Experimental Pain Study to Assess Local Anesthetic Efficacy and Safety of CTY-5339 Anesthetic Spray in Normal Volunteers

Summary

The purpose of this study is to determine if the topical application to cheek tissue of the combination of benzocaine and tetracaine has a longer duration of local anesthetic activity than benzocaine alone.

Timeline

Start

2016-12-07

Primary completion

2017-04-02

Completion

2017-06-07

Outcome

Missed primary endpoint

registry analysis (superiority test); One Spray CTY-5339-A vs One Spray CTY-5339-CB; p = 0.322; Mean Difference (Final Values) 2.8 (95% CI -3.06 to 8.69); ANOVA NCT02908620 ↗

registry analysis (superiority test); One Spray CTY-5339-A vs One Spray CTY-5339-CB; p = 0.134; Mean Difference (Final Values) -8.7 (95% CI -20.38 to 2.99); ANOVA NCT02908620 ↗

Publications

• Wang S, Giannakopoulos H, Lowstetter J, Kaye L, Lee C, Secreto S, Ho V, Hutcheson MC, Farrar JT, Wang P, Doyle G, Cooper SA, Hersh EV. Lack of Methemoglobin Elevations After Topical Applications of Benzocaine Alone or Benzocaine Plus Tetracaine to the Oral Mucosa. Clin Ther. 2017 Oct;39(10):2103-2108. doi: 10.1016/j.clinthera.2017.08.017. Epub 2017 Sep 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Benzocaine	Small molecule	28 mg	Topical
Subject	Benzocaine	Small molecule	56 mg	Topical
Subject	tetracaine	Other / unclassified	4 mg	Topical
Subject	tetracaine	Other / unclassified	8 mg	Topical

Indications

No indication recorded.