NCT05755737 (POST 11) is a Phase 2 clinical trial of Ondansetron in Vasovagal Syncope (VVS), sponsored by University of Calgary.

Who is sponsoring NCT05755737?

NCT05755737 is sponsored by University of Calgary.

What drugs are being tested in NCT05755737?

Interventions in NCT05755737: Ondansetron, Placebo.

What condition does NCT05755737 study?

NCT05755737 studies Vasovagal Syncope (VVS), Syncope.

Is NCT05755737 still recruiting?

NCT05755737 is currently recruiting now. Last updated 10 May 2024.

Last reviewed 2024-05-10 · How we verify

NCT05755737: POST 11

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Proof of Principle Study of Ondansetron for the Prevention of Vasovagal Syncope: The Eleventh Prevention of Syncope Trial (POST11)

Recruiting now Phase 2 Last updated 10 May 2024

What this trial tests

Phase 2 trial testing Ondansetron in Vasovagal Syncope (VVS) in 70 participants. Currently enrolling.

Timeline

1 June 2023

Primary endpoint
31 December 2025

31 December 2026

Quick facts

Lead sponsor	University of Calgary
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	70
Start date	1 June 2023
Primary completion	31 December 2025
Estimated completion	31 December 2026
Sites	1 location across Canada

Drugs / interventions tested

Ondansetron (ondansetron) — full drug profile →
Placebo

Conditions studied

Vasovagal Syncope (VVS) — all drugs for Vasovagal Syncope (VVS) →
Syncope — all drugs for Syncope →

Sponsor

University of Calgary

Who can join

Adults 18 to 100, any sex, with Vasovagal Syncope (VVS) or Syncope. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

About 20% of adults faint recurrently. These patients are often highly symptomatic, have problems with employment and driving, can be injured, and have poor quality of life. There are few therapies that have withstood the test of randomized clinical trials. the investigators will conduct a prospective, randomized, parallel, double-blind, proof-of-concept study that tests the hypothesis that serotonin 5HT3 receptor inhibition with ondansetron prevents tilt-induced vasovagal syncope (VVS) and pre-syncope in patients with clinical VVS. A total of 70 patients with quantitative clinical diagnostic criteria for VVS and at least 1 syncopal spell in the preceding year will be randomized in a double-blind acute phase 2 study to ondansetron 8 mg PO BID x 2 doses or matching placebo. The endpoint will be presyncope or syncope associated with diagnostic hemodynamic changes. These data should provide useful preliminary data as a foundation on which to conduct a subsequent randomized clinical trial.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Ondansetron

Trials testing the same drug.

NCT06861010 — Evaluating the Safety and Efficacy of Ondansetron in the Prevention of Post Endoscopic Retrograde Cholangiopancreatograp · Phase 3 · recruiting
NCT07310563 — A Trial to Evaluate Interactions Between Antiemetic Medication and AMG 133 in Participants Living With Overweight or Obe · Phase 1 · completed
NCT06898268 — Efficacy and Safety of Ondansetron Versus Metaclopromide Treatment in Infants With Gastro Oesophageal Reflux · NA · completed
NCT06475846 — A Trial of HRS5580 in Prevention of Postoperative Nausea and Vomiting of Adults · Phase 2 · completed
NCT06390787 — The Efficacy of B6 and Metoclopramide Combination in Comparison With the Other Antiemetics · Phase 2, PHASE3 · completed

Other recruiting trials for Vasovagal Syncope (VVS)

Currently open trials in the same condition.

NCT07459478 — Assesment of the Clinical Benefit of Provocation on Tilt-table in SYNCope Patients, TiltSYNC-trial · NA · recruiting

Other University of Calgary trials

Trials by the same sponsor.

NCT06885996 — Psilocybin-assisted Therapy for Post-Traumatic Stress Disorder in Survivors of Intimate Partner Violence · Phase 2 · not yet recruiting
NCT05729503 — Effect of SPG Block for Patients With Anxiety at Electronic Dance Music Festivals · Phase 2 · not yet recruiting
NCT07463339 — Microbiome-guided Prophylaxis to Reduce Ventilator-Associated Pneumonia in Intensive Care Units: A Pilot Randomized Cont · Phase 2 · not yet recruiting
NCT07145645 — Topical Diclofenac vs.Oral Ibuprofen for MSK Pain in Children · Phase 3 · recruiting
NCT07280325 — Moxie Self-Management and Education Support Program · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05755737 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Calgary
Last refreshed: 10 May 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05755737.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing