Clinical trial

An Observational Post-Authorization Safety Study (PASS) of MOVENTIG® (Naloxegol) Drug Utilization in Selected European Populations

ID

Name

D3820R00006

Description

This post-authorization observational safety study determines the characteristics of patients prescribed naloxegol at time of first prescription and treatment patterns of naloxegol in follow-up in the United Kingdom (UK), Norway, Sweden, and Germany.

Trial arms

Trial start

2015-08-01

Estimated PCD

2019-06-01

Trial end

2020-01-01

Status

Completed

Treatment

Naloxegol

Non-interventional study of drug utilization

Size

17254

Primary endpoint

discontinuation

can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years

Switching

can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years

Augmentation

can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years

Restart

can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years

Continuous Use

can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years

Dose Change

can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years

Eligibility criteria

Inclusion Criteria: 1. The patient has at least 1 prescription of naloxegol in his/her medical record anytime during the study period. 2. The patient has at least 12 months of computerized records prior to the first prescription of naloxegol (index date) Exclusion Criteria: * No exclusion criteria will be applied

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 17254, 'type': 'ACTUAL'}}

Updated at

2023-04-10

1 organization

1 product

1 indication

Product

Indication

Opioid-Induced Constipation

Organization

Kyowa Kirin Pharmaceutical Development