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NCT00116844 · ClinicalTrials.gov registry record · Phase 4
VALTREX Once Daily For Viral Shedding In Herpes Simplex Virus 2 (HSV-2) Seropositive Subjects. VALTREX® Tablet is a Trademark of GlaxoSmithKline Group of Companies.
A Phase 4 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 4
- Development phase
- 73
- Enrollment target
NCT00116844: Completed Phase 4 study, sponsored by GlaxoSmithKline.
NCT00116844 is a Phase 4 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 73 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00116844, a Phase 4 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 73 participants
- Enrollment target
Study Summary
Eligible subjects will be randomized to receive VALTREX® tablet 1g or placebo once daily for 60 days in a two-way crossover study with a washout period of 7 days between treatment periods.
Primary Outcome
Percent of subclinical days with HSV-2 shedding was defined for each participant as the percent of subclinical days with PCR data for which HSV-2 shedding was detected by a positive PCR result, that is, the number of subclinical days with HSV-2 PCR shedding divided by total number of subclinical days with PCR data, multiplied by 100. For each participant, each study day was classified by PCR as 'shedding' or 'no shedding'; additionally each day was classified as 'clinical' (presence of genital l
Interventions
- DRUG Placebo
- DRUG Valaciclovir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 73 participants |
| Start Date | 2005-03-29 |
| Est. Completion | 2006-01-10 |
| Phase | Phase 4 |
What the finished NCT00116844 record still lists
NCT00116844 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 73 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00116844 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00116844 about?
NCT00116844 is a clinical study titled "VALTREX Once Daily For Viral Shedding In Herpes Simplex Virus 2 (HSV-2) Seropositive Subjects. VALTREX® Tablet is a Trademark of GlaxoSmithKline Group of Companies.". Eligible subjects will be randomized to receive VALTREX® tablet 1g or placebo once daily for 60 days in a two-way crossover study with a washout period of 7 days between treatment periods.
What is the current status of trial NCT00116844?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 73 participants. The study started on 2005-03-29. Estimated completion is 2006-01-10.
What interventions are being tested in trial NCT00116844?
The interventions under investigation include: Placebo (DRUG), Valaciclovir (DRUG).
Who is sponsoring clinical trial NCT00116844?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00116844's enrollment target sits among peer trials
73 1033rd of 2000 higher than 966 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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