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Efficacy of Oral Famciclovir 125mg Comparing to Aciclovir 200 mg Treatment in Patients With Active Recurrent Genital Herpes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01281007
First Posted: January 21, 2011
Last Update Posted: July 7, 2015
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.
Information provided by (Responsible Party):
EMS
  Purpose

Recurrent genital herpes is a commonly occurring sexually transmitted disease caused by herpes simplex virus (HSV). There are effective oral prescription antiviral medicines available to reduce the discomfort of symptoms, such as famciclovir and aciclovir.

This is a phase III, multicenter, randomized, parallel-group study to compare the efficacy and safety of treatment with famciclovir (125 mg) versus aciclovir (200 mg) in patients with active recurrent genital herpes.


Condition Intervention Phase
GENITAL HERPES Drug: Famciclovir Drug: Aciclovir Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Multicenter Study of the Efficacy and Safety of Famciclovir 125 mg Comparing to Aciclovir 200 mg in Patients With Active Recurrent Genital Herpes

Resource links provided by NLM:


Further study details as provided by EMS:

Primary Outcome Measures:
  • Efficacy Will be Evaluated by the Proportion of Subjects With Non Herpes Manifestation [ Time Frame: Day 5 ]
    Symptoms evaluated: erythema, papule, vesicle, ulcer, crust, or healed skin.


Secondary Outcome Measures:
  • Safety Will be Evaluated by the Adverse Events Occurence [ Time Frame: Day 5 ]
    Adverse events will be collected and followed in order to evaluate safety and tolerability


Enrollment: 150
Study Start Date: July 2012
Study Completion Date: March 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Famciclovir 125 mg
1 tablet every 12 hours for 5 days
Drug: Famciclovir
Famciclovir 125 mg every 12 hours for 5 days
Active Comparator: Aciclovir 200 mg
1 tablet every 4 hours (excluding nocturnal dose) for 5 days
Drug: Aciclovir
Aciclovir 200 mg every 4 hours fo 5 days

Detailed Description:

STUDY DESIGN

  • Open-label, prospective, parallel group, intent to treat trial
  • Experiment duration: 5 days
  • 2 visits (days 1, and 5)
  • Reduction of symptoms
  • Adverse events evaluation
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Patients must be able to understand the study procedures agree to participate and give written consent.
  2. Patients with clinical diagnosis of recurrent genital herpes;
  3. Score symptoms higher than 4;
  4. Negative pregnant urine test.

Exclusion criteria:

  1. Pregnancy or risk of pregnancy.
  2. Lactation
  3. Any pathology or past medical condition that can interfere with this protocol.
  4. Non-steroidal anti-inflammatory drug , hormonal anti-inflammatory or immunosuppressive drugs (in the last 30 days and during the study);
  5. Patients with immunodeficiency and/or immunosuppressive disease;
  6. Hypersensitivity to components of the formula;
  7. Other conditions deemed reasonable by the medical investigator as to the disqualification of the individual from study participation.
  Contacts and Locations
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): NCT01281007


Locations
Brazil
Centro de Medicina Reprodutiva Dr Carlos Isaia Filho Ltda
Porto Alegre, RS, Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, RS, Brazil
SPVita
Braganca Paulista, SP, Brazil
Caep Centro Avancado de Estudos E Pesquisas Ltda
Campinas, SP, Brazil
CEMICAMP - Centro de Pesquisas em Saúde Reprodutiva de Campinas
Campinas, SP, Brazil
CECIP - Centro de Estudos Clínicos do Interior Paulista
Jau, SP, Brazil
Hospital das Clínicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo
Ribeirao Preto, SP, Brazil, 14048900
Instituto Sirio Libanes de Ensino e Pesquisa
Sao Paulo, SP, Brazil, 01308-060
Afip - Associacao Fundo de Incentivo A Psicofarmacologia
Sao Paulo, SP, Brazil
Sponsors and Collaborators
EMS
Investigators
Study Director: Roberto Amazonas, MD EMS
  More Information

Responsible Party: EMS
ClinicalTrials.gov Identifier: NCT01281007     History of Changes
Other Study ID Numbers: F125EMS1010
First Submitted: January 20, 2011
First Posted: January 21, 2011
Results First Submitted: May 29, 2015
Results First Posted: July 7, 2015
Last Update Posted: July 7, 2015
Last Verified: July 2015

Keywords provided by EMS:
Herpes Simplex Virus

Additional relevant MeSH terms:
Herpes Genitalis
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Genital Diseases, Male
Genital Diseases, Female
Acyclovir
Famciclovir
2-Aminopurine
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action