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

NCT02500836 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 646

Last updated 2017-05-16

Study results available
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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.

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

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.

Sponsors & Collaborators

  • Lannett Company, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2016-07-31
Completion
2016-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02500836 on ClinicalTrials.gov