Efficacy of Oral Famciclovir Versus Aciclovir Treatment in Patients With Herpes Zoster

EMS177 enrolled

Overview

Herpes Zoster is an infection that affects part of the nervous system caused by Varicella Zoster Virus. Herpes Zoster manifests as vesicular eruption in the dermatome, often associated with significant pain. There are effective oral prescription antiviral medicines available to reduce the discomfort of symptoms as famciclovir and aciclovir. This is a phase III, multicenter, randomized, parallel-group study to compare the efficacy and safety of treatment with Famciclovir (500 mg) comparing to Aciclovir (400 mg) in patients with Herpes Zoster.

Study Design * single blind study, prospective, parallel group, intent to treat trial * Experiment duration: 7 days * 2 visits (days 0, and 7) * Reduction of symptoms * Adverse events evaluation

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

177

Conditions

Herpes Zoster

Interventions

FamciclovirDRUG

Famciclovir 500 mg- 1 tablet each 12 hours for 7 days

AciclovirDRUG

Aciclovir 400 mg- 02 tablets each 4 hours for 7 days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients must be able to understand the study procedures, agree to participate and give written consent. * Patients with clinical diagnosis of Herpes Zoster; * Score higher than 4 for at least for 2 symptoms of Herpes Zoster; * Negative pregnant urine test Exclusion Criteria: * Pregnancy or risk of pregnancy. * Lactation * Any pathology or past medical condition that can interfere with this protocol. * Non-steroidal anti-inflammatory drug , hormonal anti-inflammatory or immunosuppressive drugs (in the last 30 days and during the study); * Patients with immunodeficiency and/or immunosuppressive disease; * Hypersensitivity to components of the formula; * Other conditions deemed reasonable by the medical investigator as to the disqualification of the individual from study participation.

Locations (5)

Centro de Medicina Reprodutiva Dr Carlos Isaia Filho

Porto Alegre, Rio Grande do Sul, Brazil

Loema

Campinas, São Paulo, Brazil

Allergisa

Campinas, São Paulo, Brazil

CECIP Centro de Estudos Clínicos do Interior Paulista

Jaú, São Paulo, Brazil

Outcomes

Primary Outcomes

For efficacy evaluation, a visual analogue scale (VAS) will be used to detect the improvement of symptoms

Symptoms evaluated: pain, injury, loss of sensation, burning and itching

Time frame: day 7

Secondary Outcomes

Safety will be evaluated by the adverse events occurrences

Adverse events will be collected and followed in order to evaluate safety and tolerability

Time frame: day 7

Data from ClinicalTrials.gov

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