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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.
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:
Exploratory objective:
1. To identify predictors of length of naloxegol use
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naloxegol | Drug | Non-interventional study of drug utilization |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Rob Swain | Kyowa Kirin, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Frankfurt am Main | Germany | ||||
| Research Site |
| ID | Term |
|---|---|
| D000079689 | Opioid-Induced Constipation |
| ID | Term |
|---|---|
| D003248 | Constipation |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000589308 | naloxegol |
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| Oslo |
| Norway |
| Research Site | Mölndal | Sweden |
| Research Site | London | United Kingdom |
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |