NCT00900783

A Study of FV-100 Versus Valacyclovir in Patients With Herpes Zoster

A Phase II, Multicenter, Randomized, Double-Blind, Parallel-Group, Comparative Study of FV-100 vs. Valacyclovir in Patients With Herpes Zoster

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 350 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the safety and efficacy of two doses of FV-100 to valacyclovir in patients with herpes zoster, or shingles. FV-100 has shown to be very potent in cells infected with varicella zoster virus, the virus that causes shingles. The study objectives include: * Compare the safety of FV-100 to valacyclovir * Compare the effect of FV-100, as compared to valacyclovir, on shingles pain * Compare the effect of FV-100, as compared to valacyclovir, on shingles lesions

Conditions

• Herpes Zoster
• Shingles

Interventions

Type	Name	Description
DRUG	valacyclovir	1 gram, three times a day for seven days
DRUG	FV-100	400 mg, once daily, for seven days
DRUG	FV-100	200 mg, once daily, for seven days
DRUG	Valacyclovir placebo	three times a day, for seven days
DRUG	FV-100 placebo	once daily, for seven days

Timeline

• Start date: 2009-05-01
• Primary completion: 2010-11-01
• Completion: 2010-12-01
• First posted: 2009-05-13
• Last updated: 2015-10-12