Efficacy of Oral Famciclovir 125mg Comparing to Aciclovir 200 mg Treatment in Patients With Active Recurrent Genital Herpes

Phase 3

Completed

• Conditions: GENITAL HERPES
• Interventions: Drug: Famciclovir; Drug: Aciclovir

• Registration Number: NCT01281007
• Lead Sponsor: EMS

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

Study Timeline

• Study First Submitted: 2011-01-20
• Study First Submitted QC: 2011-01-20
• Study First Posted: 2011-01-21
• Study Start: 2012-07
• Primary Completion: 2015-01
• Study Completion: 2015-03
• Results First Submitted: 2015-05-29
• Status Verified: 2015-07
• Results First Submitted QC: 2015-07-03
• Results First Posted: 2015-07-07
• Last Update Submitted: 2021-03-30
• Last Update Posted: 2021-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Famciclovir 125 mg	Famciclovir	1 tablet every 12 hours for 5 days
Aciclovir 200 mg	Aciclovir	1 tablet every 4 hours (excluding nocturnal dose) for 5 days

Primary Outcome Measures

Name	Time	Method
Efficacy Will be Evaluated by the Proportion of Subjects With Non Herpes Manifestation	Day 5	Symptoms evaluated: erythema, papule, vesicle, ulcer, crust, or healed skin.

Secondary Outcome Measures

Name	Time	Method
Safety Will be Evaluated by the Adverse Events Occurence	Day 5	Adverse events will be collected and followed in order to evaluate safety and tolerability

Trial Locations

Locations (9)

Hospital de Clínicas de Porto Alegre; 🇧🇷 Porto Alegre, RS, Brazil

Caep Centro Avancado de Estudos E Pesquisas Ltda; 🇧🇷 Campinas, SP, Brazil

Centro de Medicina Reprodutiva Dr Carlos Isaia Filho Ltda; 🇧🇷 Porto Alegre, RS, Brazil

SPVita; 🇧🇷 Braganca Paulista, 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, Brazil

Instituto Sirio Libanes de Ensino e Pesquisa; 🇧🇷 Sao Paulo, SP, Brazil

Afip - Associacao Fundo de Incentivo A Psicofarmacologia; 🇧🇷 Sao Paulo, SP, Brazil