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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00171990
First received: September 13, 2005
Last updated: August 14, 2013
Last verified: August 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00171990

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

No publications provided

ClinicalTrials.gov Identifier: NCT00171990     History of Changes
Other Study ID Numbers: CFAM810AAU01
Study First Received: September 13, 2005
Last Updated: August 14, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

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
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014