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

NCT01765127 | Completed

• 1 other identifier: Asenapine ModPEM
• Study Type: observational
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar I Disorder

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Asenapine

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

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 prescribed asenapine for any indication by NHS GPs in England.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Professor Saad Shakir: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Drug Safety Research Unit (for data collation and analysis only)

Southampton, Hampshire, SO31 1AA, United Kingdom

Location

Study Officials

• Saad Shakir, Professor

  Drug Safety Research Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: December 18, 2012
• First Posted: January 10, 2013
• Study Start: January 1, 2012
• Primary Completion: February 1, 2017
• Study Completion: January 1, 2018
• Last Updated: July 31, 2018

Record last verified: 2018-07

Locations

GB (1)