Efficacy of Oral Famciclovir 125mg Comparing to Aciclovir 200 mg Treatment in Patients With Active Recurrent Genital Herpes
Information source: EMS
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: GENITAL HERPES
Intervention: Famciclovir (Drug); Aciclovir (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: EMS Official(s) and/or principal investigator(s):
Roberto Amazonas, MD, Study Director, Affiliation: EMS
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Efficacy Will be Evaluated by the Proportion of Subjects With Non Herpes Manifestation
Secondary outcome: Safety Will be Evaluated by the Adverse Events Occurence
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
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 14048900, Brazil
Afip - Associacao Fundo de Incentivo A Psicofarmacologia, Sao Paulo, SP, Brazil
Instituto Sirio Libanes de Ensino e Pesquisa, Sao Paulo, SP 01308-060, Brazil
Additional Information
Starting date: July 2012
Last updated: July 3, 2015
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