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NCT04792034 · ClinicalTrials.gov registry record · Phase 3
Pharmacokinetics, Safety, and Tolerability Study of GOPRELTO® Nasal Solution and NUMBRINO™ Nasal Solution
A Phase 3 study of ENT Disorder and Nasal Procedures, sponsored by Noden Pharma.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 40
- Enrollment target
- 4
- Study locations
NCT04792034 is a Phase 3 study of ENT Disorder and Nasal Procedures that is actively recruiting participants, run by Noden Pharma. The registered enrollment target is 40 participants. The trial reports 4 study locations across 1 state.
The verdict
NCT04792034, a Phase 3 study of ENT Disorder and Nasal Procedures, is actively recruiting participants, sponsored by Noden Pharma.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 40 participants
- Enrollment target
- 4
- Study locations
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 Studied
Interventions
- DRUG Cocaine Hydrochloride Nasal Solution
Study Locations (4)
South Carolina
- SCENT Sleep and Allergy, 110 Highland Center Drive - Columbia
- SCENT Sleep and Allergy, 145 Park Central - Columbia
- South Carolina ENT, Sleep and Allergy - Columbia
- SCENT Sleep and Allergy, 15 Exchange Dr. - Lugoff
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2025-12-06 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04792034
The ClinicalTrials.gov registry entry for NCT04792034 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Noden Pharma, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with ENT Disorder appearing as the primary indexed condition, and to 1 intervention - of which Cocaine Hydrochloride Nasal Solution is the first listed.
NCT04792034 reports 4 study locations spanning 1 distinct geographic area - top geographies include South Carolina.
Frequently Asked Questions
What is clinical trial NCT04792034 about?
NCT04792034 is a clinical study titled "Pharmacokinetics, Safety, and Tolerability Study of GOPRELTO® Nasal Solution and NUMBRINO™ Nasal Solution". 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 adolesce...
What is the current status of trial NCT04792034?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 40 participants. The study started on 2025-12-06. Estimated completion is 2027-12-31.
What conditions does trial NCT04792034 study?
This clinical trial studies the following conditions: ENT Disorder, Nasal Procedures, Nasal Anesthesia, Nasal Mucosa Surgery.
What interventions are being tested in trial NCT04792034?
The interventions under investigation include: Cocaine Hydrochloride Nasal Solution (DRUG).
Who is sponsoring clinical trial NCT04792034?
This trial is sponsored by Noden Pharma, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04792034 being conducted?
This trial has 4 study locations across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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