CompletedPhase 3

Topical Anesthetic for Procedures Through the Nose

United States648 participantsStarted 2014-09

Plain-language summary

To determine if RX0041-002 is a safe and effective topical anesthetic.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Is able to understand and comply with protocol requirements, provide written informed consent and HIPPA authorization. Residents of California must also review and sign the California Subject Bill of Rights.
. Is male or female ≥18 years of age, inclusive, at the time of dosing.
. Has a predetermined need from a physician for a diagnostic procedure or surgery on or through the nasal mucous membranes of either one or both nostrils.
. Has the ability to feel pain sensation normally in the anterior nasal septum, as verified by Von Frey 6.10 filament testing.
. Has the ability to clearly communicate pain and sensation of the anterior nasal septum.
. Females (if of child-bearing potential and sexually active) and males (if sexually active with a partner of child-bearing potential) who agree to use a medically acceptable and effective birth control method from the first dose and for 8 days following last dose of study drug. Medically acceptable methods of contraception that may be used by the participant and/or his/her partner include abstinence, birth control pills or patches, diaphragm, intrauterine device (IUD), condom, surgical sterilization, and progestin implant or injection. Prohibited methods include: the rhythm method or withdrawal.

Exclusion criteria

. Has a known allergy to any ester based anesthetics including cocaine HCl, 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 anesthetic allergies are NOT exclusionary. Amide based anesthetics are: Lidocaine, Mepivicaine, Bupivicaine, Levobupivicaine, Ropivicaine, Etidocaine, Prilocaine, and Articaine).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Anesthetized mucous membrane measured using a Von Frey Pain Measure Device

Timeframe: 20 minutes

Trial details

NCT IDNCT02667054

SponsorPharmaceutical Project Solutions, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-12

View on ClinicalTrials.gov More Drug Reaction to Analgesic Nos trials