Clinical trial NCT02813148: Naloxegol Drug Utilization Post Authorisation Safety Study
Official title: An Observational Post-Authorization Safety Study (PASS) of MOVENTIG® (Naloxegol) Drug Utilization in Selected European Populations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Opioid Induced Constipation
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-06-24
Enrollment: 17254
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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

Eligibility criteria: 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)

Exclusion Criteria:

* No exclusion criteria will be applied

Primary outcomes:
measure: discontinuation
timeFrame: can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years
measure: Switching
timeFrame: can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years
measure: Augmentation
timeFrame: can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years
measure: Restart
timeFrame: can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years
measure: Continuous Use
timeFrame: can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years
measure: Dose Change
timeFrame: can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Frankfurt am Main
country: Germany
facility: Research Site
city: Oslo
country: Norway
facility: Research Site
city: Mölndal
country: Sweden
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Kyowa Kirin, Inc.
name: Rob Swain
role: STUDY_DIRECTOR
References: