Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00109395 · ClinicalTrials.gov registry record · Phase 2
Lorazepam Sedation for Critically Ill Children
A Phase 2 study, sponsored by The Emmes Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 179
- Enrollment target
NCT00109395 is a Phase 2 study that has completed, run by The Emmes Company. The registered enrollment target is 179 participants.
The verdict
NCT00109395, a Phase 2 study, has completed, sponsored by The Emmes Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 179 participants
- Enrollment target
Study Summary
This clinical trial is being performed under the Best Pharmaceuticals for Children Act, signed into law in 2002 in order to improve pediatric labeling for off-patent drugs. The purpose of this study is to make sure that lorazepam, when given to children who are very sick in the Intensive Care Unit and who are on a breathing machine, is safe and works as well as a drug called midazolam. Midazolam is already approved by the FDA for this use, but lorazepam is not, even though both drugs are commonly used for sedation.
Interventions
- DRUG Midazolam
- DRUG Lorazepam
- DRUG Lorazepam CI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 179 participants |
| Start Date | 2004-09 |
| Est. Completion | 2007-09 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00109395
The ClinicalTrials.gov registry entry for NCT00109395 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 179 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Emmes Company, which has 11 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Midazolam is the first listed.
NCT00109395 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00109395 about?
NCT00109395 is a clinical study titled "Lorazepam Sedation for Critically Ill Children". This clinical trial is being performed under the Best Pharmaceuticals for Children Act, signed into law in 2002 in order to improve pediatric labeling for off-patent drugs. The purpose of this study is to make sure that lorazepam, when given to children who are very sick in the Intensive Care Unit a...
What is the current status of trial NCT00109395?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 179 participants. The study started on 2004-09. Estimated completion is 2007-09.
What interventions are being tested in trial NCT00109395?
The interventions under investigation include: Midazolam (DRUG), Lorazepam (DRUG), Lorazepam CI (DRUG).
Who is sponsoring clinical trial NCT00109395?
This trial is sponsored by The Emmes Company, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.