GENITAL HERPES Clinical Trial
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
NCT number | NCT01281007 |
Other study ID # | F125EMS1010 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | July 2012 |
Est. completion date | March 2015 |
Verified date | July 2015 |
Source | EMS |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 150 |
Est. completion date | March 2015 |
Est. primary completion date | January 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
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 | Centro de Medicina Reprodutiva Dr Carlos Isaia Filho Ltda | Porto Alegre | RS |
Brazil | Hospital de Clínicas de Porto Alegre | Porto Alegre | RS |
Brazil | Hospital das Clínicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo | Ribeirao Preto | SP |
Brazil | Afip - Associacao Fundo de Incentivo A Psicofarmacologia | Sao Paulo | SP |
Brazil | Instituto Sirio Libanes de Ensino e Pesquisa | Sao Paulo | SP |
Lead Sponsor | Collaborator |
---|---|
EMS |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
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