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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1461 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2006-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Recurrent Genital Herpes

Keywords

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genital herpes herpes famciclovir

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Famciclovir

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Novartis Pharma AG

Role: STUDY_CHAIR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

North Ryde, , Australia

Site Status

Countries

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Australia

Other Identifiers

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CFAM810AAU01

Identifier Type: -

Identifier Source: org_study_id