NCT01952990

Safety and Pharmacokinetics of Kovacaine Nasal Spray in Pediatric Subjects

A Single-Center, Study Evaluating The Pharmacokinetics Of Tetracaine, Para-Butylaminobenzoic Acid, And Oxymetazoline After Intranasal Administration Of Kovacaine Mist To Healthy Pediatric Subjects

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: St. Renatus, LLC · Industry
• Sex: All
• Age: 3 Years – 17 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine the pharmacokinetics and safety of a nasal spray containing the anesthetic drug Tetracaine in combination with Oxymetazoline in healthy pediatric subjects.

Detailed description

The purpose of this study is to determine the pharmacokinetics and safety of tetracaine, para- butylaminobenzoic acid (PBBA), and oxymetazoline after intranasal administration of the recommended, weight-based Phase 3 dose of Kovacaine Mist (Tetracaine Hydrochloride with Oxymetazoline Hydrochloride) to healthy pediatric subjects. Kovacaine Mist is an anesthetic solution containing 3% tetracaine hydrochloride and 0.05% oxymetazoline hydrochloride. A single spray dose of 100 μL Kovacaine Mist contains 3 mg tetracaine HCl and 0.05 mg oxymetazoline HCl. A two-100 μL spray dose (a total of 200 μL) of Kovacaine Mist contains 6 mg tetracaine HCl and 0.1 mg oxymetazoline HCl. A two-200 μL spray dose (a total of 400 μL) of Kovacaine Mist contains 12 mg tetracaine HCl and 0.2 mg oxymetazoline HCl. Kovacaine Mist will be administered based on the weight of the subject as summarized in the table below. Subjects weighing 10 to \<20 kg will receive 1 intranasal spray of 100 μL of Kovacaine Mist at time D0. Subjects weighing 20 to \<40 kg will receive 2 intranasal sprays of 100 μL (total dose 200 μL) administered 4 minutes apart at times D0 and D4. Subjects weighing 40 kg or more will receive 2 intranasal sprays of 200 μL (total dose 400 μL) administered 4 minutes apart at times D0 and D4.

Conditions

• Anesthesia

Interventions

Type	Name	Description
DRUG	Tetracaine HCl 3% and Oxymetazoline HCl 0.05%	1 spray device is 0.2mL (200 μL) in volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl. Subjects receiving the 100 μL dose will receive half of the contents of one device using a dose divider. Subjects receiving the 200 μL dose will first receive half of the contents of one device using a dose divider and then 4 minutes later will receive the 2nd half by removing the dose divider. Subjects receiving the 400 μL dose will first receive the entire contents of one device and then 4 minutes later will receive the contents of a 2nd device.

Timeline

• Start date: 2013-09-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2013-09-30
• Last updated: 2015-06-08

Locations

1 site across 1 country: United States