Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2025-12-25 @ 8:11 PM
Study NCT ID:
NCT07287735
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-17
First Post:
2025-12-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacokinetics, Safety, and Tolerability of GOPRELTO and NUMBRINO in Pediatric Nasal Procedures
Sponsor:
Omnivium Pharmaceuticals LLC
Organization:
Study Overview
Official Title:
An Open-label, Two-arm Study Evaluating Pharmacokinetics, Safety, and Tolerability of GOPRELTO and NUMBRINO Nasal Solutions in Pediatric Subjects Undergoing Nasal Diagnostic Procedures or Surgeries From ≥12 Years to <18 Years of Age.
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This open-label, two-arm, single-dose clinical study evaluates the pharmacokinetics, safety, and tolerability of GOPRELTO® (cocaine hydrochloride nasal solution 4%) and NUMBRINO™ (cocaine hydrochloride nasal solution 4%) in pediatric subjects aged 12 to \<18 years undergoing diagnostic procedures or surgeries on or through the nasal mucous membranes. Up to 20 subjects will receive GOPRELTO® and up to 20 will receive NUMBRINO™.
Detailed Description:
"GOPRELTO® and NUMBRINO™ are FDA-approved in adults for induction of local anesthesia of the mucous membranes during diagnostic procedures and surgeries. This Phase IIIb study assesses PK, safety, and tolerability in pediatric subjects using weight-based dosing applied via cottonoid pledgets. Plasma samples will be collected for PK, and standard safety assessments including vital signs, ECGs, pulse oximetry, laboratory tests, and adverse events will be performed."
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| IND118527 and IND 106499 | OTHER | U.S. IND number for each investigational product. | View |