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

Omnivium Pharmaceuticals LLC

Status and phase: Not yet enrolling; Phase 3

Conditions: Nasal Anesthesia; Nasal Procedures; Nasal Mucosa Surgery

Treatments: Drug: GOPRELTO®; Drug: NUMBRINO™

Study type: Interventional

Funder types: Industry

Identifiers

NCT07287735

IND118527 and IND 106499 (Other Identifier)

RA-VP-000-357

Details and patient eligibility

About

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™.

Full 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."

Enrollment: 40 estimated patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Name: GOPRELTO®

Active Comparator group

Description:

Single topical dose administered via cottonoid pledgets for 20 minutes.

Treatment:

Drug: GOPRELTO®

Name: NUMBRINO™

Experimental group

Description:

Single topical dose administered via cottonoid pledgets for 20 minutes.

Treatment:

Drug: NUMBRINO™