GOPRELTO and NUMBRINO nasal anesthetic for teens having nasal procedures

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

This study will test single doses of GOPRELTO and NUMBRINO nasal anesthetic solutions to see if they are safe and have appropriate dosing for teens aged 12–17 undergoing nasal diagnostic procedures or surgery.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 12 Years to 18 Years
• Sex: All
• Sponsor: Noden Pharma (Industry-sponsored)
• Locations: 4 sites (Columbia, South Carolina and 3 other locations)
• Trial ID: NCT04792034 on ClinicalTrials.gov

What this trial studies

This Phase 3 study gives a single dose of GOPRELTO® or NUMBRINO™ (cocaine hydrochloride 4% nasal solution) to adolescent subjects undergoing diagnostic procedures or surgery on the nasal mucosa and collects blood samples to define pharmacokinetics and dosing. Safety and tolerability measures, including vital signs and adverse event monitoring, are recorded after dosing. The trial enrolls participants aged 12 to under 18 who meet prespecified weight, BMI, and oxygen saturation criteria. Study sites are outpatient ENT clinics in Columbia, South Carolina, and the protocol follows pediatric assent and parent/guardian consent procedures.

Who should consider this trial

Good fit: Ideal candidates are nonpregnant, nonlactating adolescents aged 12 to <18 who will undergo a diagnostic procedure or surgery involving the nasal mucous membranes and meet the study's weight, BMI, and oxygen saturation requirements.

Not a fit: Patients younger than 12 or older than 17, pregnant or lactating individuals, those with contraindications to cocaine hydrochloride, or those who do not meet weight/BMI or oxygenation criteria are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, this could provide a tested single-dose nasal anesthetic option with defined pediatric dosing and safety data for teens needing nasal procedures.

How similar studies have performed: Both GOPRELTO® and NUMBRINO™ (cocaine hydrochloride 4%) are approved anesthetics in adults with supporting PK and safety data in adults, but pediatric PK and dosing data are limited, so this study extends established adult experience into adolescents.

Eligibility criteria

Inclusion Criteria:

A subject will be eligible for inclusion in the study if he or she meets all of the following criteria:

1. Is accompanied and/or represented by a parent or guardian able to comprehend and sign the informed consent document.
2. Is able to understand and provide assent to an age-appropriate subject assent form (as defined by local practice or regulation).
3. Subject or parent/guardian is able to communicate with the Investigator and comply with the requirements of the protocol.
4. Is male or female ≥12 to \<18 years of age at the time of dosing.
5. Is no lower than the 10th percentile for weight according to age.
6. Has a body mass index (BMI) no lower than the 5th percentile by age.
7. Has an oxygen saturation of at least 98%.
8. Will be undergoing a diagnostic procedure or surgery on or through the nasal mucous membranes of either one or both nostrils.
9. Is a non-pregnant, non-lactating female (if of child-bearing potential and sexually active) or is a male (if sexually active with a partner of child-bearing potential) who agrees to use a medically acceptable and effective birth control method from the time of the Screening Visit and then for 8 days following the last dose of GOPRELTO® nasal solution or NUMBRINO™ nasal solution administration. Medically acceptable methods of contraception that may be used by the participant and/or his/her partner include: abstinence, FDA-approved hormonal contraceptives (i.e., birth control pill, injection, patch or vaginal ring), diaphragm, intrauterine device, double-barrier methods, surgical sterilization, and progestin implant or injection. Prohibited methods include: the rhythm method or withdrawal.

