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

NCT01765127 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 122

Last updated 2018-07-31

No results posted yet for this study

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

Sponsors & Collaborators

Principal Investigators

  • Saad Shakir, Professor · Drug Safety Research Unit

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2017-02-28
Completion
2018-01-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01765127 on ClinicalTrials.gov