Diagnostic Clinical Trial
Official title:
A Phase III Investigation of 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.
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.
Randomized, prospective, multisite, double-blind, placebo-controlled, parallel-group study
of a Placebo Topical Solution versus Cocaine HCl 4% or 10% Topical Solution as an anesthetic
prior to a diagnostic procedure or surgery.
In the Safety and Efficacy first phase, subjects will be randomized in a 1:1:1 fashion to
one of the three treatment groups (placebo, Cocaine HCl 4% or 10% topical solution)
pre-procedure and given one application of up to 4 mL from one bottle of the assigned test
product. After pre-procedure Von Frey filament testing, the blind will be broken, but only
relative to placebo versus cocaine, not relative to the strength of the cocaine. The placebo
subjects will then exit participation in the efficacy portion of the trial, and be followed
for safety for 7 days. Treatment group subjects who do not feel pain after Von Frey testing
will receive their surgery or diagnostic procedure and also be followed for safety for 7
days.
In the Safety second phase, subjects will be randomized in a 1:1 fashion to one of the two
treatment groups (Cocaine HCl 4% or 10% topical solution) pre-procedure and given one
application of up to one 4 mL of the assigned test product. After pre-procedure Von Frey
filament testing reveals a pain score of 0, subjects will receive their surgery or
diagnostic procedure, and then all subjects will be followed for safety for 7 days.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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