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Study in Elderly Alzheimer's Patients to Assess Skin Tolerability, Irritation With 3, 7-Day Applications of DTP-System

NCT00916383 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2021-10-28

Study results available
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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.

Conditions

  • Irritation/Irritant

Interventions

DRUG

350 mg Donepezil Transdermal Patch

Active and placebo patches will be applied to opposite sides for 7 days.

DRUG

Placebo Patch

Active and placebo patches will be applied to opposite sides for 7 days.

Sponsors & Collaborators

  • Teikoku Pharma USA, Inc.

    lead INDUSTRY

Principal Investigators

  • James Song, MS, MBA · Teikoku Pharma USA, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2009-06-30
Completion
2009-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00916383 on ClinicalTrials.gov