Clinical trial NCT02500836
Conditions: Any Ear Nose or Throat Conditions With Identified Need for a Diagnostic Procedure or Surgery on or Through the Mucous Membranes of the Nasal Cavities
Keywords: Ear Nose Throat
Sponsor: Lannett Company, Inc.
Start date: 2015-09-01; Completion date: 2016-07-01
Enrollment: 646 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
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.

Detailed description:
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.

Arms: arm 1: Cocaine HCl 4% Topical Solution, up to 4 mL, is applied for 20 minutes via cotton or rayon pledget(s), then the nasal site is tested with a Von Frey (or equivalent) filament (Size 5.88, about 60 grams of force) to determine and record whether the subject has a pain score of 0 (zero) (0 = No Pain, 10 = Unbearable pain) after treatment application compared to the Von Frey filament test right before treatment application. If a pain score of 0 (zero) is recorded, then the diagnostic procedure or surgery proceeds along with safety monitoring for at least 90 minutes after removal of the pledget(s). The subject will be followed for safety for seven days. The total number of pledgets used, and the amount of Cocaine HCl 4% topical solution used (1 mL per pledget) will be recorded. arm 2: Cocaine HCl 10% Topical Solution, up to 4 mL, is applied for 20 minutes via cotton or rayon pledget(s), then the nasal site is tested with a Von Frey (or equivalent) filament (Size 5.88, about 60 grams of force) to determine and record whether the subject has a pain score of 0 (zero) (0 = No Pain, 10 = Unbearable pain) after treatment application compared to the Von Frey filament test right before treatment application. If a pain score of 0 (zero) is recorded the application then proceed with the diagnostic procedure or surgery along with safety monitoring for at least 90 minutes post removal of pledgets, and, the subject will be followed for safety for at least seven days post solution application. The total number of pledgets used, and the amount of Cocaine HCl 10% topical solution used (1 mL per pledget) will be recorded. arm 3: Placebo Topical Solution, up to 4 mL, is applied for 20 minutes via cotton or rayon pledget(s), then the nasal site is tested with a Von Frey (or equivalent) filament (Size 5.88, about 60 grams of force) to determine and record whether the subject has a pain score of 0 (zero) (0 = No Pain, 10 = Unbearable pain) after treatment application compared to the Von Frey filament test right before treatment application. The subject will then exit the treatment portion of the trial and be followed for safety for seven days . The total number of pledgets used, and the amount of placebo solution used (1 mL per pledget) will be recorded. After a minimum of 90 minutes from the time of study drug pledget removal, the subjects may have their surgery or diagnostic procedure, and the treatment reverts to standard anesthetic management (e.g. application of lidocaine, tetracaine, bupivicaine or other suitable products at the discretion of the investigator).
Interventions: intervention 1: Cocaine HCl 4% Topical Solution intervention 2: Cocaine HCl 10% Topical Solution intervention 3: Placebo Topical Solution
Intervention descriptions: intervention 1: 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. intervention 2: 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. intervention 3: 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.

Protocol documents: