Randomized, prospective, multi-center, double blind placebo-controlled parallel group study of a Placebo Topical Solution versus Cocaine HCl 4% Topical Solution for safety and efficacy, and Cocaine HCl 4% and 10% Topical Solution for Safety as an anesthetic prior to a diagnostic procedure or surgery on or through accessible mucous membranes of the nasal cavities. Both domestic (United States) and foreign sites are eligible, and both inpatient and outpatient settings are eligible.
Eligible subjects will undergo either an office-based or operating room-based procedure or surgery. The approximately 620 subjects will be randomized in a 2:2:1 fashion to one of the three treatment groups (248 subjects randomized to the Cocaine HCl 4% solution, 248 subjects randomized to the Cocaine HCl 10%, and 124 subjects randomized to the placebo solution) pre-procedure and given one application of the assigned test product with Von Frey filament testing occurring after application.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
646
Topical solution, up to 4 mL, is applied for 20 minutes via cotton or rayon pledget(s) to the accessible mucous membranes of the nasal cavities.
Topical solution, up to 4 mL, is applied for 20 minutes via cotton or rayon pledget(s) to the accessible mucous membranes of the nasal cavities.
Topical solution, up to 4 mL, is applied for 20 minutes via cotton or rayon pledget(s) to the accessible mucous membranes of the nasal cavities.
Richmond ENT
Richmond, Virginia, United States
Immediate and Sustained Anesthetic Success for Cocaine HCl 4% Topical Solution and Placebo Topical Solution
Subjects who meet the following for each nostril that received the study drug application are considered a treatment success: Prior to the diagnostic procedure or surgery, based on the von Frey monofilament test, after application of the assigned study drug solution (Cocaine HCl 4% Topical Solution or Placebo Topical Solution), the subject response is a 0 (zero) pain score on the 11 point pain scale (0 = no pain, 10 = unbearable pain) compared to the von Frey monofilament test right before study drug application. And, during the diagnostic procedure or surgery, no further analgesic treatment is required (only 4% Cocaine HCl subjects who receive a diagnostic procedure or surgery). Subjects with missing primary outcome data are marked as treatment failures in both treatment groups.
Time frame: One Day, Single office based diagnostic procedure or surgery
Immediate and Sustained Anesthetic Success for Cocaine HCl 10% Topical Solution
Subjects who meet the following for each nostril that received the study drug application are considered a treatment success: Prior to the diagnostic procedure or surgery, based on the von Frey monofilament test, after application of the assigned study drug solution (Cocaine HCl 10% Topical Solution), the subject response is a 0 (zero) pain score on the 11 point pain scale (0 = no pain, 10 = unbearable pain) compared to the von Frey monofilament test right before study drug application. And, during the diagnostic procedure or surgery, no further analgesic treatment is required (only 10% Cocaine HCl subjects who receive a diagnostic procedure or surgery).
Time frame: One Day, Single office based diagnostic procedure or surgery
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