Efficacy and Safety of Oral Famciclovir in Patients With Active Recurrent Genital Herpes
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Efficacy and Safety of Oral Famciclovir in Patients With Active Recurrent Genital Herpes|
- Estimated probability being not lesion-free(i.e. not healed) 5.5 elapsed days (132 hours) after patient self-initiation therapy.
- 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.
|Study Start Date:||January 2003|
|Study Completion Date:||February 2006|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00171990
|Novartis Investigative Site|
|North Ryde, Australia|
|Study Chair:||Novartis Pharma AG||Novartis Pharmaceuticals|