NCT02813148

Naloxegol Drug Utilization Post Authorisation Safety Study

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 17,254 (actual)
• Sponsor: Kyowa Kirin Pharmaceutical Development Ltd · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The overall research questions for this study are: 1) What are the demographic, clinical, and treatment characteristics (including dose) at baseline of patients prescribed naloxegol in real-world practice (including the use of naloxegol in non-indicated populations)? and 2) What are the treatment patterns of naloxegol utilization during follow-up? Primary objectives: 1. To describe the characteristics of patients prescribed naloxegol at time of first prescription (demographics, targeted comorbidities, targeted comedications, provider characteristics, and indication characteristics). 2. To describe any of the following treatment patterns: * Discontinuation of naloxegol (permanently during the observation period) * Switching from naloxegol to other drug(s) potentially used by patients with opioid induced constipation (OIC) * Prescription of other drug(s) potentially used by patients with OIC in the same period when naloxegol is prescribed (augmentation) * Restart in the prescription of naloxegol (after temporary discontinuation or treatment holiday) * Continuous treatment with naloxegol during the study period * Change in dosing Exploratory objective: 1\. To identify predictors of length of naloxegol use

Conditions

• Opioid Induced Constipation

Interventions

Type	Name	Description
DRUG	Naloxegol	Non-interventional study of drug utilization

Timeline

• Start date: 2015-08-01
• Primary completion: 2019-06-01
• Completion: 2020-01-01
• First posted: 2016-06-24
• Last updated: 2024-07-23

Locations

4 sites across 4 countries: Germany, Norway, Sweden, United Kingdom