MedDataX Logo

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

NCT ID: NCT02412917

Last Updated: 2017-12-22

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

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

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Shingles Herpes Zoster Postherpetic Neuralgia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

FV-100

antiviral nucleoside analog

Intervention Type DRUG

valacyclovir

antiviral nucleoside analog

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

antiviral nucleoside analog valtrex

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

ContraVir Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

John Sullivan-Bolyai

Role: STUDY_DIRECTOR

CMO

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

TX

Webster, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CTRV-FV-2-007

Identifier Type: -

Identifier Source: org_study_id