At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 53 enrolled
Drug / intervention
Famciclovirdrug
Likely dose
Famciclovir 1500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Open-label, Single-arm Study to Evaluate the Safety and Pharmacokinetics of Famciclovir Single 1500 mg Dose in Adolescents With Recurrent Herpes Labialis
In Brief
A Phase 3 clinical trial evaluating Famciclovir for Herpes Labialis. Completed, enrolled 53 participants across 12 sites.
Detailed Summary
This study will assess the safety, tolerability of a single 1500 mg dose of famciclovir in 50 adolescents with recurrent herpes labialis. Eight of the 50 adolescents will also participate in the pharmacokinetics (PK) assessment of famciclovir single 1500 mg dose
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHerpes Labialis
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2009
First PostedApr 2009
Primary CompletionJun 2010
TodayJul 2026
First PostedApr 8, 2009
Enrollment StartMar 25, 2009
Primary CompletionJun 2, 2010
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 17.2 years ago
Interventions
Famciclovirdrug
Famciclovir 1500 mg (3 x 500 mg tablets) oral as a single dose.