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

December 16, 2025 updated by: Omnivium Pharmaceuticals LLC

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.

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™.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Name: GOPRELTO®
Single topical dose administered via cottonoid pledgets for 20 minutes.
Drug: GOPRELTO®
cocaine hydrochloride nasal solution 4%
Experimental: Name: NUMBRINO™
Single topical dose administered via cottonoid pledgets for 20 minutes.
Drug: NUMBRINO™
cocaine hydrochloride nasal solution 4%

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time Frame: Day 1 through Day 8-10
Number of subjects experiencing at least one treatment-emergent adverse event after administration of study drug.
Day 1 through Day 8-10
Change in Systolic Blood Pressure From Pre-Dose
Time Frame: Pre-dose to 24 hours post-dose
Mean change from baseline in systolic blood pressure (mmHg).
Pre-dose to 24 hours post-dose
Change in Diastolic Blood Pressure From Pre-Dose
Time Frame: Pre-dose to 24 hours post-dose
Mean change from baseline in diastolic blood pressure (mmHg).
Pre-dose to 24 hours post-dose
Change in Heart Rate From Pre-Dose
Time Frame: Pre-dose to 24 hours post-dose
Mean change from baseline in heart rate (beats per minute).
Pre-dose to 24 hours post-dose
Change in Respiratory Rate From Pre-Dose
Time Frame: Pre-dose to 24 hours post-dose
Mean change from baseline in respiratory rate (breaths per minute).
Pre-dose to 24 hours post-dose
Change in Oxygen Saturation (SpO₂)
Time Frame: Pre-dose to 24 hours post-dose
Mean change in pulse oximetry oxygen saturation (% SpO₂).
Pre-dose to 24 hours post-dose
ECG QT Interval
Time Frame: Pre-dose to 24 hours post-dose
Mean QT interval (milliseconds) obtained from 12-lead ECG.
Pre-dose to 24 hours post-dose
ECG PR Interval
Time Frame: Pre-dose to 24 hours post-dose
Mean PR interval (milliseconds).
Pre-dose to 24 hours post-dose
ECG QRS Duration
Time Frame: Pre-dose to 24 hours post-dose
Mean QRS duration (milliseconds).
Pre-dose to 24 hours post-dose
Peak Plasma Concentration (Cmax) of Cocaine
Time Frame: Day 1 (pre-dose to end of PK sampling)
Maximum observed plasma concentration of cocaine (ng/mL)
Day 1 (pre-dose to end of PK sampling)
Time to Peak Concentration (Tmax) of Cocaine
Time Frame: Day 1 (pre-dose to end of PK sampling)
Time to reach maximum plasma concentration (hours).
Day 1 (pre-dose to end of PK sampling)
Area Under the Concentration-Time Curve (AUC₀-t) for Cocaine
Time Frame: Day 1 (pre-dose to end of PK sampling)
Area under the plasma concentration-time curve from time zero to last measurable concentration (ng·hr/mL).
Day 1 (pre-dose to end of PK sampling)
Area Under the Concentration-Time Curve (AUC₀-∞) for Cocaine
Time Frame: Day 1 (pre-dose to end of PK sampling)
AUC extrapolated to infinity (ng·hr/mL).
Day 1 (pre-dose to end of PK sampling)
Plasma Half-Life (t½) of Cocaine
Time Frame: Day 1 (pre-dose to end of PK sampling)
Elimination half-life (hours).
Day 1 (pre-dose to end of PK sampling)
Apparent Clearance (CL/F) of Cocaine
Time Frame: Day 1
Apparent plasma clearance (L/hour).
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Omnivium Pharmaceuticals LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 6, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 25, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 2, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 17, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 17, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RA-VP-000-357
  • IND118527 and IND 106499 (Other Identifier: U.S. IND number for each investigational product.)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings