drugset / Trial / NCT02500836

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

NCT02500836

Phase 3 Completed 646 enrolled Lannett Company, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2015-09
Primary completion
2016-07
Completion
2016-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Cocaine Small molecule 4 % Topical
Subject Cocaine Small molecule 10 % Topical

Indications