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

Study Overview
=================
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

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

Conditions
-----------------
Herpes Zoster

Intervention / Treatment
-----------------
* Drug: Famciclovir
* Drug: Aciclovir


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Famciclovir 500mg<br>1 tablet each 8 hours for 7 days | Drug: Famciclovir<br>* Famciclovir 500 mg- 1 tablet each 12 hours for 7 days<br>|
| Active Comparator: Aciclovir 400mg<br>2 tablets of Aciclovir 400 mg each 4 hours for 7 days | Drug: Aciclovir<br>* Aciclovir 400 mg- 02 tablets each 4 hours for 7 days<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | day 7 | 

Secondary Outcome Measures

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