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NCT00865202 · ClinicalTrials.gov registry record · Phase 3
A Placebo Controlled Trial Of L-Tryptophan In Post-Operative Delirium
A Phase 3 study, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- Phase 3
- Development phase
- 301
- Enrollment target
NCT00865202 is a Phase 3 study that has completed, run by University of Colorado, Denver. The registered enrollment target is 301 participants.
The verdict
NCT00865202, a Phase 3 study, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 301 participants
- Enrollment target
Study Summary
Post-operative delirium is a common and deleterious complication in elderly patients. The investigators have previously found lower levels of serum tryptophan in post-operative elderly patients who developed delirium in comparison to post-operative elderly patients who did not develop delirium. The investigators hypothesize that post-operative supplementation of L-tryptophan will reduce the duration and incidence of post-operative delirium. This study is a double-blinded placebo controlled trial of L-tryptophan supplementation in post-operative ICU patients 60 years and older. The primary outcome measure is the comparison of duration of post-operative delirium in subjects who receive L-tryptophan supplementation versus a similar appearing control.
Interventions
- DRUG placebo
- DRUG L-tryptophan supplementation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 301 participants |
| Start Date | 2008-12 |
| Est. Completion | 2012-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00865202
The ClinicalTrials.gov registry entry for NCT00865202 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 301 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00865202 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00865202 about?
NCT00865202 is a clinical study titled "A Placebo Controlled Trial Of L-Tryptophan In Post-Operative Delirium". Post-operative delirium is a common and deleterious complication in elderly patients. The investigators have previously found lower levels of serum tryptophan in post-operative elderly patients who developed delirium in comparison to post-operative elderly patients who did not develop delirium. The ...
What is the current status of trial NCT00865202?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 301 participants. The study started on 2008-12. Estimated completion is 2012-12.
What interventions are being tested in trial NCT00865202?
The interventions under investigation include: placebo (DRUG), L-tryptophan supplementation (DRUG).
Who is sponsoring clinical trial NCT00865202?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
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