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

A Prospective, Randomized, Multicenter Study of the Efficacy and Safety of Famciclovir 500 mg Comparing To Aciclovir 400mg in Patients With Herpes Zoster

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01327144

Enrollment

177

Registered

2011-04-01

Start date

2012-06-30

Completion date

2017-07-31

Last updated

2019-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Herpes Zoster

Brief summary

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.

Detailed description

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

Interventions

DRUGFamciclovir

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

DRUGAciclovir

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
For efficacy evaluation, a visual analogue scale (VAS) will be used to detect the improvement of symptoms	day 7	Symptoms evaluated: pain, injury, loss of sensation, burning and itching

Secondary

Measure	Time frame	Description
Safety will be evaluated by the adverse events occurrences	day 7	Adverse events will be collected and followed in order to evaluate safety and tolerability

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026