A Phase 3 interventional study of Cocaine Hydrochloride Nasal Solution and Cocaine Hydrochloride Nasal Solution in ENT Disorder, Nasal Procedures and Nasal Anesthesia, sponsored by LXO Ireland. Recruiting at 6 sites in United States. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by LXO Ireland · Phase 3, Interventional, and Prevention
The purpose of this study is to assess the pharmacokinetic (PK) properties, safety and tolerability following a single dose administration of GOPRELTO® or NUMBRINO™ as an anesthetic for diagnostic procedures and surgeries on or through the mucous membranes of the nasal cavities in pediatric adolescent subjects.
GOPRELTO® and NUMBRINO™ (cocaine hydrochloride nasal solution, 4%) are approved anesthetic products in adults. The purpose of this study is to assess the pharmacokinetic (PK) properties, safety, tolerability, and dosing of GOPRELTO® and NUMBRINO™ each as an anesthetic for diagnostic procedures and surgeries on or through the mucous membranes of the nasal cavities in pediatric adolescent subjects.
The primary objectives for each treatment of the study are:
219 studies on the registry are indexed under Fistula; 49 are open to participants now.
This study's planned enrollment of 40 is below the median of 50 across 152 interventional studies indexed under Fistula.
Browse Fistula studies →This is the only study on the registry with LXO Ireland as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
A subject will be eligible for inclusion in the study if he or she meets all of the following criteria:
Exclusion Criteria:
A subject will be excluded from the study if he or she meets any of the following criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FDA Approved GOPRELTO® (cocaine hydrochloride nasal solution, 4%); Up to 160 mg depending on subject's weight; Saturated cottonoid pledgets are applied topically in both nostrils by study personnel
Drug: Cocaine Hydrochloride Nasal Solution
FDA Approved NUMBRINO™ (cocaine hydrochloride nasal solution, 4%); Up to 160 mg depending on subject's weight; Saturated cottonoid pledgets are applied topically in both nostrils by study personnel
Drug: Cocaine Hydrochloride Nasal Solution
Topical Anesthetic
Also known as: GOPRELTO®
Topical Anesthetic
Also known as: NUMBRINO™
Changes in Blood pressure
Changes in blood pressure from baseline of 20 mmHg systolic or 15 mmHg diastolic in the automated blood pressure monitoring system during the mentioned time frame. Measurements will be taken in supine position with 3 measurements 5-6 minutes apart.
Time frame: Baseline and every 5 minutes through 90 minutes post-pledget application.
Changes in Heart rate
Increase in heart rate from baseline of 20 bpm OR when heart rate of 125 bpm is reached at any point in the automated vital sign monitoring system during the mentioned time frame.
Time frame: Baseline and every 5 minutes through 90 minutes post-pledget application.
Changes in Respiratory Rate
Any changes in respiratory rate (increase or decrease) while on study medication.
Time frame: Baseline and every 5 minutes through 90 minutes post-pledget application.
Physical examination
Assessment of skin, head, ears, eyes, nose, throat, neck, thyroid, lungs, heart, cardiovascular, abdomen, lymph nodes, and musculoskeletal system/extremities; oral temperature, height, weight; BMI as well as height and weight percentiles.
Time frame: Screening Visit
Electrocardiogram
Any changes or delays in heart rhythm while on medication. Electrocardiogram will be performed in the supine position.
Time frame: Screening Visit, and on Day 1 at Baseline (pre-dose), continuously during treatment, and through 90 minutes post-pledget application
Pulse Oximetry
Any changes in the amount of oxygen in the blood while on study medication.
Time frame: Screening Visit, and on Day 1 at Baseline (pre-dose), every 5 minutes during treatment, and through 90 minutes post-pledget application
Incidence of Adverse events (AEs)
The number and percentage of subjects with AEs, AEs severity, causality, Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs).
Time frame: From Day 1 (pledget application) through the final follow-up call at Day 10.
Maximum observed plasma concentration (Cmax)
Measurement of the amount of the study medication (cocaine topical solution) in the blood over 8 hours to define the Cmax.
Time frame: Screening Visit, Baseline (pre-dose), 20, 40, 60, and 90 minutes, and 2, 4, and 8 hours after pledget application.
Time to maximum observed plasma concentration (Tmax)
Measurement of the time it takes after dosing for the study medication (cocaine topical solution) to reach its highest observed concentration in the blood over 8 hours.
Time frame: Screening Visit, Baseline (pre-dose), 20, 40, 60, and 90 minutes, and 2, 4, and 8 hours after pledget application.
Area under the plasma concentration versus time curve from time of dosing (0) to the time of last quantifiable concentration (AUClast)
Measurement of the amount of the study medication (cocaine topical solution) in the blood over 8 hours to define the AUC.
Time frame: Screening Visit, Baseline (pre-dose), 20, 40, 60, and 90 minutes, and 2, 4, and 8 hours after pledget application.
Area under the plasma concentration versus time curve from time of dosing (0) to infinity (AUCinf)
Measurement of the total exposure to the study medication in the blood over 8 hours, starting from dosing and extrapolated to infinity.
Time frame: Screening Visit, Baseline (pre-dose), 20, 40, 60, and 90 minutes, and 2, 4, and 8 hours after pledget application.
Terminal rate constant in plasma from the negative of the regression line slope through the ln-plasma concentration versus time data defining the terminal phase [kel (λz)]
Measurement of the time it takes for the concentration of the study medication in the blood to decrease by half during the terminal elimination phase, over 8 hours, calculated using kel as ln(2)/kel.
Time frame: Screening Visit, Baseline (pre-dose), 20, 40, 60, and 90 minutes, and 2, 4, and 8 hours after pledget application.
Terminal half-life in plasma calculated from the kel as ln(2)/kel (t½)
Measurement of the rate at which the study medication is eliminated from the blood during the terminal phase, calculated from the slope of the log-transformed concentration versus time data.
Time frame: Baseline (pre-dose), 20, 40, 60, and 90 minutes, and 2, 4, and 8 hours after pledget application.
Application Site Assessment
A visual nasal examination to determine if irritation is present at the application site.
Time frame: Screening Visit, Day 1 before drug application (Baseline), and within 90 minutes following the completion of the procedure.
Pediatric Smell Wheel
Assessment of smell (pre-dose and post-dose smell tests).
Time frame: Screening Visit and 90 minutes post-procedure on Day 1.
Assessment of Analgesia and Anesthesia
Assessment of analgesia and anesthesia will be conducted using a monofilament (Von Frey filament).
Time frame: Screening Visit and on Day 1 (following pledget removal but prior to procedure).
Pledget size assessment
A pledget size assessment will be conducted to assess the appropriate size pledget to administer study drug.
Time frame: Screening Visit and Day 1 (pre-dose).
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Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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