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NCT00057408 · ClinicalTrials.gov registry record · Phase 2
A Controlled Study of Olanzapine in Children With Autism
A Phase 2 study, sponsored by FDA Office of Orphan Products Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 78
- Enrollment target
NCT00057408 is a Phase 2 study that has completed, run by FDA Office of Orphan Products Development. The registered enrollment target is 78 participants.
The verdict
NCT00057408, a Phase 2 study, has completed, sponsored by FDA Office of Orphan Products Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 78 participants
- Enrollment target
Study Summary
This is a 12-week study which investigates the use of olanzapine to decrease disruptive behaviors sometimes associated with Autism in children, aged 3 to 12 years old. The first six weeks of the study are double-blind and placebo controlled, meaning that patients receive either placebo or olanzapine, and that neither the researchers nor the patients know whether or not they are receiving placebo or olanzapine. In the second six weeks all of the patients receive olanzapine. The purpose in using placebo is that it is otherwise impossible to know how effective the drug is or whether or not the drug causes side effects. Patients treated with placebo can have improvement and can have side effects. In the study patients receive a psychiatric evaluation, physical examination, laboratory tests, and study medication (olanzapine or placebo), free of charge.
Interventions
- DRUG Placebo
- DRUG olanzapine (Zyprexa)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2003-05 |
| Est. Completion | 2005-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00057408
The ClinicalTrials.gov registry entry for NCT00057408 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 78 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is FDA Office of Orphan Products Development, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00057408 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00057408 about?
NCT00057408 is a clinical study titled "A Controlled Study of Olanzapine in Children With Autism". This is a 12-week study which investigates the use of olanzapine to decrease disruptive behaviors sometimes associated with Autism in children, aged 3 to 12 years old. The first six weeks of the study are double-blind and placebo controlled, meaning that patients receive either placebo or olanzapine...
What is the current status of trial NCT00057408?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 78 participants. The study started on 2003-05. Estimated completion is 2005-09.
What interventions are being tested in trial NCT00057408?
The interventions under investigation include: Placebo (DRUG), olanzapine (Zyprexa) (DRUG).
Who is sponsoring clinical trial NCT00057408?
This trial is sponsored by FDA Office of Orphan Products Development, which has 10 total clinical trials registered on ClinicalTrials.gov.
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