ENT DisorderPhase 3NCT04792034
Pharmacokinetics, Safety, and Tolerability Study of GOPRELTO® Nasal Solution and NUMBRINO™ Nasal Solution
A Phase 3 study testing Cocaine Hydrochloride Nasal Solution in people with ENT Disorder and Nasal Procedures, run by LXO Ireland at 6 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- ENT Disorder, Nasal Procedures, Nasal Anesthesia
- What is being tested?
- Cocaine Hydrochloride Nasal Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 6 sitesUnited States
- Study dates
- 6 Dec 2025to 31 Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- A subject will be eligible for inclusion in the study if he or she meets all of the following criteria:
- Is accompanied and/or represented by a parent or guardian able to comprehend and sign the informed consent document.
- Is able to understand and provide assent to an age-appropriate subject assent form (as defined by local practice or regulation).
- Subject or parent/guardian is able to communicate with the Investigator and comply with the requirements of the protocol.
- Is male or female ≥12 to <18 years of age at the time of dosing.
- Is no lower than the 10th percentile for weight according to age.
Show all 10Show fewer
- Has a body mass index (BMI) no lower than the 5th percentile by age.
- Has an oxygen saturation of at least 98%.
- Will be undergoing a diagnostic procedure or surgery on or through the nasal mucous membranes of either one or both nostrils.
- 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.
Who cannot join
- A subject will be excluded from the study if he or she meets any of the following criteria:
- Has a history of seizure.
- 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).
- Has previously received intranasal topical cocaine within 14 days prior to the Screening Visit.
- Has participated in an investigational study or received an investigational drug within 30 days preceding Treatment Day 1.
- Has a history of abuse of controlled substances, nasal or otherwise.
Show all 22Show fewer
- 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.
- Is a pregnant female or nursing mother or has a positive urine pregnancy test at the Screening Visit or on Treatment Day 1.
- 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.
- 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.
- 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.
- Use of disulfiram.
- Planned or anticipated need for additional vasoconstrictor agents such as epinephrine or phenylephrine.
- 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.
- 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.
- 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.
- 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.
- Has a known personal or family history of hereditary pseudocholinesterase deficiency.
- 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).
- Has any laboratory result outside the normal laboratory reference range deemed clinically significant by the Investigator.
- Has a history of, or current, hepatic or renal disease.
- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 2 recruiting
- Recruiting
SCENT Ambulatory Surgical Center, 145 Park Central Dr, Suite 200
Columbia, South Carolina, 29203
Wayne Joseph Harsha, M.D, 803-630-5353, entdoc@carolinapinesent.com
- Completed
SCENT Sleep and Allergy, 110 Highland Center Drive
Columbia, South Carolina, 29203
- Completed
SCENT Sleep and Allergy, 145 Park Central
Columbia, South Carolina, 29203
- Completed
South Carolina ENT, Sleep and Allergy
Columbia, South Carolina, 29212
- Completed
SCENT Sleep and Allergy, 15 Exchange Dr.
Lugoff, South Carolina, 29078
- Recruiting
Carolina Pines Ear Nose Throat & Allergy Associates LLC, 2562 Kinard Street
Newberry, South Carolina, 29108
Wayne Joseph Harsha, M.D, 803-630-5353, entdoc@carolinapinesent.com
About this study
Official title: A Multicenter, 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
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.
Read the detailed description
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:
- To assess the safety and tolerability of GOPRELTO® and NUMBRINO™ nasal solution in pediatric adolescent subjects as an anesthetic for diagnostic procedures and surgeries on or through the mucous membranes of the nasal cavities, respectively.
- To evaluate the PK properties and define the dosing for GOPRELTO® and NUMBRINO™ nasal solution, respectively, in pediatric adolescent subjects as an anesthetic for diagnostic procedures and surgeries on or through the mucous membranes of the nasal cavities.
- Conditions
- ENT Disorder, Nasal Procedures, Nasal Anesthesia, Nasal Mucosa Surgery
- Being tested
- Cocaine Hydrochloride Nasal Solution
- Keywords
- Nasal, Sinus, ENT
- Medical subject headings
- Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cocaine Hydrochloride Nasal SolutionDrug
Also called GOPRELTO®
Topical Anesthetic
Cocaine Hydrochloride Nasal SolutionDrug
Also called NUMBRINO™
Topical Anesthetic
| Study group | Role | What they receive |
|---|---|---|
| GOPRELTO® nasal solution, 4%, | Experimental | 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 Receives: Drug: Cocaine Hydrochloride Nasal Solution |
| NUMBRINO™ nasal solution, 4% | Experimental | 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 Receives: Drug: Cocaine Hydrochloride Nasal Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Screening Visit
Electrocardiogram
Any changes or delays in heart rhythm while on medication. Electrocardiogram will be performed in the supine position.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (pre-dose), 20, 40, 60, and 90 minutes, and 2, 4, and 8 hours after pledget application.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start6 Dec 2025
- Primary completionDec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ENT DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Open-label, single-dose, non-randomized, two-arm sequential, multicenter study
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LXO Ireland
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Omnivium Pharmaceuticals LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04792034
- Sponsor's protocol ID
- RA-VP-000-357
- Status last verified
- Oct 2026
- First submitted
- 22 Feb 2021
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, 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
- ClinicalTrials.gov ID
- NCT04792034
- Acronym / sponsor ID
- RA-VP-000-357
- Conditions
- ENT Disorder, Nasal Procedures, Nasal Anesthesia, Nasal Mucosa Surgery
- Keywords
- Nasal, Sinus, ENT
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- LXO IrelandIndustry (pharma, biotech, devices)
- Collaborators
- Omnivium Pharmaceuticals LLC
- Study start
- 6 Dec 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 10 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- To assess the safety and tolerability of GOPRELTO® and NUMBRINO™ nasal solution in pediatric adolescent subjects as an anesthetic for diagnostic procedures and surgeries on or through the mucous membranes of the nasal cavities, respectively.
