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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01765127

Enrollment

122

Registered

2013-01-10

Start date

2012-01-31

Completion date

2018-01-31

Last updated

2018-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar I Disorder

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Incidence rate of selected important identified and potential risks	At least 3 months after drug is first prescribed.	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)

Countries

United Kingdom

Outcome results