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

NCT04792034 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-12-26

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Cocaine Hydrochloride Nasal Solution

Topical Anesthetic

DRUG

Cocaine Hydrochloride Nasal Solution

Topical Anesthetic

Sponsors & Collaborators

  • Omnivium Pharmaceuticals LLC

    collaborator INDUSTRY

  • LXO Group

    collaborator INDUSTRY

  • Noden Pharma

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
12 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-06
Primary Completion
2027-12-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04792034 on ClinicalTrials.gov