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

This study is currently recruiting participants.
Verified October 2016 by Professor Saad Shakir, Drug Safety Research Unit, Southampton, UK
Sponsor:
ClinicalTrials.gov Identifier:
NCT01765127
First Posted: January 10, 2013
Last Update Posted: October 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Professor Saad Shakir, Drug Safety Research Unit, Southampton, UK
  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:


Further study details as provided by Professor Saad Shakir, 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. ]

    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: May 2017
Estimated Primary Completion Date: January 2017 (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01765127


Contacts
Contact: Saad Shakir, Professor 442380408600 saad.shakir@dsru.org

Locations
United Kingdom
Drug Safety Research Unit (for data collation and analysis only) Recruiting
Southampton, Hampshire, United Kingdom, SO31 1AA
Contact: Saad Shakir, Professor    00442380408600    saad.shakir@dsru.org   
Sponsors and Collaborators
Professor Saad Shakir
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Saad Shakir, Professor Drug Safety Research Unit
  More Information

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
First Submitted: December 18, 2012
First Posted: January 10, 2013
Last Update Posted: October 28, 2016
Last Verified: October 2016

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