Skip to main content
OpenTrials
Completed

NCT Number: NCT00171990

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Recurrent Genital Herpes Communicable Diseases DNA Virus Infections Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Diseases, Male Herpes Genitalis Herpes Simplex Herpesviridae Infections Infections Male Urogenital Diseases Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Skin Diseases Skin Diseases, Infectious Skin Diseases, Viral Skin and Connective Tissue Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site

North Ryde, Australia

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Famciclovir

Drug

Primary outcomes

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

Secondary outcomes

  1. Safety and tolerability assessed by AEs.

  2. Time between recurrences of genital herpes.

  3. 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.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Important dates

Study start
2003
Study completion
2006
First posted
Sep 15, 2005
Registry last updated
Aug 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.