Efficacy and Safety of Oral Famciclovir in Patients With Active Recurrent Genital Herpes
Information source: Novartis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Recurrent Genital Herpes
Intervention: Famciclovir (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Novartis Pharma AG, Study Chair, Affiliation: Novartis
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.
Clinical Details
Official title: Efficacy and Safety of Oral Famciclovir in Patients With Active Recurrent Genital Herpes
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Estimated probability being not lesion-free(i.e. not healed) 5.5 elapsed days (132 hours) after patient self-initiation therapy.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Diagnosis of genital herpes
- Had at least 2 recurrences in past 12 months or 1 recurrence in past 6 months
Exclusion Criteria:
- - Currently taking suppressive herpes antiviral therapy
- Females who are pregnant, breast feeding or planning to become pregnant during study
- History of allergy to famciclovir or similar products (e. g. aciclovir, valaciclovir)
Other protocol-defined exclusion criteria may apply.
Locations and Contacts
This study is not being conducted in the United States, North Ryde, Australia
Additional Information
Click here to receive more information about this study
Starting date: January 2003
Ending date: February 2006
Last updated: December 7, 2007
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