RELIEF: Randomized Episodic Versus Long-Term Suppression Experience With Famciclovir
This trial will assess whether RGH patients who have two recurrent episodes within a three month period would benefit from suppressive treatment and whether patients prefer episodic therapy or suppressive therapy for the treatment of their RGH.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Study to Determine the Safety and Efficacy of Famciclovir in the Episodic and Suppressive Treatment of Recurrent Genital Herpes (RGH). The Study Will Also Evaluate Quality of Life and Patient Satisfaction|
- Time (days from randomizations) to first recurrence of symptoms of recurrent genital herpes confirmed by PCR.
- Change in total score of the Recurrent Genital Herpes Quality of Life.
- Safety assessed by adverse events.
- Time to first recurrence of genital herpes.
- Number of genital herpes recurrences confirmed by PCR.
|Study Start Date:||June 2003|
|Study Completion Date:||June 2005|
|Primary Completion Date:||June 2005 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00219310
|United States, New Jersey|
|East Hanover, New Jersey, United States|
|Study Chair:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|