Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED Phase 2

Safety and Pharmacokinetics of Famciclovir Single 1500 mg Dose in Adolescents With Recurrent Herpes Labialis

NCT00878072 · View on ClinicalTrials.gov ↗

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

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

FieldValue
Enrollment Target 53 participants
Start Date 2009-03-25
Est. Completion 2010-06-02
Phase Phase 2

Sponsor

Novartis Pharmaceuticals

792 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00878072

The ClinicalTrials.gov registry entry for NCT00878072 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 53 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 792 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00878072 reports 12 study locations spanning 9 distinct geographic areas — top geographies include Texas, Ohio, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00878072?

The interventions under investigation include: Famciclovir (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00878072?

This trial is sponsored by Novartis Pharmaceuticals, which has 792 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial