An Observational Modified Prescription-event Monitoring Study of Asenapine (Sycrest)
This study is ongoing, but not recruiting participants.
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Professor Saad Shakir, Drug Safety Research Unit, Southampton, UK
First received: December 18, 2012
Last updated: January 8, 2013
Last verified: January 2013
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.
||Observational Model: Cohort
Time Perspective: Retrospective
||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
Primary Outcome Measures:
- Incidence rate of selected important identified and potential risks [ Time Frame: At least 3 months after drug is first prescribed. ] [ Designated as safety issue: Yes ]
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)
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||January 2015 (Final data collection date for primary outcome measure)
Patients prescribed asenapine for any indication by a National Health Service (NHS) general practitioner (GP) in England.
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patients prescribed asenapine for any indication by NHS GPs in England.
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01765127
|Drug Safety Research Unit (for data collation and analysis only)
|Southampton, Hampshire, United Kingdom, SO31 1AA |
Professor Saad Shakir
Merck Sharp & Dohme Corp.
||Saad Shakir, Professor
||Drug Safety Research Unit
No publications provided
||Professor Saad Shakir, Director, Drug Safety Research Unit, Southampton, UK
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 18, 2012
||January 8, 2013
||European Union: European Medicines Agency
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 17, 2014
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents