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NCT00385684 · ClinicalTrials.gov registry record · Phase 4
Low-Dose Opiate Therapy for Discomfort in Dementia (L-DOT)
A Phase 4 study of Pain and Alzheimer Disease, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 4
- Development phase
- 11
- Enrollment target
- 3
- Study locations
NCT00385684 is a Phase 4 study of Pain and Alzheimer Disease that has completed, run by VA Office of Research and Development. The registered enrollment target is 11 participants, below the 304-participant average among 374 other Pain trials with a reported enrollment target (96% lower). The trial reports 3 study locations across 1 state.
The verdict
NCT00385684, a Phase 4 study of Pain and Alzheimer Disease, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 11 participants
- Enrollment target
- 3
- Study locations
Study Summary
The purpose of this study was to determine whether a low dose an opiate pain medication is effective for the treatment of discomfort in patients with advanced dementia. The study medication was also known as Lortab and contained both a narcotic pain medication and acetaminophen (the same pain medication as contained in Tylenol). This study was an eight-week long clinical trial for discomfort among veterans with advanced dementia who were admitted to a Nursing Home Care Unit (NHCU) at the Tuscaloosa VA Medical Center.
Conditions Studied
Interventions
- DRUG hydrocodone/APAP w placebo PRN
- DRUG hydrocodone/APAP
- DRUG placebo with hydrocodone/APAP PRN
Study Locations (3)
Alabama
- Tuscaloosa VA Medical Center - Tuscaloosa
- Tuscaloosa Veterans Affairs Medical Center - Tuscaloosa
- VA Medical Center, Tuscaloosa - Tuscaloosa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2007-10 |
| Est. Completion | 2014-06 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00385684
The ClinicalTrials.gov registry entry for NCT00385684 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 304-participant average among 374 other Pain trials with a reported enrollment target (96% lower). The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Pain appearing as the primary indexed condition, and to 3 interventions - of which hydrocodone/APAP w placebo PRN is the first listed.
NCT00385684 reports 3 study locations spanning 1 distinct geographic area - top geographies include Alabama.
Frequently Asked Questions
What is clinical trial NCT00385684 about?
NCT00385684 is a clinical study titled "Low-Dose Opiate Therapy for Discomfort in Dementia (L-DOT)". The purpose of this study was to determine whether a low dose an opiate pain medication is effective for the treatment of discomfort in patients with advanced dementia. The study medication was also known as Lortab and contained both a narcotic pain medication and acetaminophen (the same pain medica...
What is the current status of trial NCT00385684?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 11 participants. The study started on 2007-10. Estimated completion is 2014-06.
What conditions does trial NCT00385684 study?
This clinical trial studies the following conditions: Pain, Alzheimer Disease, Dementia, Dementia, Vascular.
What interventions are being tested in trial NCT00385684?
The interventions under investigation include: hydrocodone/APAP w placebo PRN (DRUG), hydrocodone/APAP (DRUG), placebo with hydrocodone/APAP PRN (DRUG).
Who is sponsoring clinical trial NCT00385684?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00385684 being conducted?
This trial has 3 study locations across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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.