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

Bipolar I Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01765127
• Other study ID #: Asenapine ModPEM
• Status: Completed
• Start date: January 2012
• Est. completion date: January 2018

Study information

• Verified date: July 2018
• Source: Drug Safety Research Unit, Southampton, UK
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: January 2018
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Bipolar I Disorder

Locations

Country	Name	City	State
United Kingdom	Drug Safety Research Unit (for data collation and analysis only)	Southampton	Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
Professor Saad Shakir	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.