Safety and Pharmacokinetics of Famciclovir Single 1500 mg Dose in Adolescents With Recurrent Herpes Labialis
NCT ID: NCT00878072
Last Updated: 2021-06-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
53 participants
INTERVENTIONAL
2009-03-25
2010-06-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Famciclovir
Famciclovir
Famciclovir 1500 mg (3 x 500 mg tablets) oral as a single dose.
Interventions
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Famciclovir
Famciclovir 1500 mg (3 x 500 mg tablets) oral as a single dose.
Eligibility Criteria
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Inclusion Criteria
* General good health with a documented history typical for recurrent herpes labialis
* Prodromal symptoms or active lesions suggestive of a recurrent episode of herpes labialis (i.e. having had cold sores in the past) , with onset not exceeding 24 hours until the time of study drug administration
* Adolescents participating in Pharmacokinetics (PK) part of the study may be enrolled without an active herpes labialis recurrence or with onset of signs/symptoms of a recurrent herpes labialis episode longer than 24 hours before study drug administration, All adolescents participating in the pharmacokinetics assessments must fast for at least 8 hours prior to Visit 1 and be willing to fast for an additional 2 hours after study drug administration
Exclusion Criteria
* History of hypersensitivity to famciclovir or penciclovir
* Inability to swallow tablets
* Body weight less than 40 Killograms (kg)
* History of malabsorption, unless a condition like celiac disease is stable and well controlled, previous gastrointestinal surgery or radiation therapy that could affect drug absorption or metabolism, or any condition that could interfere with drug absorption, distribution, metabolism, or excretion
* Known renal insufficiency (calculated creatinine clearance \<60 \[Milliliters/Minutes\] mL/min)
* Known severe hepatic impairment (Child-Pugh Class C)
* Significant skin disease such as atopic dermatitis or eczema that would interfere with assessment of oral/labial lesions
* Known to be immunocompromised or are receiving systemic or using topical immunosuppressive agents (including corticosteroids, tacrolimus and picrolimus) within 30 days of enrollment
* Concomitant use of probenecid
* Pregnant or nursing (lactating) females
* Females of child-bearing potential, UNLESS they are using two birth control methods. The two methods can be a double barrier method or a barrier method plus a hormonal method.
12 Years
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Women's Health Care at Frost Street
San Diego, California, United States
Children's Memorial Hospital
Chicago, Illinois, United States
Medisphere Medical Research Center, LLC
Evansville, Indiana, United States
Clayton Medical Research
St Louis, Missouri, United States
Rochester Clinical Research, Inc.
Rochester, New York, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
University Hospitals Case Medical Center
Cleveland, Ohio, United States
Westover Heights Clinic
Portland, Oregon, United States
Primary Physicians Research, Inc
Pittsburgh, Pennsylvania, United States
Texas Children's Hospital
Houston, Texas, United States
R/D Clinical Research, Inc
Lake Jackson, Texas, United States
R/D Clinical Research
Lake Jackson, Texas, United States
Countries
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References
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Block SL, Yogev R, Waldmeier F, Hamed K. Safety and pharmacokinetics of a single 1500-mg dose of famciclovir in adolescents with recurrent herpes labialis. Pediatr Infect Dis J. 2011 Jun;30(6):525-8. doi: 10.1097/INF.0b013e3182067cee.
Related Links
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NovartisClinicalTrials.com: pre-screening for this trial, view of a list of trials and participating study centers
Adolescent Cold Sores Clinical Trial
Other Identifiers
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CFAM810B2305
Identifier Type: -
Identifier Source: org_study_id
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