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

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 Overview

• Status: Completed
• Conditions: Herpes Zoster
• Intervention / Treatment: Drug: Famciclovir; Drug: Aciclovir

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 Type: Interventional
• Enrollment (Actual): 177
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • RS
    • Porto Alegre, RS, Brazil
      • Centro de Medicina Reprodutiva Dr Carlos Isaia Filho
  • SP
    • Campinas, SP, Brazil, 13010001
      • Loema
    • Jau, SP, Brazil
      • CECIP Centro de Estudos Clínicos do Interior Paulista
    • Sao Paulo, SP, Brazil
      • Afip - Associacao Fundo de Incentivo A Pesquisa
  • São Paulo
    • Campinas, São Paulo, Brazil
      • Allergisa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: EMS
• Investigators: Study Director: Joyce Silva, MD, EMS

Publications and helpful links

General Publications

• Pott Junior H, de Oliveira MFB, Gambero S, Amazonas RB. Randomized clinical trial of famciclovir or acyclovir for the treatment of herpes zoster in adults. Int J Infect Dis. 2018 Jul;72:11-15. doi: 10.1016/j.ijid.2018.04.4324. Epub 2018 May 7.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2012
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: March 30, 2011
• First Submitted That Met QC Criteria: March 31, 2011
• First Posted (Estimate): April 1, 2011

Study Record Updates

• Last Update Posted (Actual): April 17, 2019
• Last Update Submitted That Met QC Criteria: April 15, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; Infections; DNA Virus Infections; Skin Diseases, Infectious; Skin Diseases, Viral; Herpesviridae Infections; Varicella Zoster Virus Infection; Herpes Zoster; Herpes Simplex; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Acyclovir; Famciclovir
• Other Study ID Numbers: F500EMS1010

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No