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NCT00983580 · ClinicalTrials.gov registry record · Phase 2
Acetylsalicylic Acid and Eflornithine in Treating Patients at High Risk for Colorectal Cancer
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 107
- Enrollment target
NCT00983580: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00983580 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 107 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00983580, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 107 participants
- Enrollment target
Study Summary
This phase II trial is studying how well giving acetylsalicylic acid together with eflornithine works in treating patients at high risk for colorectal cancer. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of acetylsalicylic acid and eflornithine may prevent colorectal cancer.
Primary Outcome
The primary endpoint is the proportion of participants with an adenoma recurrence at the 1-year follow-up colonoscopy exam. All eligible, randomized participants who have signed a consent form and received at least one follow-up endoscopy exam will be considered evaluable for the primary endpoint. This adenoma recurrence rate for DFMO + aspirin will be compared to double placebo to see if there is improvement in the adenoma recurrence rate in this patient population. A 1-sided Chi-square test wa
Interventions
- OTHER Placebo
- OTHER Laboratory Biomarker Analysis
- DRUG Aspirin
- DRUG Eflornithine
- OTHER Telephone-Based Intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 107 participants |
| Start Date | 2009-08-20 |
| Est. Completion | 2019-08-13 |
| Phase | Phase 2 |
What the finished NCT00983580 record still lists
NCT00983580 is an interventional study that assigns participants to a tested intervention. The registered 107 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% lower).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT00983580 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00983580 about?
NCT00983580 is a clinical study titled "Acetylsalicylic Acid and Eflornithine in Treating Patients at High Risk for Colorectal Cancer". This phase II trial is studying how well giving acetylsalicylic acid together with eflornithine works in treating patients at high risk for colorectal cancer. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of acetylsalicylic acid and eflornithine may prevent colorec...
What is the current status of trial NCT00983580?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 107 participants. The study started on 2009-08-20. Estimated completion is 2019-08-13.
What interventions are being tested in trial NCT00983580?
The interventions under investigation include: Placebo (OTHER), Laboratory Biomarker Analysis (OTHER), Aspirin (DRUG), Eflornithine (DRUG), Telephone-Based Intervention (OTHER).
Who is sponsoring clinical trial NCT00983580?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00983580's enrollment target sits among peer trials
107 646th of 2000 higher than 1,353 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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