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NCT00306787 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Famciclovir 1-day Treatment Compared to 3-day Treatment With Valacyclovir in Adults With Recurrent Genital Herpes
A Phase 3 study of Genital Herpes, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,179
- Enrollment target
- 20
- Study locations
NCT00306787: Completed Phase 3 study of Genital Herpes, sponsored by Novartis Pharmaceuticals.
NCT00306787 is a Phase 3 study of Genital Herpes that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 1,179 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (53% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00306787, a Phase 3 study of Genital Herpes, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,179 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will assess the safety and efficacy of one-day famciclovir (1000 mg twice a day (b.i.d)) in reducing the duration of genital herpes lesions and the associated symptoms compared to three-day treatment with valacyclovir (500 mg capsule b.i.d).
Primary Outcome
Time to healing of all non-aborted genital herpes lesions was defined as the time from the first dose of study drug taken no earlier than the recurrence of genital herpes to the investigator-assessed time of healing (i.e. loss of all crusts and re-epithelialization of the lesions; erythema could have been present). Non-aborted lesions are lesions which underwent vesicle, ulcer/soft crust, and/or hard crust formation and required re-epithelialization for healing. The median time was estimated usi
Conditions Studied
Interventions
- DRUG Valacyclovir
- DRUG Famciclovir
- DRUG Placebo matching famciclovir
- DRUG Placebo matching valacyclovir
Study Locations (20)
California
- Providence Clinical Research - Burbank
- Dermatology Research Associates - Los Angeles
- Sacramento Research Medical Group - Sacramento
- North California Research Corp. - Sacramento
- Medical Center for Clinical Research - San Diego
- Conant Research - San Francisco
Florida
- Visions Clinical Research - Boynton Beach
- Women's Medical Research Group, LLC - Clearwater
- International Research Association LLC - Miami
- Orlando Clinical Research Ctr. - Orlando
- Avancia Research - Pembroke Pines
Arizona
- Novartis Investigative Site - Chandler
- Women's Health Research - Phoenix
- Quality of Life Medical & Research Center, LLC - Tucson
Arkansas
- Burke Pharmaceutical Research - Hot Springs
- NEA Women's Clinic - Jonesboro
- The Woman's Clinic - Little Rock
Colorado
- Barbara Davis Center - Denver
- Cohen & Womack, P.C. - Lakewood
Alabama
- University of Alabama at Birmingham - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,179 participants |
| Start Date | 2006-03 |
| Est. Completion | 2008-02 |
| Phase | Phase 3 |
What the finished NCT00306787 record still lists
NCT00306787 is an interventional study that assigns participants to a tested intervention. Its 1,179 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (53% higher).
The record links to 1 condition, with Genital Herpes appearing as the primary indexed condition, and to 4 interventions - of which Valacyclovir is the first listed.
NCT00306787 names 20 study sites across 6 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT00306787 about?
NCT00306787 is a clinical study titled "Efficacy and Safety of Famciclovir 1-day Treatment Compared to 3-day Treatment With Valacyclovir in Adults With Recurrent Genital Herpes". This study will assess the safety and efficacy of one-day famciclovir (1000 mg twice a day (b.i.d)) in reducing the duration of genital herpes lesions and the associated symptoms compared to three-day treatment with valacyclovir (500 mg capsule b.i.d).
What is the current status of trial NCT00306787?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,179 participants. The study started on 2006-03. Estimated completion is 2008-02.
What conditions does trial NCT00306787 study?
This clinical trial studies the following conditions: Genital Herpes.
What interventions are being tested in trial NCT00306787?
The interventions under investigation include: Valacyclovir (DRUG), Famciclovir (DRUG), Placebo matching famciclovir (DRUG), Placebo matching valacyclovir (DRUG).
Who is sponsoring clinical trial NCT00306787?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00306787 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Genital Herpes
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00306787's enrollment target sits among peer trials
1,179 235th of 2000 higher than 1,766 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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