Efficacy and Safety of Famciclovir 1-day Treatment Compared to 3-day Treatment With Valacyclovir in Adults With Recurrent Genital Herpes

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00306787
First received: March 22, 2006
Last updated: June 28, 2011
Last verified: June 2011
Results First Received: August 20, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Genital Herpes
Interventions: Drug: Famciclovir
Drug: Valacyclovir
Drug: Placebo matching famciclovir
Drug: Placebo matching valacyclovir

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 1179 patients were randomized in the study and followed to their first genital herpes recurrence. A total of 423 patients did not experience a recurrence within 4 months of randomization therefore, no treatment was initiated and study drug was not taken. A total of 756 patients were randomized and took study drug (safety population).

Reporting Groups
  Description
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.
Valacyclovir Patients received Valacyclovir 500 mg capsule twice a day (b.i.d) 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.

Participant Flow:   Overall Study
    Famciclovir     Valacyclovir  
STARTED     579     600  
Received Study Drug (Safety Population)     371     385  
Intent to Treat (ITT) Population     370     381  
COMPLETED     345     359  
NOT COMPLETED     234     241  
Discontinued without taking study drug                 208                 215  
Adverse Event                 1                 1  
Lack of Efficacy                 1                 0  
Protocol Violation                 8                 10  
Withdrawal by Subject                 2                 9  
Lost to Follow-up                 9                 6  
Administrative problems                 4                 0  
Abnormal laboratory value(s)                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
Valacyclovir Patients received Valacyclovir 500 mg capsule twice a day (b.i.d) 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.
Total Total of all reporting groups

Baseline Measures
    Famciclovir     Valacyclovir     Total  
Number of Participants  
[units: participants]
  370     381     751  
Age [1]
[units: years]
Mean ± Standard Deviation
  39.6  ± 11.6     41.7  ± 12.6     40.7  ± 12.2  
Gender  
[units: participants]
     
Female     245     243     488  
Male     125     138     263  
[1] Demographic data is provided for the intent to treat (IIT) population, which included all randomized patients who initiated treatment with (i.e. received any dose of) the study drug, with the intention of treating genital herpes recurrences.



  Outcome Measures
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1.  Primary:   Investigator-assessed Time to Healing of All Non-aborted Genital Herpes Lesions   [ Time Frame: 72 hours after initiation of study medication up to Day 20 ]

2.  Secondary:   Percentage of Participants With Aborted Genital Herpes Lesions   [ Time Frame: 72 hours after initiation of study medication up to Day 20 ]

3.  Secondary:   Investigator-assessed Time to Healing of All (Non-aborted and Aborted) Genital Herpes Lesions   [ Time Frame: 72 hours after initiation of study medication up to Day 20 ]

4.  Secondary:   Time to Resolution of Symptoms Associated With Recurrent Genital Herpes   [ Time Frame: 72 hours after initiation of study medication up to Day 20 ]

5.  Secondary:   Number of Patients With a Second Recurrence of Genital Herpes   [ Time Frame: Up to 6 months after investigator assessed healing of first recurrence of genital herpes ]

6.  Secondary:   Time to a Second Recurrence of Genital Herpes   [ Time Frame: Up to 6 months after investigator assessed healing of first recurrence of genital herpes ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300


No publications provided by Novartis

Publications automatically indexed to this study:

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00306787     History of Changes
Other Study ID Numbers: CFAM810A2308
Study First Received: March 22, 2006
Results First Received: August 20, 2009
Last Updated: June 28, 2011
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Canada: Health Canada
Australia: Department of Health and Ageing Therapeutic Goods Administration