Efficacy and Safety of Oral Famciclovir in Patients With Active Recurrent Genital Herpes
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|ClinicalTrials.gov Identifier: NCT00171990|
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : August 15, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Genital Herpes||Drug: Famciclovir||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1461 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Efficacy and Safety of Oral Famciclovir in Patients With Active Recurrent Genital Herpes|
|Study Start Date :||January 2003|
|Actual Study Completion Date :||February 2006|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00171990
|Novartis Investigative Site|
|North Ryde, Australia|
|Study Chair:||Novartis Pharma AG||Novartis Pharmaceuticals|