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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00171990




Registration number
NCT00171990
Ethics application status
Date submitted
13/09/2005
Date registered
15/09/2005
Date last updated
15/08/2013

Titles & IDs
Public title
Efficacy and Safety of Oral Famciclovir in Patients With Active Recurrent Genital Herpes
Scientific title
Efficacy and Safety of Oral Famciclovir in Patients With Active Recurrent Genital Herpes
Secondary ID [1] 0 0
CFAM810AAU01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Recurrent Genital Herpes 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Skin 0 0 0 0
Other skin conditions
Infection 0 0 0 0
Sexually transmitted infections
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Famciclovir

Treatment: Drugs: Famciclovir
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Estimated probability being not lesion-free(i.e. not healed) 5.5 elapsed days (132 hours) after patient self-initiation therapy.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Safety and tolerability assessed by AEs.
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Time between recurrences of genital herpes.
Timepoint [2] 0 0
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0

Eligibility
Key inclusion criteria
- Diagnosis of genital herpes

- Had at least 2 recurrences in past 12 months or 1 recurrence in past 6 months
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2006
Sample size
Target
Accrual to date
Final
1461
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Novartis Investigative Site - North Ryde
Recruitment postcode(s) [1] 0 0
- North Ryde

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT00171990
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharma AG
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00171990