NCT01281007

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: EMS · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• GENITAL HERPES

Interventions

Type	Name	Description
DRUG	Famciclovir	Famciclovir 125 mg every 12 hours for 5 days
DRUG	Aciclovir	Aciclovir 200 mg every 4 hours fo 5 days

Timeline

• Start date: 2012-07-01
• Primary completion: 2015-01-01
• Completion: 2015-03-01
• First posted: 2011-01-21
• Last updated: 2021-04-21
• Results posted: 2015-07-07

Locations

9 sites across 1 country: Brazil