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: Completed Phase 2 study, sponsored by The Emmes Company.
NCT00109395 is a Phase 2 study that has completed, run by The Emmes Company. The registered enrollment target is 179 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Duration of study participation
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 |
What the finished NCT00109395 record still lists
NCT00109395 is an interventional study that assigns participants to a tested intervention. The registered 179 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% higher).
The record links to 0 conditions, and to 3 interventions - of which Midazolam is the first listed.
NCT00109395 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT00109395's enrollment target sits among peer trials
179 391st of 2000 higher than 1,610 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06581198 · 179 participants · Phase 2
A Study of Rapcabtagene Autoleucel in Active, Refractory Systemic Lupus Erythematosus (SLE) or Lupus Nephritis (LN) Patients (AUTOGRAPH - SLE/LN)
- NCT07356323 · 179 participants · NA
A Prospective, Single-arm, Trial to Determine Contamination Rates When Using an Antibacterial Incise Drape During Orthopedic Surgery
- NCT01558804 · 180 participants
GRoup A StrePtococcus
- NCT02932176 · 180 participants
Machine Learning for Handheld Vascular Studies
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia