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NCT00769314 · ClinicalTrials.gov registry record · Phase 3
Phase 3 Clinical Study for the Treatment of Cold Sore
A Phase 3 study of Herpes Labialis, sponsored by Valerio Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,727
- Enrollment target
- 20
- Study locations
NCT00769314: Completed Phase 3 study of Herpes Labialis, sponsored by Valerio Therapeutics.
NCT00769314 is a Phase 3 study of Herpes Labialis that has completed, run by Valerio Therapeutics. The registered enrollment target is 1,727 participants, above the 775-participant average among 6 other Herpes Labialis trials with a reported enrollment target (123% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00769314, a Phase 3 study of Herpes Labialis, has completed, sponsored by Valerio Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,727 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Healing was defined as the loss of crust (erythema may be present) as assessed by the investigator. TTH was the time from treatment initiation to healing as defined above and was assessed from the time of treatment initiation through Day 14. The primary vesicular lesion was the first developed lesion located on the lip and was not to have extended more than 1 cm outside the lip.
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
| Field | Value |
|---|---|
| Enrollment Target | 1,727 participants |
| Start Date | 2007-05 |
| Est. Completion | 2009-08 |
| Phase | Phase 3 |
What the finished NCT00769314 record still lists
NCT00769314 is an interventional study that assigns participants to a tested intervention. Its 1,727 participants enrollment target places it among the larger protocols in the corpus, above the 775-participant average among 6 other Herpes Labialis trials with a reported enrollment target (123% higher).
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.
NCT00769314 names 20 study sites across 8 states, led by Other, Arizona, New York.
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.
What interventions are being tested in trial NCT00769314?
The interventions under investigation include: Placebo (DRUG), Acyclovir Lauriad (DRUG).
Who is sponsoring clinical trial NCT00769314?
This trial is sponsored by Valerio Therapeutics, which has 13 total clinical trials registered on ClinicalTrials.gov.
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.
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