Study of Ondansetron in the Prevention of Sleep Syncope: The Nineth Prevention of Syncope Trial (POST9)
Launched by UNIVERSITY OF CALGARY · Dec 12, 2022
Trial Information
Current as of January 16, 2025
Not yet recruiting
Keywords
ClinConnect Summary
Trial interventions: Randomization will be to ondansetron 8 mg sublingual tablets or matching placebo tablets kept at the bedside, to be used upon awakening with premonitory nausea. This is a commonly used dose for rapid treatment of nausea.
Randomization: Patients will be randomized into two treatment groups will be carried out centrally with a randomization scheme using a computerized algorithm. Medication containers will be filled and labelled with the randomization code number centrally. The investigators will complete a screening log of eligible but nonrandomized patients that will co...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Syncope according to the American College of Cardiology Guidelines 2017
- • 2. ≥1 Sleep Syncope in the year preceding enrolment
- • 3. ≥-2 points on the Calgary Syncope Symptom Score for Structurally Normal Hearts
- • 4. Age ≥ 18 years with informed consent.
- Exclusion Criteria:
- • 1. An inability to give informed consent
- • 2. pregnancy,
- • 3. unwilling or unable to use adequate birth control while on study drug
- • 4. QT interval exceeding 500 ms in the absence of correctable factors.
About University Of Calgary
The University of Calgary is a leading research institution dedicated to advancing health and science through innovative clinical trials. With a strong emphasis on multidisciplinary collaboration, the university's clinical research initiatives aim to address pressing health challenges and improve patient outcomes. The institution fosters a robust environment for academic inquiry, leveraging state-of-the-art facilities and a diverse network of experts in various fields. Committed to ethical research practices and community engagement, the University of Calgary strives to translate scientific discoveries into tangible benefits for society.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Calgary, Alberta, Canada
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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