At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 646 enrolled

Drug / intervention

Cocaine HCl 4% Topical Solution +2 moredrug

Likely dose

Cocaine HCl 4% Topical Solution 4 mLfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02500836

NCT02500836Phase 3Completed

Compare CT.gov

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

Lannett Company, Inc.·interventional·Posted Jul 17, 2015·Updated May 16, 2017

In Brief

A Phase 3 clinical trial evaluating Cocaine HCl 4% Topical Solution, Cocaine HCl 10% Topical Solution, and 1 other intervention for Any Ear Nose or Throat Conditions and With Identified Need for a Diagnostic Procedure or Surgery on or Through the Mucous Membranes of the Nasal Cavities. Completed, enrolled 646 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsAny Ear Nose or Throat Conditions, With Identified Need for a Diagnostic Procedure or Surgery on or Through the Mucous Membranes of the Nasal Cavities

CountriesUnited States

Collaborators--

Timeline

Phase 3CompletedFinished

20162017201820192020202120222023202420252026

First PostedJul 2015

Enrollment StartSep 2015

Primary CompletionJul 2016

TodayJul 2026

First PostedJul 17, 2015

Enrollment StartSep 1, 2015

Primary CompletionJul 1, 2016

TodayJul 2, 2026

Enrollment to primary: 10 monthsPosted 11.0 years ago

Interventions

Cocaine HCl 4% Topical Solutiondrug

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.

Cocaine HCl 10% Topical Solutiondrug

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.

Placebo Topical Solutiondrug

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.