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A Study of FV-100 Versus Valacyclovir in Patients With Herpes Zoster

NCT00900783 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2015-10-12

No results posted yet for this study

Summary

The purpose of this study is to compare the safety and efficacy of two doses of FV-100 to valacyclovir in patients with herpes zoster, or shingles. FV-100 has shown to be very potent in cells infected with varicella zoster virus, the virus that causes shingles. The study objectives include:

* Compare the safety of FV-100 to valacyclovir
* Compare the effect of FV-100, as compared to valacyclovir, on shingles pain
* Compare the effect of FV-100, as compared to valacyclovir, on shingles lesions

Conditions

  • Herpes Zoster
  • Shingles

Interventions

DRUG

valacyclovir

1 gram, three times a day for seven days

DRUG

FV-100

400 mg, once daily, for seven days

DRUG

FV-100

200 mg, once daily, for seven days

DRUG

Valacyclovir placebo

three times a day, for seven days

DRUG

FV-100 placebo

once daily, for seven days

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2010-11-30
Completion
2010-12-31

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00900783 on ClinicalTrials.gov