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NCT00621478 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety Study Comparing Lorazepam and Diazepam for Children in the Emergency Department With Seizures (Status 2)
A Phase 2 study, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- Completed
- Registry status
- Phase 2
- Development phase
- 259
- Enrollment target
NCT00621478 is a Phase 2 study that has completed, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 259 participants.
The verdict
NCT00621478, a Phase 2 study, has completed, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 259 participants
- Enrollment target
Study Summary
Children with seizures are frequently seen in the emergency department. The drug lorazepam, which is commonly used, is not labeled by the US Food and Drug Administration for children for this use. The FDA, under the Best Pharmaceuticals for Children Act, has requested that a study comparing diazepam, a drug that is labeled by the FDA for this indication, with lorazepam be performed. The study will show whether one drug is more effective and safe than the other.
Interventions
- DRUG lorazepam or diazepam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 259 participants |
| Start Date | 2008-02 |
| Est. Completion | 2012-05 |
| Phase | Phase 2 |
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)305 total trials
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00621478
The ClinicalTrials.gov registry entry for NCT00621478 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 259 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which lorazepam or diazepam is the first listed.
NCT00621478 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00621478 about?
NCT00621478 is a clinical study titled "Efficacy and Safety Study Comparing Lorazepam and Diazepam for Children in the Emergency Department With Seizures (Status 2)". Children with seizures are frequently seen in the emergency department. The drug lorazepam, which is commonly used, is not labeled by the US Food and Drug Administration for children for this use. The FDA, under the Best Pharmaceuticals for Children Act, has requested that a study comparing diazepam...
What is the current status of trial NCT00621478?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 259 participants. The study started on 2008-02. Estimated completion is 2012-05.
What interventions are being tested in trial NCT00621478?
The interventions under investigation include: lorazepam or diazepam (DRUG).
Who is sponsoring clinical trial NCT00621478?
This trial is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total clinical trials registered on ClinicalTrials.gov.
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