drugset

drugset / Trial / NCT00477334

Patient-initiated Episodic Treatment of Recurrent Genital Herpes in Black Patients

NCT00477334 ↗

Phase 4 Completed 463 enrolled Novartis

RandomizedParallel-groupDouble-blindTreatment

Summary

This study will evaluate the safety and efficacy of single-day famciclovir episodic treatment in Black patients with recurrent genital herpes

Timeline

Start: 2007-06
Primary completion: 2009-03
Completion: 2009-03

Outcome

Missed primary endpoint

registry Famciclovir 1000 mg vs Placebo Comparator; p = 0.4161; Median Difference (Final Values) 0.26 (95% CI -0.40 to 0.98) NCT00477334 ↗

Publications

Leone P, Abudalu M, Mitha E, Gani M, Zhou W, Hamed K. One-day famciclovir vs. placebo in patient-initiated episodic treatment of recurrent genital herpes in immunocompetent Black patients. Curr Med Res Opin. 2010 Mar;26(3):653-61. doi: 10.1185/03007990903554471.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Famciclovir	Small molecule	1000 mg	Oral

Indications