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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: Completed Phase 3 study, sponsored by University of Colorado, Denver.

NCT00865202 is a Phase 3 study that has completed, run by University of Colorado, Denver. The registered enrollment target is 301 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 301 participants
Start Date 2008-12
Est. Completion 2012-12
Phase Phase 3
University of Colorado, Denver

1,283 total trials

What the finished NCT00865202 record still lists

NCT00865202 is an interventional study that assigns participants to a tested intervention. The registered 301 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower).

The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.

NCT00865202 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00865202's enrollment target sits among peer trials

301 1121st of 2000 higher than 879 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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

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Source: ClinicalTrials.gov NCT00865202, the US trial registry maintained by the National Library of Medicine. NCT00865202 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.