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The Effect of Donepezil on Sedation and Other Symptoms

NCT00352664 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2016-05-09

Study results available
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Summary

Primary Objective:

1\. To determine the effectiveness of donepezil as compared to placebo for the management of opiate-induced sedation/drowsiness in patients with stable cancer pain

Secondary Objectives:

1. To assess the side-effects in both groups of 1 week treatment of 5 mg donepezil and placebo
2. To assess the effects of donepezil on fatigue (FACIT-Fatigue), and other symptoms (Anderson Symptom Assessment Scale)
3. To assess the effects of donepezil on cognition (Symbol Digit Modalities Test)
4. To assess the effects of donepezil on constipation (number of bowel movements)

Conditions

Interventions

DRUG

Donepezil

5 mg once a day by mouth for 7 day cycle. After evaluation on Day 8, all participants will be offered donepezil every day for 7 days.

DRUG

Placebo

Placebo tablet once a day by mouth for one 7 day cycle. After evaluation on day 8, all participants offered donepezil every day for 7 days.

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Eduardo Bruera, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-11-30
Primary Completion
2007-07-31
Completion
2007-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT00352664 on ClinicalTrials.gov