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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by EMS
Sponsor:
Information provided by (Responsible Party):
EMS
ClinicalTrials.gov Identifier:
NCT01327144
First received: March 30, 2011
Last updated: December 11, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Herpes Zoster
Drug: Famciclovir
Drug: Aciclovir
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by EMS:

Primary Outcome Measures:
  • For efficacy evaluation, a visual analogue scale (VAS) will be used to detect the improvement of symptoms [ Time Frame: day 7 ] [ Designated as safety issue: No ]
    Symptoms evaluated: pain, injury, loss of sensation, burning and itching


Secondary Outcome Measures:
  • Safety will be evaluated by the adverse events occurrences [ Time Frame: day 7 ] [ Designated as safety issue: Yes ]
    Adverse events will be collected and followed in order to evaluate safety and tolerability


Estimated Enrollment: 100
Study Start Date: June 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01327144

Contacts
Contact: Pesquisa Clinica 55 11 38879851 pesquisa.clinica@ems.com.br

Locations
Brazil
Centro de Medicina Reprodutiva Dr Carlos Isaia Filho Recruiting
Porto Alegre, RS, Brazil
Contact: Carlos Isaia Filho, MD    55 51 3222-8180      
Principal Investigator: Carlos Isaia Filho, MD         
Loema Recruiting
Campinas, SP, Brazil, 13010001
Contact: Fabio R Santos, MD       contato@loemaipc.com.br   
Principal Investigator: Fabio R Santos, MD         
CECIP Centro de Estudos Clínicos do Interior Paulista Recruiting
Jau, SP, Brazil
Contact: Paula U. Tokunaga, MD       cecipjau@gmail.com   
Principal Investigator: Paula U. Tokunaga, MD         
Afip - Associacao Fundo de Incentivo A Pesquisa Recruiting
Sao Paulo, SP, Brazil
Contact: Jane Tomimori, MD    55 11 5908 7081      
Principal Investigator: Jane Tomimori, MD         
Alergoclinica Recruiting
Sao Paulo, SP, Brazil, 03066030
Contact: Jussara Marin, MD    55 11 2942-1833      
Principal Investigator: Jussara Marin, MD         
Instituto sirio Libanes de Ensino e Pesquisa Recruiting
Sao Paulo, Sp, Brazil
Contact: Esper Kallas, MD    55 11 3155.8800      
Principal Investigator: Esper Kallas, MD         
Faculdade de Medicina do ABC Recruiting
São Paulo, Brazil
Contact: Carlos Machado, MD         
Principal Investigator: Carlos Machado, MD         
Sponsors and Collaborators
EMS
Investigators
Study Director: Felipe Pinho, MD EMS
  More Information

No publications provided

Responsible Party: EMS
ClinicalTrials.gov Identifier: NCT01327144     History of Changes
Other Study ID Numbers: F500EMS1010
Study First Received: March 30, 2011
Last Updated: December 11, 2013
Health Authority: Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Herpes Zoster
DNA Virus Infections
Herpesviridae Infections
Virus Diseases
2-Aminopurine
Acyclovir
Famciclovir
Anti-Infective Agents
Antimetabolites
Antiviral Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 19, 2014