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The Effect of Donepezil on Sedation and Other Symptoms

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ClinicalTrials.gov Identifier: NCT00352664
Recruitment Status : Terminated (Low patient accrual)
First Posted : July 14, 2006
Results First Posted : December 29, 2009
Last Update Posted : May 9, 2016
Sponsor:
Collaborator:
Pfizer
Information provided by:
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Advanced Cancer
Interventions Drug: Donepezil
Drug: Placebo
Enrollment 27
Recruitment Details Patient Recruitment: 12/10/03 for first patient through 09/14/05 for last patient. All participants recruited at UT MD Anderson Cancer Center.
Pre-assignment Details 27 patients were enrolled, 7 dropped out prior to assessment and were excluded from the overall study. Due to early termination, patients were not randomized.
Arm/Group Title Donepezil Placebo
Hide Arm/Group Description Oral Donepezil 5 mg daily x 7 days Oral Placebo tablet daily x 7 days
Period Title: Overall Study
Started 27 0
Completed 20 0
Not Completed 7 0
Reason Not Completed
Withdrawal by Subject             7             0
Arm/Group Title Donepezil Placebo Total
Hide Arm/Group Description Oral Donepezil 5 mg daily x 7 days Oral Placebo tablet daily x 7 days Total of all reporting groups
Overall Number of Baseline Participants 27 0 27
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 27 participants 0 participants 27 participants
56
(22 to 64)
56
(22 to 64)
Gender  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 27 participants 0 participants 27 participants
Female 18 18
Male 9 9
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 27 participants 0 participants 27 participants
27 27
1.Primary Outcome
Title Sedation Mean Scores at 1-Week
Hide Description Anderson Symptom Assessment Scale (ASAS) was used to measure sedation mean scores (SD) on a 0-10 scale with 0 representing “not drowsy” and 10 representing “worst possible drowsiness.”
Time Frame Baseline and Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat (ITT), and population analyzed was that treated. Study closed early due to low patient accrual and insufficient supply of drug. No patients were randomized to Placebo Arm.
Arm/Group Title Donepezil Placebo
Hide Arm/Group Description:
Oral Donepezil 5 mg daily x 7 days
Oral Placebo tablet daily x 7 days
Overall Number of Participants Analyzed 20 0
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
Baseline 6.44  (1.2)
Day 7 4.81  (2.6)
Time Frame 4 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Donepezil Placebo
Hide Arm/Group Description Oral Donepezil 5 mg daily x 7 days Oral Placebo tablet daily x 7 days
All-Cause Mortality
Donepezil Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Donepezil Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      0/0    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Donepezil Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   17/20 (85.00%)      0/0    
Gastrointestinal disorders     
Nausea/vomiting   6/20 (30.00%)  6 0/0  0
Diarrhea   5/20 (25.00%)  5 0/0  0
General disorders     
Anorexia   4/20 (20.00%)  4 0/0  0
Muscle Cramps   2/20 (10.00%)  2 0/0  0
Indicates events were collected by systematic assessment
Insufficient drug supply and low patient accrual closed study early.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Eduardo Bruera, MD / Professor
Organization: UT MD Anderson Cancer Center
Phone: 713-792-6084
Layout table for additonal information
Responsible Party: Eduardo Bruera, MD / Professor, UT MD Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00352664     History of Changes
Other Study ID Numbers: 2003-0425
First Submitted: July 12, 2006
First Posted: July 14, 2006
Results First Submitted: May 21, 2009
Results First Posted: December 29, 2009
Last Update Posted: May 9, 2016