Clinical trial

Real World Observational Study of Naloxegol for Patients With Cancer Pain Diagnosed With Opioid Induced Constipation.

Name

NACASY

Description

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.

Trial arms

Trial start

2018-08-16

Estimated PCD

2020-03-05

Trial end

2020-03-05

Status

Completed

Treatment

Naloxegol

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

Other names:

Moventig

Size

183

Primary endpoint

To assess the safety and efficacy of Naloxegol in a real world setting in cancer patients.

4 week treatment period

Eligibility criteria

Inclusion Criteria: * Patient ≥ 18 years old * Patient who is receiving treatment with opioids for at least 4 weeks, and is expected to remain on opioids for duration of study * Patient with opioid-induced constipation * Patient in whom the clinician plans treatment with Naloxegol according to routine clinical practice (Naloxegol SmPC recommends that all currently used maintenance laxative therapy should be halted) * Signing of the informed consent Exclusion Criteria: - Patients with colorectal cancer

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'OTHER', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 183, 'type': 'ACTUAL'}}

Updated at

2024-06-17

1 organization

1 product

1 indication

Organization

Kyowa Kirin Pharmaceutical Development

Product

Naloxegol

Indication

Opioid-Induced Constipation