Naloxegol Drug Utilization Post Authorisation Safety Study

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

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.

Study Overview

• Status: Completed
• Conditions: Opioid Induced Constipation
• Intervention / Treatment: Drug: Naloxegol

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

• Study Type: Observational
• Enrollment (Actual): 17254

Contacts and Locations

Study Locations

• Germany
  • Frankfurt am Main, Germany
    • Research Site
• Norway
  • Oslo, Norway
    • Research Site
• Sweden
  • Mölndal, Sweden
    • Research Site
• United Kingdom
  • London, United Kingdom
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients in the targeted countries who are newly prescribed naloxegol will be identified for inclusion. Patients analyzed in this study will be those who have at least 12 months of continuous data available prior to first prescription. The number of patients who do not have at least 12 months of prior data will be reported for completeness.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
discontinuation	Presence (yes/no) of a patient discontinuing naloxegol (i.e. permanently during the observation period)	can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years
Switching	Presence (yes/no) of a patient switching from naloxegol to other drug(s) potentially used by patients with opioid induced constipation (OIC)	can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years
Augmentation	Presence (yes/no) of a patient augmenting therapy with a prescription of other drug(s) potentially used by patients with OIC in the same period when naloxegol is prescribed	can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years
Restart	Presence (yes/no) of a patient restarting the prescription of naloxegol (after temporary discontinuation or treatment holiday)	can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years
Continuous Use	Presence (yes/no) of a patient continuously treated with naloxegol during the study period	can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years
Dose Change	Presence (yes/no) of a patient changing dosing of naloxegol	can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years

Collaborators and Investigators

• Sponsor: Kyowa Kirin Pharmaceutical Development Ltd
• Investigators: Study Director: Rob Swain, Kyowa Kirin, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2015
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): January 1, 2020

Study Registration Dates

• First Submitted: June 6, 2016
• First Submitted That Met QC Criteria: June 22, 2016
• First Posted (Estimated): June 24, 2016

Study Record Updates

• Last Update Posted (Actual): July 23, 2024
• Last Update Submitted That Met QC Criteria: July 22, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Signs and Symptoms, Digestive; Narcotic-Related Disorders; Constipation; Opioid-Induced Constipation; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Narcotic Antagonists; Naloxegol
• Other Study ID Numbers: D3820R00006