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NCT00158860 · ClinicalTrials.gov registry record · Phase 4
A Study Comparing Daily Treatment With Valaciclovir To Placebo For Suppression Of Herpes Simplex Virus HSV-2 Genital Herpes In Newly Diagnosed Patients. VALTREX® Tablet is a Trademark of the GlaxoSmithKline Group of Companies.
A Phase 4 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 4
- Development phase
- 384
- Enrollment target
NCT00158860 is a Phase 4 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 384 participants.
The verdict
NCT00158860, a Phase 4 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 384 participants
- Enrollment target
Study Summary
Genital herpes (GH) is a commonly occurring sexually transmitted disease caused by herpes simplex virus (HSV). There are two types of HSV, type 1 (HSV-1) and type 2 (HSV-2); both can cause GH, although the latter is much more likely to produce frequent recurrences of GH lesions. Evidence suggests that there are advantages to using suppressive vs. episodic treatment, which include increased intervals between the pain and discomfort of genital herpes recurrences. Therefore, this study will collect safety and efficacy data on suppressive therapy with valaciclovir in subjects newly diagnosed with HSV-2 genital herpes.
Interventions
- DRUG Placebo
- DRUG Valaciclovir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 384 participants |
| Start Date | 2004-06-21 |
| Est. Completion | 2006-07-26 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00158860
The ClinicalTrials.gov registry entry for NCT00158860 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 384 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00158860 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00158860 about?
NCT00158860 is a clinical study titled "A Study Comparing Daily Treatment With Valaciclovir To Placebo For Suppression Of Herpes Simplex Virus HSV-2 Genital Herpes In Newly Diagnosed Patients. VALTREX® Tablet is a Trademark of the GlaxoSmithKline Group of Companies.". Genital herpes (GH) is a commonly occurring sexually transmitted disease caused by herpes simplex virus (HSV). There are two types of HSV, type 1 (HSV-1) and type 2 (HSV-2); both can cause GH, although the latter is much more likely to produce frequent recurrences of GH lesions. Evidence suggests th...
What is the current status of trial NCT00158860?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 384 participants. The study started on 2004-06-21. Estimated completion is 2006-07-26.
What interventions are being tested in trial NCT00158860?
The interventions under investigation include: Placebo (DRUG), Valaciclovir (DRUG).
Who is sponsoring clinical trial NCT00158860?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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