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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

237 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2017-11-30

Brief Summary

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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).

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Detailed Description

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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

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Shingles Herpes Zoster Postherpetic Neuralgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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FV-100 400 mg QD

FV-100 400mg QD

Group Type EXPERIMENTAL

FV-100

Intervention Type DRUG

antiviral nucleoside analog

FV-100 400mg BID

FV-100 400mg BID(total daily dose of 800mg)

Group Type EXPERIMENTAL

FV-100

Intervention Type DRUG

antiviral nucleoside analog

valacyclovir

valacyclovir 1000mg TID

Group Type ACTIVE_COMPARATOR

valacyclovir

Intervention Type DRUG

antiviral nucleoside analog

Interventions

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FV-100

antiviral nucleoside analog

Intervention Type DRUG

valacyclovir

antiviral nucleoside analog

Intervention Type DRUG

Other Intervention Names

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antiviral nucleoside analog valtrex

Eligibility Criteria

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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