Naloxegol Drug Utilization Post Authorisation Safety Study

Study Overview
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Brief Summary
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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
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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: To describe the characteristics of patients prescribed naloxegol at time of first prescription (demographics, targeted comorbidities, targeted comedications, provider characteristics, and indication characteristics). 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

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

Conditions
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Opioid Induced Constipation

Intervention / Treatment
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* Drug: Naloxegol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient has at least 1 prescription of naloxegol in his/her medical record anytime during the study period. 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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Naloxegol|Non-interventional study of drug utilization|

What is the study measuring?
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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 |