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Completed

NCT Number: NCT02813148

Naloxegol Drug Utilization Post Authorisation Safety Study

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Frankfurt am Main, Germany

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About this study

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:

  • To describe the characteristics of patients prescribed naloxegol at time of first prescription (demographics, targeted comorbidities, targeted comedications, provider characteristics, and indication characteristics).
  • 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:

  • To identify predictors of length of naloxegol use

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Naloxegol

Drug

Non-interventional study of drug utilization

Primary outcomes

  1. 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)

  2. 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)

  3. 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

  4. 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)

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

Kyowa Kirin Pharmaceutical Development Ltd

Industry

Registry information

Official study title

An Observational Post-Authorization Safety Study (PASS) of MOVENTIG® (Naloxegol) Drug Utilization in Selected European Populations

Important dates

Study start
2015
Primary completion
2019
Study completion
2020
First posted
Jun 24, 2016
Registry last updated
Jul 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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