NCT00171990

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,461

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2003

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

August 15, 2013

Status Verified

August 1, 2013

First QC Date

September 13, 2005

Last Update Submit

August 14, 2013

Conditions

Recurrent Genital Herpes

Keywords

genital herpesherpesfamciclovir

Outcome Measures

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 (3)

  • 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.

Interventions

FamciclovirDRUG

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of genital herpes
  • Had at least 2 recurrences in past 12 months or 1 recurrence in past 6 months

You may not qualify if:

  • \- 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Investigative Site

North Ryde, Australia

Location

MeSH Terms

Conditions

Herpes GenitalisHerpes Simplex

Interventions

Famciclovir

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGenital Diseases, MaleMale Urogenital DiseasesSkin Diseases, ViralSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

AdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Novartis Pharma AG

    Novartis Pharmaceuticals

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

January 1, 2003

Study Completion

February 1, 2006

Last Updated

August 15, 2013

Record last verified: 2013-08

Locations

AU(1)