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

Phase 3

Completed

• Conditions: Herpes Zoster
• Interventions: Drug: Famciclovir; Drug: Aciclovir

• Registration Number: NCT01327144
• Lead Sponsor: EMS

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

Study Timeline

• Study First Submitted: 2011-03-30
• Study First Submitted QC: 2011-03-31
• Study First Posted: 2011-04-01
• Study Start: 2012-06
• Primary Completion: 2017-05
• Study Completion: 2017-07
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-15
• Last Update Posted: 2019-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 177

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Famciclovir 500mg	Famciclovir	1 tablet each 8 hours for 7 days
Aciclovir 400mg	Aciclovir	2 tablets of Aciclovir 400 mg each 4 hours for 7 days

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (5)

Allergisa; 🇧🇷 Campinas, São Paulo, Brazil

Centro de Medicina Reprodutiva Dr Carlos Isaia Filho; 🇧🇷 Porto Alegre, RS, Brazil

Loema; 🇧🇷 Campinas, SP, Brazil

CECIP Centro de Estudos Clínicos do Interior Paulista; 🇧🇷 Jau, SP, Brazil

Afip - Associacao Fundo de Incentivo A Pesquisa; 🇧🇷 Sao Paulo, SP, Brazil