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

December 20, 2017 updated by: ContraVir Pharmaceuticals, Inc.

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

237

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FV-100 400 mg QD
FV-100 400mg QD
Drug: FV-100
antiviral nucleoside analog
Other Names:
  • antiviral nucleoside analog
Experimental: FV-100 400mg BID
FV-100 400mg BID(total daily dose of 800mg)
Drug: FV-100
antiviral nucleoside analog
Other Names:
  • antiviral nucleoside analog
Active Comparator: valacyclovir
valacyclovir 1000mg TID
Drug: valacyclovir
antiviral nucleoside analog
Other Names:
  • valtrex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
efficacy measure
Day 1 to Day 120

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute herpes zoster associated pain, as measured by Zoster Brief Pain Inventory(ZBPI)
Time Frame: Day 1 to Day 120
efficacy measure
Day 1 to Day 120
The effect on lesion formation and healing of 2 dose regimens of FV-100 compared to valacyclovir
Time Frame: Day 1 to Day 120
efficacy measure
Day 1 to Day 120
The number and classification of adverse events in 2 dosing regimens of FV-100
Time Frame: Day 1 to Day 120
Safety measure
Day 1 to Day 120
The pharmacokinetic profile of the active metabolite of FV-100 after 7 days of dosing at 400mg QD versus compared with 400mg BID
Time Frame: Day 1 to Day 120
Pharmacokinetic
Day 1 to Day 120

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ContraVir Pharmaceuticals, Inc.

Investigators

  • Study Director: John Sullivan-Bolyai, CMO

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

November 1, 2017

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

March 23, 2015

First Submitted That Met QC Criteria

April 6, 2015

First Posted (Estimate)

April 9, 2015

Study Record Updates

Last Update Posted (Actual)

December 22, 2017

Last Update Submitted That Met QC Criteria

December 20, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTRV-FV-2-007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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