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

NCT04173858 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 126

Last updated 2019-11-22

No results posted yet for this study

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.

Conditions

  • Opioid-induced Constipation

Interventions

DRUG

Naloxegol

25 mg oral naloxegol once daily.

Sponsors & Collaborators

  • Kyowa Kirin Farmacéutica S.L.U.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-21
Primary Completion
2019-10-31
Completion
2019-10-31
FDA Drug
Yes

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04173858 on ClinicalTrials.gov