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NCT00916383 · ClinicalTrials.gov registry record · Phase 2
Study in Elderly Alzheimer's Patients to Assess Skin Tolerability, Irritation With 3, 7-Day Applications of DTP-System
A Phase 2 study, sponsored by Teikoku Pharma USA.
- Completed
- Registry status
- Phase 2
- Development phase
- 49
- Enrollment target
NCT00916383: Completed Phase 2 study, sponsored by Teikoku Pharma USA.
NCT00916383 is a Phase 2 study that has completed, run by Teikoku Pharma USA. The registered enrollment target is 49 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00916383, a Phase 2 study, has completed, sponsored by Teikoku Pharma USA.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 49 participants
- Enrollment target
Study Summary
This study is designed to assess skin tolerability, skin irritation, and adhesion of the 350 mg Donepezil Transdermal Patch (DTP-system), following 3, 7-day applications to 3 specific areas of the body (upper back, upper middle arm, side of torso) of elderly Alzheimer's patients. The total application time for the DTP-system is 21 days.
Primary Outcome
Erythema and edema were used to determine skin irritation using a modified Draize scale. Score 0 = no erythema/edema; Score 1 = very slight erythema/edema; Score 2 = well-defined erythema/slight edema; Score 3 = moderate to severe erythema/edema; Score 4 = severe erythema/edema.
Interventions
- DRUG Placebo Patch
- DRUG 350 mg Donepezil Transdermal Patch
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2009-05 |
| Est. Completion | 2009-06 |
| Phase | Phase 2 |
What the finished NCT00916383 record still lists
NCT00916383 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo Patch is the first listed.
NCT00916383 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00916383 about?
NCT00916383 is a clinical study titled "Study in Elderly Alzheimer's Patients to Assess Skin Tolerability, Irritation With 3, 7-Day Applications of DTP-System". This study is designed to assess skin tolerability, skin irritation, and adhesion of the 350 mg Donepezil Transdermal Patch (DTP-system), following 3, 7-day applications to 3 specific areas of the body (upper back, upper middle arm, side of torso) of elderly Alzheimer's patients. The total applicati...
What is the current status of trial NCT00916383?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 49 participants. The study started on 2009-05. Estimated completion is 2009-06.
What interventions are being tested in trial NCT00916383?
The interventions under investigation include: Placebo Patch (DRUG), 350 mg Donepezil Transdermal Patch (DRUG).
Who is sponsoring clinical trial NCT00916383?
This trial is sponsored by Teikoku Pharma USA, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00916383's enrollment target sits among peer trials
49 1261st of 2000 higher than 736 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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