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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/NCT00306787
Registration number
NCT00306787
Ethics application status
Date submitted
22/03/2006
Date registered
24/03/2006
Date last updated
30/06/2011
Titles & IDs
Public title
Efficacy and Safety of Famciclovir 1-day Treatment Compared to 3-day Treatment With Valacyclovir in Adults With Recurrent Genital Herpes
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Scientific title
A Multicenter, Randomized, Double-blind Study to Compare the Efficacy and Safety of Patient-initiated Famciclovir 1000 mg b.i.d. x 1 Day to Valacyclovir 500 mg b.i.d. x 3 Days in Immunocompetent Adults With Recurrent Genital Herpes
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Secondary ID [1]
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CFAM810A2308
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Genital Herpes
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Condition category
Condition code
Infection
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Other infectious diseases
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Skin
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Other skin conditions
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Infection
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Sexually transmitted infections
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Renal and Urogenital
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Other renal and urogenital disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Famciclovir
Treatment: Drugs - Valacyclovir
Treatment: Drugs - Placebo matching famciclovir
Treatment: Drugs - Placebo matching valacyclovir
Experimental: Famciclovir - Patients received Famciclovir 1000 mg (2 x 500 mg tablets) twice a day for one day. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions and the second dose approximately 12 hours later. Patients also received 1 valacyclovir placebo capsule, beginning with the first famciclovir dose, twice a day for 3 days, each taken about 12 hours apart.
Active Comparator: Valacyclovir - Patients received Valacyclovir 500 mg capsule twice a day approximately 12 hours apart for 3 consecutive days. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions. On the first day patients also received 2 famciclovir placebo tablets taken with the first 2 doses of Valacyclovir.
Treatment: Drugs: Famciclovir
Famciclovir 500 mg tablet
Treatment: Drugs: Valacyclovir
Valacyclovir 500 mg capsule
Treatment: Drugs: Placebo matching famciclovir
Famciclovir placebo, matching in size, color and forms of famciclovir tablet.
Treatment: Drugs: Placebo matching valacyclovir
Valacyclovir placebo, matching in size, color and forms of valacyclovir capsule.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Investigator-assessed Time to Healing of All Non-aborted Genital Herpes Lesions
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Assessment method [1]
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Time to healing of all non-aborted genital herpes lesions was defined as the time from the first dose of study drug taken no earlier than the recurrence of genital herpes to the investigator-assessed time of healing (i.e. loss of all crusts and re-epithelialization of the lesions; erythema could have been present). Non-aborted lesions are lesions which underwent vesicle, ulcer/soft crust, and/or hard crust formation and required re-epithelialization for healing. The median time was estimated using Kaplan-Meier method by censoring missing values at the time of last clinical lesion observation.
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Timepoint [1]
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72 hours after initiation of study medication up to Day 20
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Secondary outcome [1]
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Percentage of Participants With Aborted Genital Herpes Lesions
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Assessment method [1]
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Lesions that developed no further than the papule stage (erythema may have been present) were considered as aborted lesions. Prodrome also was considered the sign of aborted lesions in this study. Lesions which underwent vesicle, ulcer/soft crust, and/or hard crust formation and required re-epithelialization for healing were considered as non-aborted lesions.
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Timepoint [1]
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72 hours after initiation of study medication up to Day 20
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Secondary outcome [2]
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Investigator-assessed Time to Healing of All (Non-aborted and Aborted) Genital Herpes Lesions
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Assessment method [2]
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Lesions that developed no further than the papule stage (erythema may have been present) were considered as aborted lesions. Prodrome also was considered the sign of aborted lesions in this study. Lesions which underwent vesicle, ulcer/soft crust, and/or hard crust formation and required re-epithelialization for healing were considered as non-aborted lesions. The median time was estimated using Kaplan-Meier method.
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Timepoint [2]
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72 hours after initiation of study medication up to Day 20
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Secondary outcome [3]
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Time to Resolution of Symptoms Associated With Recurrent Genital Herpes
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Assessment method [3]
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Kaplan-Meier estimated time in hours of the resolution of all symptoms (pain, burning, itching, tingling and tenderness) associated with recurrent genital herpes. Kaplan-Meier method is used to estimate the time to resolution of symptoms.
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Timepoint [3]
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72 hours after initiation of study medication up to Day 20
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Secondary outcome [4]
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Number of Patients With a Second Recurrence of Genital Herpes
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Assessment method [4]
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Patients who experienced a first recurrence of genital herpes and took study medication were followed for a period of up to 6 months to the second recurrence.
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Timepoint [4]
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Up to 6 months after investigator assessed healing of first recurrence of genital herpes
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Secondary outcome [5]
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Time to a Second Recurrence of Genital Herpes
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Assessment method [5]
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Patients who experienced a first recurrence of genital herpes and took study medication were followed for a period of up to 6 months to the second recurrence. Time to a second recurrence of genital herpes was calculated in 2 ways as follows:
From the date of treatment initiation no earlier than the recurrence of genital herpes to the date of onset for the second recurrence, or
From the date of healing of non-aborted lesions or confirmation of aborted lesions to the date of onset for the second recurrence.
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Timepoint [5]
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Up to 6 months after investigator assessed healing of first recurrence of genital herpes
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Eligibility
Key inclusion criteria
- At least 18 years old
- History of at least 4 recurrences of genital herpes in the preceding 12 months
- Lesions located on the external genitalia or anogenital region
- Willing to discontinue suppressive treatment
- Documented positive herpes simplex virus (HSV)
- General good health, and history of normal renal function
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Women of childbearing potential not using approved form of contraceptive
- Pregnant or nursing women
- History of hypersensitivity to famciclovir, valacyclovir, or acyclovir
- Known to be immunosuppressed
- Known to have renal dysfunction
- Receiving anti-herpes therapy
- Known to have other genital tract disorders
- Known to have condition which could interfere with drug absorption
Additional protocol-defined inclusion/exclusion criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/02/2008
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Sample size
Target
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Accrual to date
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Final
1179
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Novartis Investigative Site - Darlinghurst
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Recruitment outside Australia
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United States of America
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Alabama
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Colorado
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Germany
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Augsburg
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Berlin
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Freiburg
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Germany
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Rostock
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Germany
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Wolfsburg
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novartis Pharmaceuticals
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This study will assess the safety and efficacy of one-day famciclovir (1000 mg twice a day
(b.i.d)) in reducing the duration of genital herpes lesions and the associated symptoms
compared to three-day treatment with valacyclovir (500 mg capsule b.i.d).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00306787
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Novartis Pharmaceuticals
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Address
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Novartis Pharmaceuticals
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00306787
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