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NCT00098059 · ClinicalTrials.gov registry record · Phase 3
Famciclovir Pediatric Formulation in Children 1 to 12 Years of Age With Herpes Simplex Infection
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 74
- Enrollment target
NCT00098059 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 74 participants.
The verdict
NCT00098059, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 74 participants
- Enrollment target
Study Summary
This study will evaluate the safety and blood levels of a new pediatric formulation of Famvir in children 1-12 years of age. In Part A, patients will receive a single dose of famciclovir (12.5 mg/kg) to assess pharmacokinetics (PK) and safety. In Part B, patients will receive multiple doses of famciclovir alone or with concomitant oral anti-herpes therapy to assess safety and tolerability. Part B will start only after PK data from Part A had been analyzed.
Interventions
- DRUG Famciclovir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2005-02 |
| Est. Completion | 2007-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00098059
The ClinicalTrials.gov registry entry for NCT00098059 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 74 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Famciclovir is the first listed.
NCT00098059 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00098059 about?
NCT00098059 is a clinical study titled "Famciclovir Pediatric Formulation in Children 1 to 12 Years of Age With Herpes Simplex Infection". This study will evaluate the safety and blood levels of a new pediatric formulation of Famvir in children 1-12 years of age. In Part A, patients will receive a single dose of famciclovir (12.5 mg/kg) to assess pharmacokinetics (PK) and safety. In Part B, patients will receive multiple doses of famci...
What is the current status of trial NCT00098059?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 74 participants. The study started on 2005-02. Estimated completion is 2007-12.
What interventions are being tested in trial NCT00098059?
The interventions under investigation include: Famciclovir (DRUG).
Who is sponsoring clinical trial NCT00098059?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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