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An Open-label, Two-Arm, Pharmacokinetics, Safety, and Tolerability Study of a Single Topical Dose of GOPRELTO® Nasal Solution and a Single Dose of NUMBRINO™ Nasal Solution for the Induction of Local Anesthesia of the Mucous Membranes When Performing Diagnostic Procedures and Surgeries in Pediatric Subjects From ≥12 Years to <18 Years of Age

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Trial Profile

An Open-label, Two-Arm, Pharmacokinetics, Safety, and Tolerability Study of a Single Topical Dose of GOPRELTO® Nasal Solution and a Single Dose of NUMBRINO™ Nasal Solution for the Induction of Local Anesthesia of the Mucous Membranes When Performing Diagnostic Procedures and Surgeries in Pediatric Subjects From ≥12 Years to <18 Years of Age

Status: Recruiting
Phase of Trial: Phase IV

Latest Information Update: 29 Dec 2025

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At a glance

  • Drugs Cocaine (Primary)
  • Indications Anaesthesia
  • Focus Adverse reactions; Pharmacokinetics; Registrational
  • Sponsors Noden Pharma

Most Recent Events

  • 26 Dec 2025 Phase of the study is changed from phase 4 to phase 3. Study design is changed from Single Group Assignment to sequential, non-randomised. Upper age limit for inclusion is changed from 17 to 18 years, thus including adults also.
  • 26 Dec 2025 Planned number of patients changed from 20 to 40.
  • 26 Dec 2025 Planned End Date changed from 1 Dec 2021 to 31 Dec 2027.

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