Lugoff, SCNCT04792034Now EnrollingIRB Ready

ENT Disorder Clinical Trial in Lugoff, SC

Access cutting-edge ent disorder treatment through this phase 3 clinical trial at a research site in Lugoff. Study-provided care at no cost to qualified participants.

Sponsored by Noden Pharma

Quick Self-Assessment

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Preparing your pre-screening questions…

Expert Care in Lugoff

Access ent disorder specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related ent disorder treatment provided free

Apply for This Lugoff Location

Check if you qualify for this ent disorder clinical trial in Lugoff, SC

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Lugoff

    Convenient for SC residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Lugoff site if eligible
  4. 4Begin participation

About This ENT Disorder Study in Lugoff

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.

Sponsor: Noden Pharma

Who Can Participate

Inclusion Criteria

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.
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.

Exclusion Criteria

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.
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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Lugoff?

Yes, this clinical trial (NCT04792034) has an active research site in Lugoff, SC that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

ENT Disorder Treatment Options in Lugoff, SC

If you're searching for ent disorder treatment options in Lugoff, SC, this clinical trial (NCT04792034) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Lugoff research site is actively enrolling participants for this phase 3 clinical trial. You'll receive care from experienced ent disorder specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all ent disorder clinical trials near you to find additional studies recruiting in your area.

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