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Recruiting Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT04792034

Public ClinicalTrials.gov record NCT04792034. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 3, 2026, 6:34 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT04792034
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Noden Pharma
Industry
Enrollment
40 participants

Conditions and interventions

Eligibility (public fields only)

Age range
12 Years to 18 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 5, 2025
Primary completion
Nov 30, 2027
Completion
Dec 30, 2027
Last update posted
Dec 25, 2025

2025 – 2027

United States locations

U.S. sites
4
U.S. states
1
U.S. cities
2
Facility City State ZIP Site status
SCENT Sleep and Allergy, 110 Highland Center Drive Columbia South Carolina 29203 Recruiting
SCENT Sleep and Allergy, 145 Park Central Columbia South Carolina 29203 Recruiting
South Carolina ENT, Sleep and Allergy Columbia South Carolina 29212 Recruiting
SCENT Sleep and Allergy, 15 Exchange Dr. Lugoff South Carolina 29078 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04792034, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 25, 2025 · Synced Sep 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04792034 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →