Clinical trial NCT01746940
Conditions: Diagnostic Procedures and Surgeries on or Through Accessible Mucous Membranes of the Nasal Cavities
Keywords: Surgery Surgeries Nasal Cavities Diagnosis Diagnostic Nose Rhinoplasty Endoscopy Bronchoscopy
Sponsor: Lannett Company, Inc.
Start date: 2014-03-01; Completion date: 2015-07-01
Enrollment: 159 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief 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.

Arms: arm 1: Group 1: Placebo group -Placebo solution, up to 4 mL, is applied for 20 minutes via cotton pledget(s), then the nasal site is tested with a Von Frey (or equivalent) filament (Size 5.18, about 15 grams of force) to determine and record pain on a pain scale of 0 to 10. The subject will then exit the treatment portion of the trial and be followed for safety for seven days . All placebo subjects, regardless of Von Frey filament test results, will undergo Phase 1 recovery (i.e. at least 90 minutes after cotton pledget removal) and associated required study procedures (including the final 12 lead ECG). After a minimum of 24 hours from the time of study drug pledget removal, the subject may continue the procedure, and the treatment reverts to standard anesthetic management (suitable products at the discretion of the investigator). Alternatively, at the investigator's discretion, the diagnostic procedure or surgery may be delayed until study termination. arm 2: Group 2: Cocaine HCI 4% Group - Cocaine HCl 4% topical solution, up to 4 mL, is applied for 20 minutes via cotton pledget(s), then the nasal site is tested with a Von Frey (or equivalent) filament (Size 5.18, about 15 grams of force) to determine and record pain on a pain scale of 0 to 10. If a score of 0 is recorded, then the diagnostic procedure or surgery proceeds along with safety monitoring for at least 90 minutes after removal of the pledget(s). The subject will be followed for safety for seven days. The total amount of Cocaine HCl 4% topical solution used will be recorded. arm 3: Group 3: Cocaine HCI 10% Group - Cocaine HCl 10% topical solution, up to 4 mL, is applied for 20 minutes via cotton pledget(s), then the nasal site is tested with a Von Frey (or equivalent) filament (Size 5.18, about 15 grams of force) to determine and record pain on a pain scale of 0 to 10. If a score of 0 is recorded the application then proceed with the diagnostic procedure or surgery along with safety monitoring for at least 90 minutes post removal of pledgets, and, the subject will be followed for safety for at least seven days post solution application. The total amount of Cocaine HCl 10% topical solution used will be recorded.
Interventions: intervention 1: Cocaine HCl 4% Topical Solution intervention 2: Cocaine HCl 10% Topical Solution intervention 3: Placebo Topical Solution
Intervention descriptions: intervention 1: Cocaine HCl 4% Topical Solution intervention 2: Cocaine HCl 10% Topical Solution intervention 3: Placebo Topical Solution

Protocol documents: