Naloxegol Drug Utilization Post Authorisation Safety Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

17254 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-08-31

Study Completion Date

2020-01-31

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.

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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:

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

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Opioid Induced Constipation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Naloxegol

Non-interventional study of drug utilization

Intervention Type DRUG

Eligibility Criteria

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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)

Eligible Sex

ALL

Accepts Healthy Volunteers

No