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NCT00297206 · ClinicalTrials.gov registry record · Phase 1
A Safety And Tolerability Study Of Valaciclovir Oral Suspension In Infants And Children
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
NCT00297206 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 36 participants.
The verdict
NCT00297206, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
Study Summary
Limited data are available on valaciclovir use in children and valaciclovir is not currently approved for use in pediatrics. The marketed formulation of valaciclovir is not ideal for use in pre-adolescent patients who may have trouble swallowing solid oral dosage forms. An extemporaneous suspension formulation of valaciclovir has been developed to expedite the provision of benefits to children similar to those from administration of valaciclovir solid formulations in adults.
Interventions
- DRUG Valaciclovir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2003-01-25 |
| Est. Completion | 2007-02-28 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00297206
The ClinicalTrials.gov registry entry for NCT00297206 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 36 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 1 intervention - of which Valaciclovir is the first listed.
NCT00297206 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00297206 about?
NCT00297206 is a clinical study titled "A Safety And Tolerability Study Of Valaciclovir Oral Suspension In Infants And Children". Limited data are available on valaciclovir use in children and valaciclovir is not currently approved for use in pediatrics. The marketed formulation of valaciclovir is not ideal for use in pre-adolescent patients who may have trouble swallowing solid oral dosage forms. An extemporaneous suspension ...
What is the current status of trial NCT00297206?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2003-01-25. Estimated completion is 2007-02-28.
What interventions are being tested in trial NCT00297206?
The interventions under investigation include: Valaciclovir (DRUG).
Who is sponsoring clinical trial NCT00297206?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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