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Pharmacokinetics, Safety, and Tolerability of GOPRELTO and NUMBRINO in Pediatric Nasal Procedures

NCT ID: NCT07287735

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-06

Study Completion Date

2026-12-25

Brief Summary

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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

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"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."

Conditions

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Nasal Procedures Nasal Anesthesia Nasal Mucosa Surgery

Keywords

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GOPRELTO NUMBRINO Cocaine Hydrochloride Nasal Solution Pediatric Local Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment (Two-arm - GOPRELTO vs. NUMBRINO)
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Name: GOPRELTO®

Single topical dose administered via cottonoid pledgets for 20 minutes.

Group Type ACTIVE_COMPARATOR

GOPRELTO®

Intervention Type DRUG

cocaine hydrochloride nasal solution 4%

Name: NUMBRINO™

Single topical dose administered via cottonoid pledgets for 20 minutes.

Group Type EXPERIMENTAL

NUMBRINO™

Intervention Type DRUG

cocaine hydrochloride nasal solution 4%

Interventions

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GOPRELTO®

cocaine hydrochloride nasal solution 4%

Intervention Type DRUG

NUMBRINO™

cocaine hydrochloride nasal solution 4%

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* • Age 12 to \<18 years

* Weight ≥10th percentile; BMI ≥5th percentile
* Oxygen saturation ≥98%
* Undergoing nasal diagnostic procedure or surgery
* Able to assent; parent/guardian able to provide consent
* Use of acceptable contraception (if applicable)

Exclusion Criteria

* History of seizure

* Hypersensitivity to cocaine or ester anesthetics
* Recent intranasal cocaine use
* Positive drug screen
* Use of prohibited medications (SSRIs, MAOIs, decongestants, stimulants, etc.)
* Cardiovascular disease, abnormal ECG
* Hepatic or renal disease
* Nasal mucosa trauma preventing pledget placement
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Omnivium Pharmaceuticals LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Dr. Robert Puchalski, Principal Investigator, MD

Role: CONTACT

Phone: South Carolina ENT, Allergy &

Email: [email protected]

Related Links

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https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209963lbl.pdf

Full Prescribing Information - GOPRELTO®

https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209575s000lbl.pdf

Full Prescribing Information - NUMBRINO™

Other Identifiers

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RA-VP-000-357

Identifier Type: -

Identifier Source: org_study_id

IND118527 and IND 106499

Identifier Type: OTHER

Identifier Source: secondary_id