RecruitingPhase 3NCT04792034

Pharmacokinetics, Safety, and Tolerability Study of GOPRELTO® Nasal Solution and NUMBRINO™ Nasal Solution

An Open-label, Two-Arm, Pharmacokinetics, Safety, and Tolerability Study of a Single Topical Dose of GOPRELTO® Nasal Solution and a Single Dose of NUMBRINO™ Nasal Solution for the Induction of Local Anesthesia of the Mucous Membranes When Performing Diagnostic Procedures and Surgeries in Pediatric Subjects From ≥12 Years to <18 Years of Age

Sponsor

Noden Pharma

Enrollment

40 participants

Start Date

Dec 6, 2025

Study Type

INTERVENTIONAL

Conditions

ENT Disorder Nasal Procedures Nasal Anesthesia Nasal Mucosa Surgery

Summary

The purpose of this study is to assess the pharmacokinetic (PK) properties, safety and tolerability following a single dose administration of GOPRELTO® or NUMBRINO™ as an anesthetic for diagnostic procedures and surgeries on or through the mucous membranes of the nasal cavities in pediatric adolescent subjects.

Eligibility

Min Age: 12 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Cocaine Hydrochloride Nasal Solution and a drug called Cocaine Hydrochloride Nasal Solution for people with ent disorder, nasal anesthesia, and other related conditions. The study is currently recruiting participants at 4 locations. People eligible for this study include aged 12 Years to 18 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCocaine Hydrochloride Nasal Solution

Topical Anesthetic

DRUGCocaine Hydrochloride Nasal Solution

Topical Anesthetic

Locations(4)

SCENT Sleep and Allergy, 110 Highland Center Drive

Columbia, South Carolina, United States

SCENT Sleep and Allergy, 145 Park Central

Columbia, South Carolina, United States

South Carolina ENT, Sleep and Allergy

Columbia, South Carolina, United States

SCENT Sleep and Allergy, 15 Exchange Dr.

Lugoff, South Carolina, United States

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NCT04792034