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NCT00878072 · ClinicalTrials.gov registry record · Phase 2
Safety and Pharmacokinetics of Famciclovir Single 1500 mg Dose in Adolescents With Recurrent Herpes Labialis
A Phase 2 study of Herpes Labialis, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 53
- Enrollment target
- 12
- Study locations
NCT00878072: Completed Phase 2 study of Herpes Labialis, sponsored by Novartis Pharmaceuticals.
NCT00878072 is a Phase 2 study of Herpes Labialis that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 53 participants, below the 1,054-participant average among 6 other Herpes Labialis trials with a reported enrollment target (95% lower). The trial reports 12 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00878072, a Phase 2 study of Herpes Labialis, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 53 participants
- Enrollment target
- 12
- Study locations
Study 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
Primary Outcome
AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or
Conditions Studied
Interventions
- DRUG Famciclovir
Study Locations (12)
Texas
- Texas Children's Hospital - Houston
- R/D Clinical Research, Inc - Lake Jackson
- R/D Clinical Research - Lake Jackson
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
- University Hospitals Case Medical Center - Cleveland
California
- Women's Health Care at Frost Street - San Diego
Illinois
- Children's Memorial Hospital - Chicago
Indiana
- Medisphere Medical Research Center, LLC - Evansville
Missouri
- Clayton Medical Research - St Louis
New York
- Rochester Clinical Research, Inc. - Rochester
Oregon
- Westover Heights Clinic - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2009-03-25 |
| Est. Completion | 2010-06-02 |
| Phase | Phase 2 |
What the finished NCT00878072 record still lists
NCT00878072 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 1,054-participant average among 6 other Herpes Labialis trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Herpes Labialis appearing as the primary indexed condition, and to 1 intervention - of which Famciclovir is the first listed.
NCT00878072 lists 12 locations in 9 states (Texas, Ohio, California).
Frequently Asked Questions
What is clinical trial NCT00878072 about?
NCT00878072 is a clinical study titled "Safety and Pharmacokinetics of Famciclovir Single 1500 mg Dose in Adolescents With Recurrent Herpes Labialis". 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
What is the current status of trial NCT00878072?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 53 participants. The study started on 2009-03-25. Estimated completion is 2010-06-02.
What conditions does trial NCT00878072 study?
This clinical trial studies the following conditions: Herpes Labialis.
What interventions are being tested in trial NCT00878072?
The interventions under investigation include: Famciclovir (DRUG).
Who is sponsoring clinical trial NCT00878072?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00878072 being conducted?
This trial has 12 study locations across California, Illinois, Indiana, Missouri, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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