An Observational Post-Authorization Safety Study (PASS) of MOVENTIG® (Naloxegol) Drug Utilization in Selected European Populations
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Opioid Induced Constipation
- Sponsor
- Kyowa Kirin Pharmaceutical Development Ltd
- Enrollment
- 17254
- Locations
- 1
- Primary Endpoint
- Augmentation
- Status
- Completed
- Last Updated
- last year
Overview
Brief 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.
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
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Augmentation
Time Frame: can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years
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
Restart
Time Frame: can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years
Presence (yes/no) of a patient restarting the prescription of naloxegol (after temporary discontinuation or treatment holiday)
discontinuation
Time Frame: can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years
Presence (yes/no) of a patient discontinuing naloxegol (i.e. permanently during the observation period)
Switching
Time Frame: can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years
Presence (yes/no) of a patient switching from naloxegol to other drug(s) potentially used by patients with opioid induced constipation (OIC)
Continuous Use
Time Frame: can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years
Presence (yes/no) of a patient continuously treated with naloxegol during the study period
Dose Change
Time Frame: can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years
Presence (yes/no) of a patient changing dosing of naloxegol