NCT04792034

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Noden Pharma · Industry
• Sex: All
• Age: 12 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

GOPRELTO® and NUMBRINO™ (cocaine hydrochloride nasal solution, 4%) are approved anesthetic products in adults. The purpose of this study is to assess the pharmacokinetic (PK) properties, safety, tolerability, and dosing of GOPRELTO® and NUMBRINO™ each as an anesthetic for diagnostic procedures and surgeries on or through the mucous membranes of the nasal cavities in pediatric adolescent subjects. The primary objectives for each treatment of the study are: * To assess the safety and tolerability of GOPRELTO® and NUMBRINO™ nasal solution in pediatric adolescent subjects as an anesthetic for diagnostic procedures and surgeries on or through the mucous membranes of the nasal cavities, respectively. * To evaluate the PK properties and define the dosing for GOPRELTO® and NUMBRINO™ nasal solution, respectively, in pediatric adolescent subjects as an anesthetic for diagnostic procedures and surgeries on or through the mucous membranes of the nasal cavities.

Conditions

• ENT Disorder
• Nasal Procedures
• Nasal Anesthesia
• Nasal Mucosa Surgery

Interventions

Type	Name	Description
DRUG	Cocaine Hydrochloride Nasal Solution	Topical Anesthetic
DRUG	Cocaine Hydrochloride Nasal Solution	Topical Anesthetic

Timeline

• Start date: 2025-12-06
• Primary completion: 2027-12-01
• Completion: 2027-12-31
• First posted: 2021-03-10
• Last updated: 2025-12-26

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study