Patient-initiated Episodic Treatment of Recurrent Genital Herpes in Black Patients
NCT ID: NCT00477334
Last Updated: 2011-03-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
463 participants
INTERVENTIONAL
2007-06-30
2009-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
Famciclovir 1000 mg; twice a day for one day.
Famciclovir
oral; two 500 mg tablets twice a day; single day treatment
2
Placebo; twice a day for one day.
Placebo
oral; two tablets twice a day; single day treatment
Interventions
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Famciclovir
oral; two 500 mg tablets twice a day; single day treatment
Placebo
oral; two tablets twice a day; single day treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* History of recurrent genital herpes with at least 4 recurrences in preceding 12 months or in preceding 12 months prior to using suppressive antiviral therapy
* Documented herpes simplex virus type 2 (HSV-2) seropositivity
* Willingness to discontinue suppressive therapy during study, if applicable
* Willingness and ability to comply with the study protocol
Exclusion Criteria
* Women of childbearing potential not using accepted methods of contraception
* Hypersensitivity to famciclovir or drugs with similar chemical structures
* Renal dysfunction
* Known or suspected to have decompensated liver disease
* Known to have gastrointestinal malabsorption
* Known to be immunocompromised
* Known to be hypersensitive to ingredients in study medication
18 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Responsible Party
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Novartis
Principal Investigators
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Dalu Mohammed, Dr
Role: PRINCIPAL_INVESTIGATOR
Clayton Research Institute
Locations
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Providence Clinical Research
Burbank, California, United States
Alia Clinical Research, INC
Huntington Park, California, United States
Dermatology Research Associates
Los Angeles, California, United States
The Conant Foundation Quest Diagnostics
San Francisco, California, United States
Medical Research Centers of South Florida, Inc.
Hollywood, Florida, United States
First Coast Primary Care Minority Physicians Research Alliance
Jacksonville, Florida, United States
AppleMed Research Inc.
Miami, Florida, United States
International Research Associates, LLC
Miami, Florida, United States
Segal Institute for Clinical Research Heathcare Clinical Data, Inc
North Miami, Florida, United States
Perimeter Institute for Clinical Research Inc. ("PICR")
Atlanta, Georgia, United States
Medical College of Georgia Hospital and Clinics
Augusta, Georgia, United States
Soapstone Center for Clinical Research
Decatur, Georgia, United States
Mount Vernon Clinical Research, LLC
Sandy Springs, Georgia, United States
Clinical Trials Management LLC
Covington, Louisiana, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, United States
Omni Fertility and Laser Institute
Shreveport, Louisiana, United States
International Research Center
Towson, Maryland, United States
Miray Medical Center
Brockton, Massachusetts, United States
Pearl Medical Group, PLLC
Southfield, Michigan, United States
Dr. Mohammed
St Louis, Missouri, United States
Nevada Alliance Against Diabetes
Las Vegas, Nevada, United States
Metrolina Internal Medicine Internal Medicine Research
Charlotte, North Carolina, United States
Peters Medical Research
High Point, North Carolina, United States
UNC Clinical Research
Raleigh, North Carolina, United States
Hawthorne Medical Research, Inc.
Winston-Salem, North Carolina, United States
Planned Parenthood of Arkansas and Eastern Oklahoma
Tulsa, Oklahoma, United States
The Clinical Trial Center, LLC
Jenkintown, Pennsylvania, United States
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States
Women's Care Center, PLC: Research Memphis Associates
Memphis, Tennessee, United States
Private Practice
Fort Worth, Texas, United States
R/D Clinical Research, Inc
Houston, Texas, United States
Sun Research Institute
San Antonio, Texas, United States
Millennium Clinical Trials, LLC
Arlington, Virginia, United States
Josha Research
Bloemfontein, , South Africa
Prime Cure Medicentre
Durban, , South Africa
Umkomaas Clinical Research Site
eMkhomazi, , South Africa
Drs. Essack and Mitha
Johannesburg, , South Africa
Medunsa Clinical Research Unit (MeCRU)
Medunsa, , South Africa
Bertoni Mercy Clinic
Mmakau Village GA Rankuwa, , South Africa
Global Clinical Trials
Port Elizabeth, , South Africa
Eastmed Clinical Trial Centre/Eastmed Medical Centre
Pretoria, , South Africa
Setshaba Research Centre
Shoshanguve, , South Africa
Drs. AE and QE Bhorat
Soweto, , South Africa
Countries
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References
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Leone P, Abudalu M, Mitha E, Gani M, Zhou W, Hamed K. One-day famciclovir vs. placebo in patient-initiated episodic treatment of recurrent genital herpes in immunocompetent Black patients. Curr Med Res Opin. 2010 Mar;26(3):653-61. doi: 10.1185/03007990903554471.
Related Links
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Click here for more information on this study
Other Identifiers
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CFAM810A2310
Identifier Type: -
Identifier Source: org_study_id
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