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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00171990
First Posted: September 15, 2005
Last Update Posted: August 15, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Novartis
  Purpose

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.


Condition Intervention Phase
Recurrent Genital Herpes Drug: Famciclovir Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Oral Famciclovir in Patients With Active Recurrent Genital Herpes

Resource links provided by NLM:


Further study details as provided by Novartis:

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.

Enrollment: 1461
Study Start Date: January 2003
Study Completion Date: February 2006
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00171990


Locations
Australia
Novartis Investigative Site
North Ryde, Australia
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Pharma AG Novartis Pharmaceuticals
  More Information

ClinicalTrials.gov Identifier: NCT00171990     History of Changes
Other Study ID Numbers: CFAM810AAU01
First Submitted: September 13, 2005
First Posted: September 15, 2005
Last Update Posted: August 15, 2013
Last Verified: August 2013

Keywords provided by Novartis:
genital herpes
herpes
famciclovir

Additional relevant MeSH terms:
Herpes Genitalis
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Genital Diseases, Male
Genital Diseases, Female
Famciclovir
2-Aminopurine
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action