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History of Changes for Study: NCT01327144
Efficacy of Oral Famciclovir Versus Aciclovir Treatment in Patients With Herpes Zoster
Latest version (submitted April 15, 2019) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 March 31, 2011 None (earliest Version on record)
2 February 26, 2013 Recruitment Status, Study Status, Contacts/Locations, Sponsor/Collaborators and Oversight
3 September 24, 2013 Study Status and Study Description
4 October 7, 2013 Study Status and Contacts/Locations
5 December 11, 2013 Contacts/Locations and Study Status
6 July 30, 2015 Contacts/Locations and Study Status
7 February 3, 2017 Study Status, Study Design, Oversight and Study Description
8 April 15, 2019 Recruitment Status, Study Status, Contacts/Locations, Study Design and References
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Study NCT01327144
Submitted Date:  July 30, 2015 (v6)

Open or close this module Study Identification
Unique Protocol ID: F500EMS1010
Brief Title: Efficacy of Oral Famciclovir Versus Aciclovir Treatment in Patients With Herpes Zoster
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
Secondary IDs:
Open or close this module Study Status
Record Verification: July 2015
Overall Status: Recruiting
Study Start: June 2012
Primary Completion: July 2016 [Anticipated]
Study Completion: July 2016 [Anticipated]
First Submitted: March 30, 2011
First Submitted that
Met QC Criteria:
March 31, 2011
First Posted: April 1, 2011 [Estimate]
Last Update Submitted that
Met QC Criteria:
July 30, 2015
Last Update Posted: July 31, 2015 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: EMS
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
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.

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
Open or close this module Conditions
Conditions: Herpes Zoster
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 100 [Anticipated]
Open or close this module Arms and Interventions
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
Open or close this module Outcome Measures
Primary Outcome Measures:
1. For efficacy evaluation, a visual analogue scale (VAS) will be used to detect the improvement of symptoms
Symptoms evaluated: pain, injury, loss of sensation, burning and itching

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

[Time Frame: day 7]
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 60 Years
Sex: All
Gender Based:
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.
Open or close this module Contacts/Locations
Central Contact Person: Pesquisa Clinica
Telephone: 55 11 38879851
Email: pesquisa.clinica@ems.com.br
Study Officials: Joyce Silva, MD
Study Director
EMS
Locations: Brazil, RS
Centro de Medicina Reprodutiva Dr Carlos Isaia Filho
[Recruiting]
Porto Alegre, RS, Brazil
Contact:Contact: Carlos Isaia Filho, MD 55 51 3222-8180
Contact:Principal Investigator: Carlos Isaia Filho, MD
Brazil, São Paulo
Allergisa
[Recruiting]
Campinas, São Paulo, Brazil
Contact:Contact: Andre L Vergnanini, MD +55193789-8600
Contact:Principal Investigator: André L Vergnanini, MD
Brazil, SP
Loema
[Recruiting]
Campinas, SP, Brazil, 13010001
Contact:Contact: Fabio R Santos, MD contato@loemaipc.com.br
Contact:Principal Investigator: Fabio R Santos, MD
CECIP Centro de Estudos Clínicos do Interior Paulista
[Recruiting]
Jau, SP, Brazil
Contact:Contact: Paula U. Tokunaga, MD cecipjau@gmail.com
Contact:Principal Investigator: Paula U. Tokunaga, MD
Afip - Associacao Fundo de Incentivo A Pesquisa
[Recruiting]
Sao Paulo, SP, Brazil
Contact:Contact: Jane Tomimori, MD 55 11 5908 7081
Contact:Principal Investigator: Jane Tomimori, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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