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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01327144
Recruitment Status : Completed
First Posted : April 1, 2011
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Herpes Zoster Drug: Famciclovir Drug: Aciclovir Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 177 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : June 2012
Actual Primary Completion Date : May 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shingles

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01327144


Locations
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Brazil
Centro de Medicina Reprodutiva Dr Carlos Isaia Filho
Porto Alegre, RS, Brazil
Loema
Campinas, SP, Brazil, 13010001
CECIP Centro de Estudos Clínicos do Interior Paulista
Jau, SP, Brazil
Afip - Associacao Fundo de Incentivo A Pesquisa
Sao Paulo, SP, Brazil
Allergisa
Campinas, São Paulo, Brazil
Sponsors and Collaborators
EMS
Investigators
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Study Director: Joyce Silva, MD EMS

Publications of Results:
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Responsible Party: EMS
ClinicalTrials.gov Identifier: NCT01327144     History of Changes
Other Study ID Numbers: F500EMS1010
First Posted: April 1, 2011    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Herpes Zoster
Varicella Zoster Virus Infection
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Acyclovir
Famciclovir
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action