Efficacy of Oral Famciclovir 125mg Comparing to Aciclovir 200 mg Treatment in Patients With Active Recurrent Genital Herpes
Primary Purpose
GENITAL HERPES
Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Famciclovir
Aciclovir
Sponsored by
About this trial
This is an interventional treatment trial for GENITAL HERPES focused on measuring Herpes Simplex Virus
Eligibility Criteria
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.
Sites / Locations
- Centro de Medicina Reprodutiva Dr Carlos Isaia Filho Ltda
- Hospital de Clínicas de Porto Alegre
- SPVita
- Caep Centro Avancado de Estudos E Pesquisas Ltda
- CEMICAMP - Centro de Pesquisas em Saúde Reprodutiva de Campinas
- CECIP - Centro de Estudos Clínicos do Interior Paulista
- Hospital das Clínicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo
- Instituto Sirio Libanes de Ensino e Pesquisa
- Afip - Associacao Fundo de Incentivo A Psicofarmacologia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Famciclovir 125 mg
Aciclovir 200 mg
Arm Description
1 tablet every 12 hours for 5 days
1 tablet every 4 hours (excluding nocturnal dose) for 5 days
Outcomes
Primary Outcome Measures
Efficacy Will be Evaluated by the Proportion of Subjects With Non Herpes Manifestation
Symptoms evaluated: erythema, papule, vesicle, ulcer, crust, or healed skin.
Secondary Outcome Measures
Safety Will be Evaluated by the Adverse Events Occurence
Adverse events will be collected and followed in order to evaluate safety and tolerability
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01281007
Brief Title
Efficacy of Oral Famciclovir 125mg Comparing to Aciclovir 200 mg Treatment in Patients With Active Recurrent Genital Herpes
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EMS
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
GENITAL HERPES
Keywords
Herpes Simplex Virus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Famciclovir 125 mg
Arm Type
Experimental
Arm Description
1 tablet every 12 hours for 5 days
Arm Title
Aciclovir 200 mg
Arm Type
Active Comparator
Arm Description
1 tablet every 4 hours (excluding nocturnal dose) for 5 days
Intervention Type
Drug
Intervention Name(s)
Famciclovir
Intervention Description
Famciclovir 125 mg every 12 hours for 5 days
Intervention Type
Drug
Intervention Name(s)
Aciclovir
Intervention Description
Aciclovir 200 mg every 4 hours fo 5 days
Primary Outcome Measure Information:
Title
Efficacy Will be Evaluated by the Proportion of Subjects With Non Herpes Manifestation
Description
Symptoms evaluated: erythema, papule, vesicle, ulcer, crust, or healed skin.
Time Frame
Day 5
Secondary Outcome Measure Information:
Title
Safety Will be Evaluated by the Adverse Events Occurence
Description
Adverse events will be collected and followed in order to evaluate safety and tolerability
Time Frame
Day 5
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto Amazonas, MD
Organizational Affiliation
EMS
Official's Role
Study Director
Facility Information:
Facility Name
Centro de Medicina Reprodutiva Dr Carlos Isaia Filho Ltda
City
Porto Alegre
State/Province
RS
Country
Brazil
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
RS
Country
Brazil
Facility Name
SPVita
City
Braganca Paulista
State/Province
SP
Country
Brazil
Facility Name
Caep Centro Avancado de Estudos E Pesquisas Ltda
City
Campinas
State/Province
SP
Country
Brazil
Facility Name
CEMICAMP - Centro de Pesquisas em Saúde Reprodutiva de Campinas
City
Campinas
State/Province
SP
Country
Brazil
Facility Name
CECIP - Centro de Estudos Clínicos do Interior Paulista
City
Jau
State/Province
SP
Country
Brazil
Facility Name
Hospital das Clínicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo
City
Ribeirao Preto
State/Province
SP
ZIP/Postal Code
14048900
Country
Brazil
Facility Name
Instituto Sirio Libanes de Ensino e Pesquisa
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01308-060
Country
Brazil
Facility Name
Afip - Associacao Fundo de Incentivo A Psicofarmacologia
City
Sao Paulo
State/Province
SP
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Oral Famciclovir 125mg Comparing to Aciclovir 200 mg Treatment in Patients With Active Recurrent Genital Herpes
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