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5HT3 Receptor Inhibitor

Ondansetron for Fainting Prevention (POST 11 Trial)

Phase 2

Waitlist Available

Research Sponsored by University of Calgary

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥18 years with informed consent

≥1 syncopal spells in the year preceding enrolment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 12 months period of the study

Awards & highlights

POST 11 Trial Summary

This trial will study the use of a drug to reduce symptoms and improve quality of life for people with recurrent fainting episodes.

Who is the study for?

This trial is for adults who have fainted at least once in the past year and score ≥-2 on a specific fainting symptom scale. Participants must be over 18, able to consent, and not have other causes of fainting like heart issues or low blood pressure. Pregnant women, those with glaucoma, or people on certain medications can't join.Check my eligibility

What is being tested?

The study tests if Ondansetron (a drug that blocks certain serotonin receptors) can prevent fainting when standing up due to vasovagal syncope. It's a double-blind test where half the patients get Ondansetron and half get a placebo without knowing which one they're taking.See study design

What are the potential side effects?

Ondansetron may cause headaches, constipation or diarrhea, dizziness, and fatigue. Some might experience allergic reactions or changes in heartbeat but this is less common.

POST 11 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years or older and can give informed consent.

Select...

I have fainted at least once in the past year.

POST 11 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 12 months period of the study

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 12 months period of the study

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 12 months period of the study for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time to syncope or presyncope

Secondary outcome measures

Hospital Anxiety and Depression Scale (HADS)

RAND-36

cardiac output

+3 more

POST 11 Trial Design

2Treatment groups

Active Control

Group I: OndansetronActive Control1 Intervention

2 doses of Ondansetron 8mg PO (evening before and morning of study)

Group II: PlaceboActive Control1 Intervention

2 doses of matching placebo 8 mg PO (evening before and morning of study)

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of CalgaryLead Sponsor

792 Previous Clinical Trials

869,084 Total Patients Enrolled

Media Library

Ondansetron (5HT3 Receptor Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05755737 — Phase 2

Fainting Research Study Groups: Ondansetron, Placebo

Fainting Clinical Trial 2023: Ondansetron Highlights & Side Effects. Trial Name: NCT05755737 — Phase 2

Ondansetron (5HT3 Receptor Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05755737 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are seniors aged 60 and above permitted to participate in this trial?

"Patients enrolled in this study must be over 18 years old and under 100."

Answered by AI

Is enrollment open for this research initiative?

"This research trial is accepting approximately 70 individuals who have fainting episodes and are aged between 18 to 100."

Answered by AI

Does the FDA sanction the use of Ondansetron?

"While efficacy has yet to be confirmed, ondansetron's safety is supported by a few studies. Consequently, our team at Power graded it as a 2 out of 3."

Answered by AI

Is it still feasible for an individual to join this research endeavor?

"According to information found on clinicaltrials.gov, this trial has ceased recruitment efforts since March 2nd of 2023. Despite the lack of enrollment for this particular study, there are presently 26 other trials seeking participants in its place."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "A Proof of Principle Study of Ondansetron for the Prevention of Vasovagal Syncope: The Eleventh Prevention of Syncope Trial (POST11)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05755737.