An Observational Modified Prescription-event Monitoring Study of Asenapine (Sycrest)

An Observational Post-Authorization Modified Prescription-Event Monitoring Safety Study to Monitor the Safety and Utilization of Asenapine (Sycrest) in the Primary Care Setting in England

This post-marketing Modified Prescription-Event Monitoring (M-PEM) safety study of asenapine (SYCREST®) is to be carried out by the Drug Safety Research Unit (DSRU) as part of the Risk Management Plan required by the Committee for Medicinal Products for Human Use (CHMP) to further investigate the safety profile of asenapine in clinical practice. The aim of this study is to proactively capture safety and drug utilisation data in the post-marketing phase of license approval of asenapine as prescribed to patients by general practitioners (GPs) in England. This data is obtained through the completion of questionnaires by GPs.

Study Overview

• Status: Completed
• Conditions: Bipolar I Disorder

• Study Type: Observational
• Enrollment (Actual): 122

Contacts and Locations

Study Locations

• United Kingdom
  • Hampshire
    • Southampton, Hampshire, United Kingdom, SO31 1AA
      • Drug Safety Research Unit (for data collation and analysis only)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients prescribed asenapine for any indication by NHS GPs in England.

Description

Inclusion Criteria:

• Patients prescribed asenapine for any indication by NHS GPs in England.
• Patients for whom a study questionnaire containing useful information has been returned, will be included in the study cohort regardless of the dose or frequency of administration of asenapine, and irrespective of whether any medicines are concurrently administered.

Exclusion Criteria:

• patient no longer registered with the practice
• patient for whom no information is provided on study questionnaire
• patients for whom information provided on study questionnaire relates to another antipsychotic drug
• patients for whom the index date is an improbable date (i.e. before market launch date)
• patients for whom the GP reports that the patient did not take or was never prescribed asenapine

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Asenapine; Patients prescribed asenapine for any indication by a National Health Service (NHS) general practitioner (GP) in England.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence rate of selected important identified and potential risks	Incidence rates of these risks will be quantified: Somnolence and sedation; Weight gain; Oral hypoaesthesia; Swelling of the tongue and throat; Allergic reactions (Type 1 hypersensitivity)	At least 3 months after drug is first prescribed.

Collaborators and Investigators

• Sponsor: Professor Saad Shakir
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Principal Investigator: Saad Shakir, Professor, Drug Safety Research Unit

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: December 18, 2012
• First Submitted That Met QC Criteria: January 8, 2013
• First Posted (Estimate): January 10, 2013

Study Record Updates

• Last Update Posted (Actual): July 31, 2018
• Last Update Submitted That Met QC Criteria: July 30, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: Asenapine ModPEM