Investigation of topical intranasal cocaine for sinonasal procedures: a randomized, phase III clinical trial
Autor: | Alexa Noel McGrath, Jason E. Cohn, Jacob Burdett, John McGrath, Tom Shokri |
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Rok vydání: | 2020 |
Předmět: |
Vital signs
Pain Placebo law.invention 03 medical and health sciences 0302 clinical medicine Cocaine Double-Blind Method Randomized controlled trial law Humans Immunology and Allergy Medicine Prospective Studies 030223 otorhinolaryngology Adverse effect Administration Intranasal business.industry United States Clinical trial Exact test Blood pressure 030228 respiratory system Otorhinolaryngology Anesthesia Nasal administration business |
Zdroj: | International Forum of Allergy & Rhinology. 10:981-990 |
ISSN: | 2042-6984 2042-6976 |
Popis: | Background The objective of this trial was to demonstrate the clinical efficacy and safety of topical cocaine as part of the effort to gain regulatory approval from the United States Food and Drug Administration. Methods This phase III, randomized, prospective, double-blind, multicenter, single-dose, placebo- and dose-controlled, parallel-group study aimed to evaluate the safety and efficacy of topical intranasal cocaine (RX0041-002). A total of 925 subjects were screened and a total of 648 subjects were randomized: 95 to placebo; 275 to 4% RX0041-002; and 278 to 8% RX0041-002. Efficacy was assessed with subjective pain intensity scores using the visual numeric rating scale and objectively using the von Frey filament test. Adverse events (AEs), vital signs, Holter monitoring, nasal irritation on visual examination, and smell assessment were recorded. The placebo and experimental groups were compared using a two-tailed Fisher's exact test. Results Topical 4% and 8% cocaine achieved significant subject analgesia, the primary efficacy endpoint. Both doses were safe and well-tolerated, with a safety profile similar to placebo. In the 4% and 8% groups, headache (1.5% and 2.5%, respectively), epistaxis (0.7% and 1.1%), and anxiety (0.7% and 0%) were the only AEs reported by >1 subject. No cardiovascular AEs, serious AEs, or deaths occurred. A higher percentage of subjects in the 4% and 8% groups compared with the placebo group had a modest increase in either systolic or diastolic blood pressure. Conclusion Topical 4% and 8% cocaine is an effective anesthetic that can be safely administered for nasal procedures. |
Databáze: | OpenAIRE |
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