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...
Date First Received: September 13, 2005
Last Updated: August 4, 2008
Verified by: Novartis, August 2006
Clinical Trial Phase: Phase 3 | Start Date: January 2003
Overall Status: Completed
Brief Summary
Official Title: “Efficacy and Safety of Oral Famciclovir in Patients With Active Recurrent Genital Herpes”
Condition Keyword(s):
Intervention(s):
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 Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: Famciclovir
Outcome Measures for this Clinical Trial
Primary Measures
- Estimated probability being not lesion-free(i.e. not healed) 5.5 elapsed days (132 hours) after patient self-initiation therapy.
Secondary Measures
- 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.
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Clinical Trial Sponsor Information
Lead Sponsor: Novartis
Overall Clinical Trial Officials and Contacts
Novartis Pharma AG Study Chair Novartis
Additional Information
Information obtained from ClinicalTrials.gov on September 05, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00171990
Study ID Number: CFAM810AAU01
ClinicalTrials.gov Identifier: NCT00171990
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Clinical Trials Authorship and Review
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