Topical Application of Cocaine HCl 4% and 10% on Safety and Efficacy in Local (Topical) Anesthesia (NCT01746940) | Clinical Trial Compass
TerminatedPhase 3
Topical Application of Cocaine HCl 4% and 10% on Safety and Efficacy in Local (Topical) Anesthesia
Stopped: Trial operational issues.
United States159 participantsStarted 2014-03
Plain-language summary
This study aims to evaluate topical application of Cocaine HCl 4% and 10% on safety and efficacy in local (topical) anesthesia for diagnostic procedures and surgeries on or through accessible mucous membranes of the nasal cavities.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Provide written informed consent and HIPAA authorization. Residents of California must also review and sign the California Subject Bill of Rights.
* Male or female ≥18 years of age.
* Predetermined need from a physician for a diagnostic procedure or surgery of or through the nasal mucous membranes of either one or two nostrils.
* Ability to feel pain sensation normally in the nasal mucous membranes, as verified via Von Frey 5.18 monofilament testing.
* Ability to clearly communicate pain and sensation of the nasal mucous membranes.
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).
* Has a history of abuse of controlled substances, nasal or otherwise, or has damage to the nasal space that in the opinion of the investigator might interfere with the ability of the subject or the investigator to judge anesthesia from the trial drug.
* Has used any investigational drug(s) within 30 days preceding the randomization.
* Is pregnant or is a nursing mother
* Women of childbearing potential (WOCBP) and men must be using an acceptable method of contraception to avoid pregnancy thro…
What they're measuring
1
Immediate and Sustained Analgesic Success
Timeframe: Prior to and During a one-day Surgery or Diagnostic Procedure