CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 24 enrolled
Drug / intervention
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%drug
Likely dose
Tetracaine HCl 3% and Oxymetazoline HCl 0.05% 0.2mLfrom 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/NCT01807624
NCT01807624Phase 2Completed
CompareCT.gov

The Pharmacokinetics Of Tetracaine, Para-Butylaminobenzoic Acid, And Oxymetazoline After Intranasal Administration Of The Highest Phase 3 Dose Of Kovacaine™ Mist To Healthy Volunteers

St. Renatus, LLC·interventional·Posted Mar 8, 2013·Updated Aug 30, 2017

In Brief

A Phase 2 clinical trial evaluating Tetracaine HCl 3% and Oxymetazoline HCl 0.05% for Anesthesia. Completed, enrolled 24 participants across 1 site.

Detailed Summary

The purpose of this study is to determine the pharmacokinetics/pharmacodynamics and safety of a nasal spray containing the anesthetic drug tetracaine in combination with oxymetazoline with blood draws over 24 hours.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnesthesia
CountriesUnited States
CollaboratorsTriligent International, Rho, Inc., Analytical Bio-Chemistry Laboratories, Inc.

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 8, 2013
Enrollment StartMar 1, 2013
Primary CompletionMar 1, 2013
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 13.3 years ago

Interventions

Tetracaine HCl 3% and Oxymetazoline HCl 0.05%drug

1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl (para-butylaminobenzoic acid or PABA is active metabolite)