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NCT00352664 · ClinicalTrials.gov registry record · Phase 3

The Effect of Donepezil on Sedation and Other Symptoms

A Phase 3 study, sponsored by M.D. Anderson Cancer Center.

Terminated
Registry status
Phase 3
Development phase
27
Enrollment target

NCT00352664: Clinical Trial Phase 3 study, sponsored by M.D. Anderson Cancer Center.

NCT00352664 is a Phase 3 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 27 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT00352664, a Phase 3 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.

TERMINATED
Registry status
Phase 3
Development phase
27 participants
Enrollment target

Study 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)

Primary Outcome

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."

Interventions

  • DRUG Placebo
  • DRUG Donepezil

Trial Details

FieldValue
Enrollment Target 27 participants
Start Date 2003-11
Est. Completion 2007-07
Phase Phase 3
M.D. Anderson Cancer Center

2,692 total trials

Why NCT00352664 stopped before completion

NCT00352664 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT00352664 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00352664 about?

NCT00352664 is a clinical study titled "The Effect of Donepezil on Sedation and Other Symptoms". 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 place...

What is the current status of trial NCT00352664?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 27 participants. The study started on 2003-11. Estimated completion is 2007-07.

What interventions are being tested in trial NCT00352664?

The interventions under investigation include: Placebo (DRUG), Donepezil (DRUG).

Who is sponsoring clinical trial NCT00352664?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00352664's enrollment target sits among peer trials

27 1936th of 2000 higher than 64 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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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Source: ClinicalTrials.gov NCT00352664, the US trial registry maintained by the National Library of Medicine. NCT00352664 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.