Expired Study
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Webster, Texas 77598


Purpose:

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).


Study 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). 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.


Criteria:

Inclusion Criteria: - Receive a clinical diagnosis of uncomplicated AHZ as evidenced by a unilateral dermatomal rash - Have zoster-related pain - Are able to be randomized and receive their first dose within approximately 120 hours from appearance of rash Exclusion Criteria: - Have multidermal or disseminated AHZ - Have facial, ophthalmologic or oral manifestations - Have received Zostavax


NCT ID:

NCT02412917


Primary Contact:

Study Director
John Sullivan-Bolyai
CMO


Backup Contact:

N/A


Location Contact:

Webster, Texas 77598
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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