Back to resultsEfficacy and Safety of Oral Famciclovir in Patients With Active Recurrent Genital Herpes
Primary Purpose
Recurrent Genital Herpes
Status
Completed
Phase
Phase 3
Locations
Australia
Study Type
Interventional
Intervention
Famciclovir
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent Genital Herpes focused on measuring genital herpes, herpes, famciclovir
Eligibility 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.
Sites / Locations
- Novartis Investigative Site
Outcomes
Primary Outcome Measures
Estimated probability being not lesion-free(i.e. not healed) 5.5 elapsed days (132 hours) after patient self-initiation therapy.
Secondary Outcome 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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00171990
Brief Title
Efficacy and Safety of Oral Famciclovir in Patients With Active Recurrent Genital Herpes
Official Title
Efficacy and Safety of Oral Famciclovir in Patients With Active Recurrent Genital Herpes
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Genital Herpes
Keywords
genital herpes, herpes, famciclovir
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
1461 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Famciclovir
Primary Outcome Measure Information:
Title
Estimated probability being not lesion-free(i.e. not healed) 5.5 elapsed days (132 hours) after patient self-initiation therapy.
Secondary Outcome Measure Information:
Title
Safety and tolerability assessed by AEs.
Title
Time between recurrences of genital herpes.
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharma AG
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Chair
Facility Information:
Facility Name
Novartis Investigative Site
City
North Ryde
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Oral Famciclovir in Patients With Active Recurrent Genital Herpes
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