Naloxegol Drug Utilization Post Authorisation Safety Study
- Conditions
- Opioid Induced Constipation
- Registration Number
- NCT02813148
- Lead Sponsor
- Kyowa Kirin Pharmaceutical Development Ltd
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 17254
- 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)
- No exclusion criteria will be applied
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Augmentation 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 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 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 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 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 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Research Site
🇬🇧London, United Kingdom