CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 143 enrolled
Drug / intervention
CPC - Capsaicin, Phenylephrine, Caffeine +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04972123
NCT04972123Phase 2Completed
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The Effect of Capsaicin-Phenylephrine-Caffeine Formulation on Aborting Tilt Induced Syncope in Patients With a History of Vasovagal Syncope or Near Syncope

University of Wisconsin, Madison·interventional·Posted Jul 22, 2021·Updated Jul 17, 2024

In Brief

A Phase 2 clinical trial evaluating CPC - Capsaicin, Phenylephrine, Caffeine, Tilt Table Test, and 1 other intervention for Syncope, Vasovagal. Completed, enrolled 143 participants across 1 site.

Detailed Summary

Syncope is defined as transient loss of consciousness associated with inability to maintain postural tone with rapid and spontaneous recovery. The purpose of this study is to assess the effects of sublingual administration of a new medication called CPC on tilt-induced syncope in patients with a history of vasovagal syncope (VVS) or near syncope. 140 participants will be randomized at the University of Wisconsin - Madison. Each participant will be in the study for 1 day.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSyncope, Vasovagal
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedJul 22, 2021
Enrollment StartJul 20, 2021
Primary CompletionAug 25, 2023
Study CompletionAug 31, 2023
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 4.9 years ago

Interventions

CPC - Capsaicin, Phenylephrine, Caffeinedrug

CPC is a combination of Capsaicin, Phenylephrine and Caffeine

Tilt Table Testother

Participant will undergo tilt tablet testing using the Italian protocol (see reference section). The Italian protocol includes 20 minutes of passive tilt at 70 degrees (Passive Phase) followed by nitroglycerin (NTG) administration and tilt testing for another 15 minutes (NTG Phase).

Placebodrug

Placebo for CPC