- To evaluate the PK properties and define the dosing for GOPRELTO® and NUMBRINO™ nasal solution, respectively, in pediatric adolescent subjects as an anesthetic for diagnostic procedures and surgeries on or through the mucous membranes of the nasal cavities.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-label, single-dose, non-randomized, two-arm sequential, multicenter study
| Arm | Type | Receives |
|---|---|---|
| GOPRELTO® nasal solution, 4%, | Experimental | Drug: Cocaine Hydrochloride Nasal SolutionFDA 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 |
| NUMBRINO™ nasal solution, 4% | Experimental | Drug: Cocaine Hydrochloride Nasal SolutionFDA 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 |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- A subject will be eligible for inclusion in the study if he or she meets all of the following criteria:
- Is accompanied and/or represented by a parent or guardian able to comprehend and sign the informed consent document.
- Is able to understand and provide assent to an age-appropriate subject assent form (as defined by local practice or regulation).
- Subject or parent/guardian is able to communicate with the Investigator and comply with the requirements of the protocol.
- Is male or female ≥12 to <18 years of age at the time of dosing.
Key exclusion criteria (22 listed)
- A subject will be excluded from the study if he or she meets any of the following criteria:
- Has a history of seizure.
- 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).
- Has previously received intranasal topical cocaine within 14 days prior to the Screening Visit.
- Has participated in an investigational study or received an investigational drug within 30 days preceding Treatment Day 1.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cocaine Hydrochloride Nasal SolutionAlso: GOPRELTO®Topical Anesthetic | Drug | GOPRELTO® nasal solution, 4%, |
| Cocaine Hydrochloride Nasal SolutionAlso: NUMBRINO™Topical Anesthetic | Drug | NUMBRINO™ nasal solution, 4% |
Primary outcome
Changes in Blood pressure
Time frame: Baseline and every 5 minutes through 90 minutes post-pledget application.
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.
Changes in Heart rate
Time frame: Baseline and every 5 minutes through 90 minutes post-pledget application.
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.
Changes in Respiratory Rate
Time frame: Baseline and every 5 minutes through 90 minutes post-pledget application.
Any changes in respiratory rate (increase or decrease) while on study medication.
Physical examination
Time frame: Screening Visit
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.
Electrocardiogram
Time frame: Screening Visit, and on Day 1 at Baseline (pre-dose), continuously during treatment, and through 90 minutes post-pledget application
Any changes or delays in heart rhythm while on medication. Electrocardiogram will be performed in the supine position.
Pulse Oximetry
Time frame: Screening Visit, and on Day 1 at Baseline (pre-dose), every 5 minutes during treatment, and through 90 minutes post-pledget application
Any changes in the amount of oxygen in the blood while on study medication.
Incidence of Adverse events (AEs)
Time frame: From Day 1 (pledget application) through the final follow-up call at Day 10.
The number and percentage of subjects with AEs, AEs severity, causality, Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs).
Maximum observed plasma concentration (Cmax)
Time frame: Screening Visit, Baseline (pre-dose), 20, 40, 60, and 90 minutes, and 2, 4, and 8 hours after pledget application.
Measurement of the amount of the study medication (cocaine topical solution) in the blood over 8 hours to define the Cmax.
Time to maximum observed plasma concentration (Tmax)
Time frame: Screening Visit, Baseline (pre-dose), 20, 40, 60, and 90 minutes, and 2, 4, and 8 hours after pledget application.
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.
Area under the plasma concentration versus time curve from time of dosing (0) to the time of last quantifiable concentration (AUClast)
Time frame: Screening Visit, Baseline (pre-dose), 20, 40, 60, and 90 minutes, and 2, 4, and 8 hours after pledget application.
Measurement of the amount of the study medication (cocaine topical solution) in the blood over 8 hours to define the AUC.
Area under the plasma concentration versus time curve from time of dosing (0) to infinity (AUCinf)
Time frame: Screening Visit, Baseline (pre-dose), 20, 40, 60, and 90 minutes, and 2, 4, and 8 hours after pledget application.
Measurement of the total exposure to the study medication in the blood over 8 hours, starting from dosing and extrapolated to infinity.
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)]
Time frame: Screening Visit, Baseline (pre-dose), 20, 40, 60, and 90 minutes, and 2, 4, and 8 hours after pledget application.
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.
Terminal half-life in plasma calculated from the kel as ln(2)/kel (t½)
Time frame: Baseline (pre-dose), 20, 40, 60, and 90 minutes, and 2, 4, and 8 hours after pledget application.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cocaine Hydrochloride Nasal Solution in people with ENT Disorder and Nasal Procedures, run by LXO Ireland at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Robert Puchlaski, M.D (803-256-7076; 803-549-2467, rpuchalski@me.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Blood pressure (time frame: Baseline and every 5 minutes through 90 minutes post-pledget application.). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.