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Completed

NCT Number: NCT01327144

Efficacy of Oral Famciclovir Versus Aciclovir Treatment 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.

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Key information

Conditions

Herpes Zoster DNA Virus Infections Herpesviridae Infections Infections Varicella Zoster Virus Infection Virus Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centro de Medicina Reprodutiva Dr Carlos Isaia Filho, Porto Alegre, Rio Grande do Sul, Brazil

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Famciclovir

Drug

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

Aciclovir

Drug

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

Primary outcomes

  1. For efficacy evaluation, a visual analogue scale (VAS) will be used to detect the improvement of symptoms

    Time frame: day 7

    Symptoms evaluated: pain, injury, loss of sensation, burning and itching

Secondary outcomes

  1. Safety will be evaluated by the adverse events occurrences

    Time frame: day 7

    Adverse events will be collected and followed in order to evaluate safety and tolerability

Sponsors and collaborators

Lead sponsor

EMS

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Apr 1, 2011
Registry last updated
Apr 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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