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COMPLETED Phase 3

Phase 3 Clinical Study for the Treatment of Cold Sore

NCT00769314 · View on ClinicalTrials.gov ↗

Study Summary

To demonstrate the efficacy of a single dose of acyclovir Lauriad® 50mg muco-adhesive buccal tablet versus a single dose of matching placebo on the primary vesicular lesion of cold sore.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Acyclovir Lauriad

Study Locations (20)

Other

  • Taylor Square Private Clinic — Sydney
  • Central Brunswick Medical Centre — Sydney
  • General Teaching Hospital, Dep. Of Dermatology — Opava
  • U zastavky 16 — Opava
  • Central military hospital Dept. of Dermatology — Prague
  • University Hospital Bulovka 3rd Clinic of Inf. Diseases — Prague
  • University Hospital Bulovka Dept. of Dermatology — Prague
  • Hôpital St Jacques Service de Dermatologie — Besançon
  • Private Practice — Martigues
  • Hopital Fournier, Service de dermatologie — Nancy

Arizona

  • Radiant Research, Inc., — Scottsdale
  • Radiant Research, Inc., — Tucson

New York

  • Rochester Clinical Research, Inc., — Rochester
  • Stony Brook University Medical Center — Stony Brook

Texas

  • Center for Clinical Studies — Houston
  • Center for Clinical Studies, Ltd., LLP. — Houston

California

  • Dermatology Private Practice — San Francisco

Colorado

  • Front Range Clinical Research — Wheat Ridge

Idaho

  • St. Luke's Family Health, — Meridian

Missouri

  • Clinvest, a Division of Banyan Group, Inc., — Springfield

Trial Details

FieldValue
Enrollment Target 1,727 participants
Start Date 2007-05
Est. Completion 2009-08
Phase Phase 3

Sponsor

Valerio Therapeutics

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00769314

The ClinicalTrials.gov registry entry for NCT00769314 describes a study currently listed as completed. It is categorized as Phase 3, 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 1,727 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Valerio Therapeutics, which has 1 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 2 interventions — of which Placebo 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: NCT00769314 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Other, Arizona, New York. 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 NCT00769314 about?

NCT00769314 is a clinical study titled "Phase 3 Clinical Study for the Treatment of Cold Sore". To demonstrate the efficacy of a single dose of acyclovir Lauriad® 50mg muco-adhesive buccal tablet versus a single dose of matching placebo on the primary vesicular lesion of cold sore.

What is the current status of trial NCT00769314?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,727 participants. The study started on 2007-05. Estimated completion is 2009-08.

What conditions does trial NCT00769314 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 NCT00769314?

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

Who is sponsoring clinical trial NCT00769314?

This trial is sponsored by Valerio Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00769314 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Idaho, Missouri. 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