Pharmacokinetics, Safety, and Tolerability Study of GOPRELTO® Nasal Solution and NUMBRINO™ Nasal Solution
NCT ID: NCT04792034
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
40 participants
INTERVENTIONAL
2025-12-06
2027-12-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
PREVENTION
NONE
Study Groups
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GOPRELTO® nasal solution, 4%,
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
Cocaine Hydrochloride Nasal Solution
Topical Anesthetic
NUMBRINO™ nasal solution, 4%
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
Cocaine Hydrochloride Nasal Solution
Topical Anesthetic
Interventions
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Cocaine Hydrochloride Nasal Solution
Topical Anesthetic
Cocaine Hydrochloride Nasal Solution
Topical Anesthetic
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
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.
12 Years
18 Years
ALL
No
Sponsors
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Omnivium Pharmaceuticals LLC
INDUSTRY
LXO Group
INDUSTRY
Noden Pharma
INDUSTRY
Responsible Party
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Locations
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SCENT Sleep and Allergy, 110 Highland Center Drive
Columbia, South Carolina, United States
SCENT Sleep and Allergy, 145 Park Central
Columbia, South Carolina, United States
South Carolina ENT, Sleep and Allergy
Columbia, South Carolina, United States
SCENT Sleep and Allergy, 15 Exchange Dr.
Lugoff, South Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Robert Puchlaski, M.D.
Role: primary
Robert Puchlaski, M.D.
Role: primary
Robert Puchlaski, M.D.
Role: primary
Robert Puchlaski, M.D.
Role: primary
Other Identifiers
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RA-VP-000-357
Identifier Type: -
Identifier Source: org_study_id