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NCT00825227 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of Armodafinil for Fatigue Associated With Taxanes Alone or in Combination With Other Agents
A Phase 2 study, sponsored by Cephalon.
- Terminated
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT00825227: Clinical Trial Phase 2 study, sponsored by Cephalon.
NCT00825227 is a Phase 2 study that was terminated before completion, run by Cephalon. The registered enrollment target is 10 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00825227, a Phase 2 study, was terminated before completion, sponsored by Cephalon.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
Study Summary
Evaluate the Safety and Efficacy of Armodafinil Treatment for Patients With Fatigue Associated With Taxane Chemotherapy Alone or in Combination With Other Agents
Primary Outcome
Brief Fatigue Inventory (BFI) measures fatigue severity and impact on function on 11-point scale (0-10). Primary outcome measure is average daily rating of BFI question 3: worst level of fatigue over past 24-hours. 0 = no fatigue, 10 = worst imaginable. Study was terminated after only a few patients enrolled and therefore efficacy results were not analyzed and are not reported. Maximum response (most fatigue) would score 10 and minimum response (least fatigue) would score 0. Change was measured
Interventions
- DRUG Armodafinil 150 mg/day
- DRUG Placebo,
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2008-12 |
| Est. Completion | 2010-02 |
| Phase | Phase 2 |
Why NCT00825227 stopped before completion
NCT00825227 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Armodafinil 150 mg/day is the first listed.
NCT00825227 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00825227 about?
NCT00825227 is a clinical study titled "Safety and Efficacy of Armodafinil for Fatigue Associated With Taxanes Alone or in Combination With Other Agents". Evaluate the Safety and Efficacy of Armodafinil Treatment for Patients With Fatigue Associated With Taxane Chemotherapy Alone or in Combination With Other Agents
What is the current status of trial NCT00825227?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2008-12. Estimated completion is 2010-02.
What interventions are being tested in trial NCT00825227?
The interventions under investigation include: Armodafinil 150 mg/day (DRUG), Placebo, (DRUG).
Who is sponsoring clinical trial NCT00825227?
This trial is sponsored by Cephalon, which has 64 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00825227's enrollment target sits among peer trials
10 1968th of 2000 higher than 12 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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