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

Part of paid clinical trials in Webster, Texas.

Sponsor
ContraVir Pharmaceuticals, Inc.
Study ID
NCT02412917
Phase
PHASE3
Status
Terminated

Conditions

  • Herpes Zoster
  • Postherpetic Neuralgia
  • Shingles

Eligibility Criteria

Sex
ALL
Age
30 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • FV-100 — DRUG
    antiviral nucleoside analog
  • valacyclovir — DRUG
    antiviral nucleoside analog

Study Details

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).

Key Dates

Start date
Jun 30, 2015
Status verified
Dec 2017
Primary completion
Nov 30, 2017
Completion
Nov 30, 2017

Study Design

Enrollment
237 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: FV-100 400 mg QD
    FV-100 400mg QD
  • Experimental: FV-100 400mg BID
    FV-100 400mg BID(total daily dose of 800mg)
  • Active Comparator: valacyclovir
    valacyclovir 1000mg TID

Primary Outcome Measure

The incidence of post-herpetic neuralgia(PHN) following treatment with 2 dose regimens of FV-100 compared to valacyclovir. [ Time Frame: Day 1 to Day 120 ]

Locations (1)

FacilityCityStateZIPSite coordinators
TXWebsterTexas77598-

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