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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: Recruiting Phase 3 study of ENT Disorder and Nasal Procedures, sponsored by Noden Pharma.
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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower). The trial reports 4 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Changes in blood pressure from baseline of 20 mmHg systolic or 15 mmHg diastolic OR when blood pressure reaches 150/90 mmHg in the automated blood pressure monitoring system during the mentioned time frame. Measurements will be taken in supine position with 3 measurements 5-6 minutes apart.
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 |
What NCT04792034 shows while recruiting
NCT04792034 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04792034's enrollment target sits among peer trials
40 1879th of 2000 higher than 103 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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