Naloxegol Drug Utilization Post Authorisation Safety Study

Opioid Induced Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02813148
• Other study ID #: D3820R00006
• Status: Completed
• Start date: August 2015
• Est. completion date: January 2020

Study information

• Verified date: April 2023
• Source: Kyowa Kirin Pharmaceutical Development Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17254
• Est. completion date: January 2020
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Constipation
• Opioid Induced Constipation
• Opioid-Induced Constipation

Intervention

Drug:
• Naloxegol
Non-interventional study of drug utilization

Locations

Country	Name	City	State
Germany	Research Site	Frankfurt am Main
Norway	Research Site	Oslo
Sweden	Research Site	Mölndal
United Kingdom	Research Site	London

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Kirin Pharmaceutical Development Ltd

Countries where clinical trial is conducted

Germany,  Norway,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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