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

Last updated: April 15, 2019
Sponsor: EMS
Overall Status: Completed

Phase

3

Condition

Herpes Simplex Infections

Chickenpox (Varicella Zoster Infection)

Rash

Treatment

N/A

Clinical Study ID

NCT01327144
F500EMS1010
  • Ages 18-60
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients must be able to understand the study procedures, agree to participate andgive 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

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 immunosuppressivedrugs (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 thedisqualification of the individual from study participation.

Study Design

Total Participants: 177
Study Start date:
June 01, 2012
Estimated Completion Date:
July 31, 2017

Study 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

Connect with a study center

  • Centro de Medicina Reprodutiva Dr Carlos Isaia Filho

    Porto Alegre, RS
    Brazil

    Site Not Available

  • Loema

    Campinas, SP 13010001
    Brazil

    Site Not Available

  • CECIP Centro de Estudos Clínicos do Interior Paulista

    Jau, SP
    Brazil

    Site Not Available

  • Afip - Associacao Fundo de Incentivo A Pesquisa

    Sao Paulo, SP
    Brazil

    Site Not Available

  • Allergisa

    Campinas, São Paulo
    Brazil

    Site Not Available

  • Faculdade de Medicina do ABC

    São Paulo,
    Brazil

    Site Not Available

  • Faculdade de Medicina do ABC

    São Paulo,
    Brazil

    Site Not Available

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