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

Information source: EMS
ClinicalTrials.gov processed this data on November 27, 2014
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Herpes Zoster

Intervention: Famciclovir (Drug); Aciclovir (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: EMS

Official(s) and/or principal investigator(s):
Felipe Pinho, MD, Study Director, Affiliation: EMS

Overall contact:
Pesquisa Clinica, Phone: 55 11 38879851, Email: pesquisa.clinica@ems.com.br

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Secondary outcome: Safety will be evaluated by the adverse events occurrences

Detailed description: Study Design

- Open-label, prospective, parallel group, intent to treat trial

- Experiment duration: 7 days

- 2 visits (days 0, and 7)

- Reduction of symptoms

- Adverse events evaluation

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

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.

Locations and Contacts

Pesquisa Clinica, Phone: 55 11 38879851, Email: pesquisa.clinica@ems.com.br

Faculdade de Medicina do ABC, São Paulo, Brazil; Recruiting
Carlos Machado, MD
Carlos Machado, MD, Principal Investigator

Centro de Medicina Reprodutiva Dr Carlos Isaia Filho, Porto Alegre, RS, Brazil; Recruiting
Carlos Isaia Filho, MD, Phone: 55 51 3222-8180
Carlos Isaia Filho, MD, Principal Investigator

Loema, Campinas, SP 13010001, Brazil; Recruiting
Fabio R Santos, MD, Email: contato@loemaipc.com.br
Fabio R Santos, MD, Principal Investigator

CECIP Centro de Estudos Clínicos do Interior Paulista, Jau, SP, Brazil; Recruiting
Paula U. Tokunaga, MD, Email: cecipjau@gmail.com
Paula U. Tokunaga, MD, Principal Investigator

Afip - Associacao Fundo de Incentivo A Pesquisa, Sao Paulo, SP, Brazil; Recruiting
Jane Tomimori, MD, Phone: 55 11 5908 7081
Jane Tomimori, MD, Principal Investigator

Alergoclinica, Sao Paulo, SP 03066030, Brazil; Recruiting
Jussara Marin, MD, Phone: 55 11 2942-1833
Jussara Marin, MD, Principal Investigator

Instituto sirio Libanes de Ensino e Pesquisa, Sao Paulo, Sp, Brazil; Recruiting
Esper Kallas, MD, Phone: 55 11 3155.8800
Esper Kallas, MD, Principal Investigator

Additional Information

Starting date: June 2012
Last updated: December 11, 2013

Page last updated: November 27, 2014

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