Clinical Trial: Efficacy and Safety of Oral Famciclovir in Patients With Active Recurrent Genital Herpes
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Efficacy and Safety of Oral Famciclovir in Patients With Active Recurrent Genital Herpes
Brief Summary:
This is a phase III, multicenter, randomized, double-blind, parallel-group study to compare the efficacy and safety of a two-day treatment with famciclovir (500 mg loading dose followed by 250 mg 12-hourly) to standard five-day treatment with famciclovir (125 mg 12-hourly) in patients with active recurrent genital herpes.
This study is not recruiting patients in the United States.
Detailed Summary:
Sponsor: Novartis
Current Primary Outcome: Estimated probability being not lesion-free(i.e. not healed) 5.5 elapsed days (132 hours) after patient self-initiation therapy.
Original Primary Outcome:
Current Secondary Outcome:
- Safety and tolerability assessed by AEs.
- Time between recurrences of genital herpes.
- Proportion of aborted (i.e. lesions did not appear)genital herpes recurrences. Change from baseline in symptoms or impairment. Change form baseline in functioning or disability.
Original Secondary Outcome:
Information By: Novartis
Dates:
Date Received: September 13, 2005
Date Started: January 2003
Date Completion:
Last Updated: August 14, 2013
Last Verified: August 2013
