoms (PAC-SYM) Questionnaire

  3. Assessment of Constipation Symptoms

    Time frame: 3 months

    Patient Assessment of Constipation Symptoms (PAC-SYM) Questionnaire

  4. Assessment of Constipation Symptoms

    Time frame: 6 months

    Patient Assessment of Constipation Symptoms (PAC-SYM) Questionnaire

Sponsors and collaborators

Lead sponsor

Kyowa Kirin Farmacéutica S.L.U.

Industry

Registry information

Official study title

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

Acronym: KYONAL

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 22, 2019
Registry last updated
Nov 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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