Trials / Completed
CompletedNCT01765127
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
- Phase
- —
- Study type
- Observational
- Enrollment
- 122 (actual)
- Sponsor
- Professor Saad Shakir · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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
Timeline
- Start date
- 2012-01-01
- Primary completion
- 2017-02-01
- Completion
- 2018-01-01
- First posted
- 2013-01-10
- Last updated
- 2018-07-31
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT01765127. Inclusion in this directory is not an endorsement.