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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: Completed Phase 4 study of Pain and Alzheimer Disease, sponsored by VA Office of Research and Development.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Pain intensity observational assessment for persons with severe dementia. Higher scores indicate more pain/discomfort. Scale range is 0-10.
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 |
What the finished NCT00385684 record still lists
NCT00385684 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 304-participant average among 374 other Pain trials with a reported enrollment target (96% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT00385684's enrollment target sits among peer trials
11 362nd of 374 higher than 10 of 374 other Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pain 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.
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