MedTrace Logo

Real World Observational Study of Naloxegol for Patients With Cancer Pain Diagnosed With OIC.

NCT03638440 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 183

Last updated 2024-06-17

No results posted yet for this study

Summary

This is a single-arm, open label, multinational, multicentre, prospective, real world observational study of Naloxegol in adult subjects with Opioid Induced Constipation (OIC) in patients receiving Naloxegol in routine clinical practice. Subjects who are receiving Naloxegol (prescribed by their physician according to the SmPC, which recommends that all currently used maintenance laxative therapy should be halted) during the enrolment period may be eligible for enrolment into the study.

Conditions

  • Opioid Induced Constipation

Interventions

DRUG

Naloxegol

Naloxegol is a PEGylated derivative of the μ-opioid receptor antagonist naloxone

Sponsors & Collaborators

  • Apices Soluciones S.L.

    collaborator INDUSTRY

  • Kyowa Kirin Pharmaceutical Development Ltd

    lead INDUSTRY

Principal Investigators

  • Andrew Davies, MD · Royal Surrey County Hospital NHS Foundation Trust

  • Jan Tack, MD · University Hospital KU Leuven

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-16
Primary Completion
2020-03-05
Completion
2020-03-05
FDA Drug
Yes

Countries

  • Denmark
  • Finland
  • France
  • Germany
  • Greece
  • Italy
  • Netherlands
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

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 NCT03638440 on ClinicalTrials.gov