- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01281007
Efficacy of Oral Famciclovir 125mg Comparing to Aciclovir 200 mg Treatment in Patients With Active Recurrent Genital Herpes
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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RS
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Porto Alegre, RS, Brazil
- Hospital de Clinicas de Porto Alegre
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Porto Alegre, RS, Brazil
- Centro de Medicina Reprodutiva Dr Carlos Isaia Filho Ltda
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SP
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Braganca Paulista, SP, Brazil
- SPVita
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Campinas, SP, Brazil
- Caep Centro Avancado de Estudos E Pesquisas Ltda
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Campinas, SP, Brazil
- CEMICAMP - Centro de Pesquisas em Saúde Reprodutiva de Campinas
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Jau, SP, Brazil
- CECIP - Centro de Estudos Clínicos do Interior Paulista
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Ribeirao Preto, SP, Brazil, 14048900
- Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo
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Sao Paulo, SP, Brazil, 01308-060
- Instituto Sirio Libanes de Ensino e Pesquisa
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Sao Paulo, SP, Brazil
- Afip - Associacao Fundo de Incentivo A Psicofarmacologia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
- Patients must be able to understand the study procedures agree to participate and give written consent.
- Patients with clinical diagnosis of recurrent genital herpes;
- Score symptoms higher than 4;
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Famciclovir 125 mg
1 tablet every 12 hours for 5 days
|
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
|
Aciclovir 200 mg every 4 hours fo 5 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Day 5
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Day 5
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Roberto Amazonas, MD, EMS
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Virus Diseases
- Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- DNA Virus Infections
- Skin Diseases, Infectious
- Skin Diseases, Viral
- Herpesviridae Infections
- Herpes Simplex
- Herpes Genitalis
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Acyclovir
- Famciclovir
Other Study ID Numbers
- F125EMS1010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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