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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 DESIGN
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Famciclovir 125 mg | Experimental | 1 tablet every 12 hours for 5 days |
|
| Aciclovir 200 mg | Active Comparator | 1 tablet every 4 hours (excluding nocturnal dose) for 5 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Famciclovir | Drug | Famciclovir 125 mg every 12 hours for 5 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy Will be Evaluated by the Proportion of Subjects With Non Herpes Manifestation | Symptoms evaluated: erythema, papule, vesicle, ulcer, crust, or healed skin. | Day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Will be Evaluated by the Adverse Events Occurence | Adverse events will be collected and followed in order to evaluate safety and tolerability | Day 5 |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roberto Amazonas, MD | EMS | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Medicina Reprodutiva Dr Carlos Isaia Filho Ltda | Porto Alegre | Rio Grande do Sul | Brazil | |||
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| ID | Title | Description |
|---|---|---|
| FG000 | Famciclovir 125 mg | 1 tablet every 12 hours for 5 days Famciclovir: Famciclovir 125 mg every 12 hours for 5 days |
| FG001 | Aciclovir 200 mg | 1 tablet every 4 hours (excluding nocturnal dose) for 5 days Aciclovir: Aciclovir 200 mg every 4 hours fo 5 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Famciclovir 125 mg | 1 tablet every 12 hours for 5 days Famciclovir: Famciclovir 125 mg every 12 hours for 5 days |
| BG001 | Aciclovir 200 mg | 1 tablet every 4 hours (excluding nocturnal dose) for 5 days Aciclovir: Aciclovir 200 mg every 4 hours fo 5 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Efficacy Will be Evaluated by the Proportion of Subjects With Non Herpes Manifestation | Symptoms evaluated: erythema, papule, vesicle, ulcer, crust, or healed skin. | Posted | Number | subjects | Day 5 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Famciclovir 125 mg | 1 tablet every 12 hours for 5 days Famciclovir: Famciclovir 125 mg every 12 hours for 5 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manager of Clinical Trials | EMS | +5501938874176 | pesquisa.clinica@ems.com.br |
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| ID | Term |
|---|---|
| D006558 | Herpes Genitalis |
| D006561 | Herpes Simplex |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000077595 | Famciclovir |
| D000212 | Acyclovir |
| ID | Term |
|---|---|
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Aciclovir |
| Drug |
Aciclovir 200 mg every 4 hours fo 5 days |
|
| Hospital de Clínicas de Porto Alegre |
| Porto Alegre |
| Rio Grande do Sul |
| Brazil |
| SPVita | Bragança Paulista | São Paulo | Brazil |
| Caep Centro Avancado de Estudos E Pesquisas Ltda | Campinas | São Paulo | Brazil |
| CEMICAMP - Centro de Pesquisas em Saúde Reprodutiva de Campinas | Campinas | São Paulo | Brazil |
| CECIP - Centro de Estudos Clínicos do Interior Paulista | Jaú | São Paulo | Brazil |
| Hospital das Clínicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo | Ribeirão Preto | São Paulo | 14048900 | Brazil |
| Instituto Sirio Libanes de Ensino e Pesquisa | São Paulo | São Paulo | 01308-060 | Brazil |
| Afip - Associacao Fundo de Incentivo A Psicofarmacologia | São Paulo | São Paulo | Brazil |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Safety Will be Evaluated by the Adverse Events Occurence | Adverse events will be collected and followed in order to evaluate safety and tolerability | Not Posted | Day 5 | Participants |
| 0 |
| 75 |
| 10 |
| 75 |
| EG001 | Aciclovir 200 mg | 1 tablet every 4 hours (excluding nocturnal dose) for 5 days Aciclovir: Aciclovir 200 mg every 4 hours fo 5 days | 0 | 75 | 12 | 75 |
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| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D005832 | Genital Diseases, Male |
| D052801 | Male Urogenital Diseases |
| D017193 | Skin Diseases, Viral |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006571 |
| Heterocyclic Compounds |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |