Clinical Trial: A Study to Evaluate the Safety and Efficacy of Single Day or Single Dose Famciclovir for the Treatment of Recurrent Herpes Labialis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Randomized, Multicenter, Double-Blinded Controlled Study to Compare the Effectiveness of a Single Dose (1500 mg) of Famciclovir, One Day (750 mg q12) of Famciclovir and Placebo in Patient-Initiated
Brief Summary: The study is designed to assess the efficacy and safety of patient-initiated therapy with famciclovir 1500 mg o.d. or 750 mg b.i.d. for one day treatment in adult men and women with recurrent herpes labialis
Detailed Summary:
Sponsor: Novartis
Current Primary Outcome: Time to healing of the primary lesion complex (loss of crust from vesicular [classical] lesions)
Original Primary Outcome:
Current Secondary Outcome:
- safety and tolerability assessed by adverse events (AEs)
- resolution of pain / discomfort after short-course regimens
- proportion of patients with aborted lesions
- time to healing of all vesicular lesions
- time to healing of all aborted (non-vesicular) lesions
Original Secondary Outcome:
Information By: Novartis
Dates:
Date Received: November 2, 2005
Date Started: October 2003
Date Completion:
Last Updated: December 7, 2007
Last Verified: August 2006
