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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Merck
Information provided by (Responsible Party):
Professor Saad Shakir, Drug Safety Research Unit, Southampton, UK
ClinicalTrials.gov Identifier:
NCT01765127
First received: December 18, 2012
Last updated: January 8, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition
Bipolar I Disorder

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by NLM:

Drug Information available for: Asenapine
U.S. FDA Resources

Further study details as provided by Drug Safety Research Unit, Southampton, UK:

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: 5000
Study Start Date: January 2012
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Asenapine
Patients prescribed asenapine for any indication by a National Health Service (NHS) general practitioner (GP) in England.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients prescribed asenapine for any indication by NHS GPs in England.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01765127

Locations
United Kingdom
Drug Safety Research Unit (for data collation and analysis only)
Southampton, Hampshire, United Kingdom, SO31 1AA
Sponsors and Collaborators
Professor Saad Shakir
Merck
Investigators
Principal Investigator: Saad Shakir, Professor Drug Safety Research Unit
  More Information

No publications provided

Responsible Party: Professor Saad Shakir, Director, Drug Safety Research Unit, Southampton, UK
ClinicalTrials.gov Identifier: NCT01765127     History of Changes
Other Study ID Numbers: Asenapine ModPEM
Study First Received: December 18, 2012
Last Updated: January 8, 2013
Health Authority: European Union: European Medicines Agency

Additional relevant MeSH terms:
Asenapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on June 17, 2013