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

Phase 3CompletedNCT00171990

Novartis1,461 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,461

Conditions

Recurrent Genital Herpes

Interventions

FamciclovirDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 (1)

Novartis Investigative Site

North Ryde, Australia

Outcomes

Primary Outcomes

Estimated probability being not lesion-free(i.e. not healed) 5.5 elapsed days (132 hours) after patient self-initiation therapy.

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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