Exclusion Criteria:

A subject will be excluded from the study if he or she meets any of the following criteria:

1. Has a history of seizure.
2. Has a known hypersensitivity allergy to any ester-based anesthetics including cocaine hydrochloride, procaine, tetracaine, chloroprocaine, dibucaine, or benzocaine, and/or any other compounds of the drugs and /or devices that are part of this protocol (amide based anesthetics are NOT exclusionary).
3. Has previously received intranasal topical cocaine within 14 days prior to the Screening Visit.
4. Has participated in an investigational study or received an investigational drug within 30 days preceding Treatment Day 1.
5. Has a history of abuse of controlled substances, nasal or otherwise.
6. Has a positive test result for drugs of abuse at the Screening Visit: amphetamines, barbiturates, cannabinoids, cocaine metabolites, opiates, and oxycodone via a urine test. Alcohol is prohibited within 24 hours prior to Treatment Day 1.
7. Is a pregnant female or nursing mother or has a positive urine pregnancy test at the Screening Visit or on Treatment Day 1.
8. Use of any serotonin-norepinephrine reuptake inhibitors/selective serotonin reuptake inhibitors (SNRIs/SSRIs) up to 14 days prior to the Screening Visit or has a need to use these drugs at any time throughout the duration of the study.
9. Use of monoamine oxidase inhibitor (MAO) drugs up to 14 days prior to the Screening Visit or has a need to use these drugs at any time throughout the duration of the study.
10. Use of nasal products such as decongestants (oxymetazoline, phenylephrine), amphetamines, stimulant prescription and nonprescription products such as catecholamines (direct and indirect-acting sympathomimetics), bronchial inhalers containing sympathomimetics (epinephrine or other beta-receptor agonists), or herbal products in the 2 days prior to the Screening Visit or has a need to use these drugs through or on Treatment Day 1.
11. Use of disulfiram.
12. Planned or anticipated need for additional vasoconstrictor agents such as epinephrine or phenylephrine.
13. Suffers from a condition, other than the need for a diagnostic procedure or surgery on or through the nasal mucous membranes, which in the opinion of the Investigator, would compromise the safety of the subject, the quality of the data, or the normal wound healing process.
14. Has severely traumatized mucosa or septum in the nasal cavities or has damage to the nasal space that will not allow pledgets to be inserted.
15. Has a recent or active history of myocardial infarction, coronary artery disease, congestive heart failure, unstable angina, or uncontrolled hypertension. Uncontrolled hypertension is defined as systolic blood pressure or diastolic blood pressure greater than or equal to the 95th percentile by sex, age and height.
16. Has an ECG finding of any abnormality at the Screening Visit. Generally, these exclusionary abnormalities are current or prior myocardial ischemia or infarction, dysrhythmia, or risk of serious dysrhythmia (such as prolonged QT interval). An exception to this would be if sinus bradycardia or sinus tachycardia is present. The Investigator must determine whether this finding is clinically significant and exclusionary.
17. Has a known personal or family history of hereditary pseudocholinesterase deficiency.
18. Has a known or suspected personal or family history of pheochromocytoma. Study participants will be specifically asked if they have been treated for a pheochromocytoma previously or if they have a family member who has been diagnosed with pheochromocytoma (as 10% of these are familial).
19. Has any laboratory result outside the normal laboratory reference range deemed clinically significant by the Investigator.
20. Has a history of, or current, hepatic or renal disease.
21. Is not suitable for entry into the study, in the opinion of the Investigator. Note: A one-time retest is permitted for any blood test if the original sample was hemolyzed.

Where this trial is running

Columbia, South Carolina and 3 other locations

• SCENT Sleep and Allergy, 110 Highland Center Drive — Columbia, South Carolina, United States (Recruiting)
• SCENT Sleep and Allergy, 145 Park Central — Columbia, South Carolina, United States (Recruiting)
• South Carolina ENT, Sleep and Allergy — Columbia, South Carolina, United States (Recruiting)
• SCENT Sleep and Allergy, 15 Exchange Dr. — Lugoff, South Carolina, United States (Recruiting)

Study contacts

• Study coordinator: Robert Puchlaski, M.D

Conditions ENT Disorder; Nasal Procedures; Nasal Anesthesia; Nasal Mucosa Surgery; Nasal; Sinus; ENT