Naloxegol Drug Utilization Post Authorisation Safety Study

Kyowa Kirin

Status: Completed

Conditions: Opioid Induced Constipation

Treatments: Drug: Naloxegol

Study type: Observational

Funder types: Industry

Identifiers

NCT02813148

D3820R00006

Details and patient eligibility

About

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.

Full 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

Enrollment: 17,254 patients

Sex: All

Volunteers: No Healthy Volunteers

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