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NCT00586196 · ClinicalTrials.gov registry record · Phase 2
Supporting the Health of Adults Undergoing Orthopedic Surgery During the Recovery Period
A Phase 2 study, sponsored by Beth Israel Deaconess Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 16
- Enrollment target
NCT00586196 is a Phase 2 study that has completed, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 16 participants.
The verdict
NCT00586196, a Phase 2 study, has completed, sponsored by Beth Israel Deaconess Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 16 participants
- Enrollment target
Study Summary
Delirium (acute confusion) is a highly prevalent condition among hospitalized elders with substantial morbidity within the hospital and beyond. Particular patient populations are at high risk for poor outcomes after an episode of delirium. Patients with hip and other long bone fractures are at increased risk of developing delirium (acute confusion) which impedes functional recovery. This is a pilot study to test the tolerability and efficacy of donepezil, a cholinesterase inhibitor medication used commonly in persons with dementia, for the prevention of new or worsening delirium in aged hip and other long-bone fracture patients. Additional purposes involve gathering a small amount of patients' serum to better understand the pathophysiology of delirium in this population. The purposes of this pilot study are to determine: 1) the safety and tolerability a cholinesterase inhibitor medication) in aged hip and long bone fracture patients, 2) To obtain estimates of subject accrual and preliminary estimates of effect size on the development of new delirium symptoms to allow for planning of a larger, definitive trial, 3) To better understand the underlying causes of delirium by examining whether a measure of blood anticholinergic activity relates to the incidence and persistence of delirium symptoms, and 4) To explore the interaction between anticholinergic activity, donepezil therapy, and delirium symptoms.
Interventions
- DRUG Placebo
- DRUG donepezil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2007-01 |
| Est. Completion | 2013-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00586196
The ClinicalTrials.gov registry entry for NCT00586196 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Beth Israel Deaconess Medical Center, which has 488 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00586196 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00586196 about?
NCT00586196 is a clinical study titled "Supporting the Health of Adults Undergoing Orthopedic Surgery During the Recovery Period". Delirium (acute confusion) is a highly prevalent condition among hospitalized elders with substantial morbidity within the hospital and beyond. Particular patient populations are at high risk for poor outcomes after an episode of delirium. Patients with hip and other long bone fractures are at incre...
What is the current status of trial NCT00586196?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2007-01. Estimated completion is 2013-02.
What interventions are being tested in trial NCT00586196?
The interventions under investigation include: Placebo (DRUG), donepezil (DRUG).
Who is sponsoring clinical trial NCT00586196?
This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.
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