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Naloxegol Health Outcome Post Authorisation Safety Study

NCT02813369 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 10000

Last updated 2024-07-23

No results posted yet for this study

Summary

This post-authorization observational safety study (PASS) monitors clinically important identified and potential risks within a cohort of patients treated with naloxegol, including the occurrence of bowel perforation, acute myocardial infarction (MI), stroke, cardiovascular (CV)-specific mortality, all-cause mortality, hypertension, opioid withdrawal, abdominal pain, diarrhea, syncope, and change in pain severity. This study is part of a broader post-marketing commitment to augment routine evaluation of the safety profile of naloxegol in clinical practice.

Conditions

  • Opioid Induced Constipation

Interventions

DRUG

naloxegol

non-interventional study where patients are exposed to naloxegol during normal clinical practice

DRUG

non-PAMORA laxative

non-interventional study where patients are exposed to non-peripherally acting mu-opioid receptor antagonist (PAMORA) laxative

Sponsors & Collaborators

  • Kyowa Kirin Pharmaceutical Development Ltd

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2021-11-30
Completion
2021-11-30

Countries

  • Netherlands
  • United Kingdom

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 NCT02813369 on ClinicalTrials.gov