NCT02412917

A Comparative Study of FV-100 vs. Valacyclovir for the Prevention of Post-Herpetic Neuralgia

A Multicenter, Randomized, Double-Blind, Parallel-Group, Comparative Study of FV-100 vs. Valacyclovir for the Prevention of Post-Herpetic Neuralgia and Treatment of Acute Herpes Zoster Associated Pain

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 237 (actual)
• Sponsor: ContraVir Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, double-blind, parallel-group, active controlled comparative study of the safety and efficacy of 2 dosing regimens of FV-100 versus valacyclovir administered for 7 days in subjects with uncomplicated AHZ(acute herpes zoster).

Detailed description

This is a multicenter, randomized, double-blind, parallel-group, active controlled comparative study of the safety and efficacy of 2 dosing regimens of FV-100 versus valacyclovir administered for 7 days in subjects with uncomplicated AHZ(acute herpes zoster). Subjects diagnosed with uncomplicated AHZ within 72 hours of lesion appearance and worst pain of 4 or greater at day 1, will be randomized (1:1:1) to one of three treatment groups and will begin study treatment at the Day 1 visit(within 72 hours of AHZ lesion appearance) to either: 1. FV-100 400mg QD, 2. FV-100 400mg BID(total daily dose of 800mg), or 3. Valacyclovir 1000mg 3 times a day for a total daily dose of 3000mg. Subjects will be monitored for adverse events through day 21. Efficacy assessments for lesion status and AHZ pain are captured til day 120.

Conditions

• Shingles
• Herpes Zoster
• Postherpetic Neuralgia

Interventions

Type	Name	Description
DRUG	FV-100	antiviral nucleoside analog
DRUG	valacyclovir	antiviral nucleoside analog

Timeline

• Start date: 2015-06-01
• Primary completion: 2017-11-01
• Completion: 2017-11-01
• First posted: 2015-04-09
• Last updated: 2017-12-22

Locations

1 site across 1 country: United States