NCT01746940

Topical Application of Cocaine HCl 4% and 10% on Safety and Efficacy in Local (Topical) Anesthesia

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.

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 159 (actual)
• Sponsor: Lannett Company, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Diagnostic
• Procedures and Surgeries on or Through Accessible Mucous Membranes
• of the Nasal Cavities

Interventions

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

Timeline

• Start date: 2014-03-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2012-12-11
• Last updated: 2017-05-12
• Results posted: 2016-07-11

Locations

2 sites across 1 country: United States