Topical Application of Cocaine HCl 4%, or 10%, or Placebo Solution in Local (Topical) Anesthesia
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
Outcome
Met primary endpoint
registry NUMBER Cocaine HCI 4% Topical Solution: 0.7093 (0.6498 to 0.7640) proportion of participants NCT02500836 ↗
registry analysis (superiority test); Cocaine HCI 4% Topical Solution vs Placebo Topical Solution; p <0.0001; Fisher Exact; note: One-sided p-value NCT02500836 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cocaine | Small molecule | 4 % | Topical |
| Subject | Cocaine | Small molecule | 10 % | Topical |