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NCT00936000 · ClinicalTrials.gov registry record · Phase 2

Antioxidant Replacement Therapy in Patients With Alcohol Abuse

A Phase 2 study of Alcohol Abuse, sponsored by University of Colorado, Denver.

Completed
Registry status
Phase 2
Development phase
38
Enrollment target
1
Study location

NCT00936000 is a Phase 2 study of Alcohol Abuse that has completed, run by University of Colorado, Denver. The registered enrollment target is 38 participants, below the 712-participant average among 46 other Alcohol Abuse trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00936000, a Phase 2 study of Alcohol Abuse, has completed, sponsored by University of Colorado, Denver.

COMPLETED
Registry status
Phase 2
Development phase
38 participants
Enrollment target
1
Study location

Study Summary

Alcohol is one of the most commonly abused drugs in the world. Up to 40% of medical and surgical patients have alcohol related problems, and alcohol use accounts for more than 10% of U.S. health care costs. In the intensive care unit (ICU), patients with a history of alcohol abuse are common where their rates of mortality and ICU-related morbidity are significantly higher when compared to patients without a history of alcohol abuse. Though ICU patients are a heterogeneous group, Acute Respiratory Distress Syndrome (ARDS), a devastating form of acute lung injury, is one of the more frequent diagnoses among these critically ill patients. In 1996, we made the novel observation that a prior history of chronic alcohol abuse is associated with an increased incidence and severity of ARDS in critically ill patients. In our epidemiological studies of over 570 critically ill patients, 50% of all patients with ARDS have a significant history of chronic alcohol abuse. Since ARDS affects approximately 150,000 patients per year in the United States, and mortality is 40-50% even in previously healthy individuals, alcohol-related ARDS is an enormous national health care problem. We estimate that between 15,000 and 25,000 deaths per year in the United States are associated with alcohol-related ARDS, a number consistent with or even exceeding the number of deaths due to many other alcohol-related diseases such as cirrhosis of the liver and alcohol-related traffic accidents. Further investigations of the association between chronic alcohol abuse and ARDS are needed to develop therapies that improve morbidity and mortality in this important patient population. The clinical syndrome of ARDS is defined as refractory hypoxemia with bilateral infiltrates on chest radiograph in the absence of left atrial hypertension. Pathophysiologically, ARDS is characterized by diffuse alveolar damage, increased pulmonary alveolar-capillary permeability, and the subsequent accumulation of extravascular

Conditions Studied

Interventions

  • DIETARY_SUPPLEMENT Protandim

Study Locations (1)

Colorado

  • University of Colorado Denver - Aurora

Trial Details

FieldValue
Enrollment Target 38 participants
Start Date 2009-06
Est. Completion 2010-09
Phase Phase 2

Sponsor

University of Colorado, Denver

1,283 total trials

What the Registry Record Tells You About NCT00936000

The ClinicalTrials.gov registry entry for NCT00936000 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 712-participant average among 46 other Alcohol Abuse trials with a reported enrollment target (95% lower). The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Alcohol Abuse appearing as the primary indexed condition, and to 1 intervention - of which Protandim is the first listed.

NCT00936000 reports 1 study location spanning 1 distinct geographic area - top geographies include Colorado.

Frequently Asked Questions

What is clinical trial NCT00936000 about?

NCT00936000 is a clinical study titled "Antioxidant Replacement Therapy in Patients With Alcohol Abuse". Alcohol is one of the most commonly abused drugs in the world. Up to 40% of medical and surgical patients have alcohol related problems, and alcohol use accounts for more than 10% of U.S. health care costs. In the intensive care unit (ICU), patients with a history of alcohol abuse are common where t...

What is the current status of trial NCT00936000?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2009-06. Estimated completion is 2010-09.

What conditions does trial NCT00936000 study?

This clinical trial studies the following conditions: Alcohol Abuse.

What interventions are being tested in trial NCT00936000?

The interventions under investigation include: Protandim (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT00936000?

This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00936000 being conducted?

This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.