Efficacy and Safety of Oral Famciclovir in Patients With Active Recurrent Genital Herpes

Recurrent Genital Herpes Clinical Trial

Official title:

Efficacy and Safety of Oral Famciclovir in Patients With Active Recurrent Genital Herpes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00171990
• Other study ID #: CFAM810AAU01
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: August 14, 2013
• Start date: January 2003
• Est. completion date: February 2006

Study information

• Verified date: August 2013
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1461
• Est. completion date: February 2006
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Herpes Genitalis
• Recurrent Genital Herpes

Intervention

Drug:
• Famciclovir

Locations

Country	Name	City	State
Australia	Novartis Investigative Site	North Ryde

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimated probability being not lesion-free(i.e. not healed) 5.5 elapsed days (132 hours) after patient self-initiation therapy.
Secondary	Safety and tolerability assessed by AEs.
Secondary	Time between recurrences of genital herpes.
Secondary	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.