NCT02500836

Topical Application of Cocaine HCl 4%, or 10%, or Placebo Solution in Local (Topical) Anesthesia

Phase III Topical Application of Cocaine HCl 4% Solution on Safety/Efficacy & Cocaine HCl 4% & 10% Solution on Safety in Local Anesthesia for Diagnostic Procedures & Surgeries on or Through Accessible Mucous Membranes of the Nasal Cavities

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 646 (actual)
• Sponsor: Lannett Company, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
DRUG	Cocaine HCl 4% Topical Solution	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.
DRUG	Cocaine HCl 10% Topical Solution	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.
DRUG	Placebo Topical Solution	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.

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2015-07-17
• Last updated: 2017-05-16
• Results posted: 2017-05-16

Locations

1 site across 1 country: United States