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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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

Sponsor: EMS

Current Primary Outcome: Efficacy Will be Evaluated by the Proportion of Subjects With Non Herpes Manifestation [ Time Frame: Day 5 ]

Symptoms evaluated: erythema, papule, vesicle, ulcer, crust, or healed skin.


Original Primary Outcome: Same as current

Current Secondary Outcome: Safety Will be Evaluated by the Adverse Events Occurence [ Time Frame: Day 5 ]

Adverse events will be collected and followed in order to evaluate safety and tolerability


Original Secondary Outcome: Same as current

Information By: EMS

Dates:
Date Received: January 20, 2011
Date Started: July 2012
Date Completion:
Last Updated: July 3, 2015
Last Verified: July 2015