Naloxegol Drug Utilization Post Authorisation Safety Study

NCT02813148 | Completed

• 1 other identifier: D3820R00006
• Study Type: observational
• Target: 17,254
• Locations: 4 countries
• Sites: 4

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.

Conditions

Opioid Induced Constipation

Outcome Measures

Primary Outcomes (6)

• 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

Interventions

Naloxegol DRUG

Non-interventional study of drug utilization

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

Sponsors & Collaborators

• Kyowa Kirin Pharmaceutical Development Ltd: lead

Study Sites (4)

Research Site

Frankfurt am Main, Germany

Location

Research Site

Oslo, Norway

Location

Research Site

Mölndal, Sweden

Location

Research Site

London, United Kingdom

Location

MeSH Terms

Conditions

Opioid-Induced Constipation

Interventions

naloxegol

Condition Hierarchy (Ancestors)

Constipation; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Rob Swain

  Kyowa Kirin, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2016
• First Posted: June 24, 2016
• Study Start: August 1, 2015
• Primary Completion: June 1, 2019
• Study Completion: January 1, 2020
• Last Updated: July 23, 2024

Record last verified: 2024-07

Locations

GB (1); DE (1); NO (1); SE (1)