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NCT00118365 · ClinicalTrials.gov registry record · Phase 3
Eflornithine and Sulindac in Preventing Colorectal Cancer in Patients With Colon Polyps
A Phase 3 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 3
- Development phase
- 375
- Enrollment target
NCT00118365: Completed Phase 3 study, sponsored by National Cancer Institute (NCI).
NCT00118365 is a Phase 3 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 375 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (51% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00118365, a Phase 3 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 375 participants
- Enrollment target
Study Summary
This randomized phase III trial is studying eflornithine and sulindac to see how well they work compared to a placebo in preventing colorectal cancer in patients with colon polyps. Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of eflornithine and sulindac may prevent colorectal cancer. It is not yet known whether eflornithine and sulindac are more effective than a placebo in preventing colorectal cancer
Primary Outcome
Detection of any adenoma at the end of the study. This analysis is based on the participants who had the end-of-study colonscopy procedure done.
Interventions
- OTHER laboratory biomarker analysis
- OTHER placebo
- DRUG sulindac
- DRUG eflornithine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 375 participants |
| Start Date | 1998-07 |
| Est. Completion | 2008-08 |
| Phase | Phase 3 |
What the finished NCT00118365 record still lists
NCT00118365 is an interventional study that assigns participants to a tested intervention. The registered 375 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (51% lower).
The record links to 0 conditions, and to 4 interventions - of which laboratory biomarker analysis is the first listed.
NCT00118365 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00118365 about?
NCT00118365 is a clinical study titled "Eflornithine and Sulindac in Preventing Colorectal Cancer in Patients With Colon Polyps". This randomized phase III trial is studying eflornithine and sulindac to see how well they work compared to a placebo in preventing colorectal cancer in patients with colon polyps. Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of eflornithi...
What is the current status of trial NCT00118365?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 375 participants. The study started on 1998-07. Estimated completion is 2008-08.
What interventions are being tested in trial NCT00118365?
The interventions under investigation include: laboratory biomarker analysis (OTHER), placebo (OTHER), sulindac (DRUG), eflornithine (DRUG).
Who is sponsoring clinical trial NCT00118365?
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 NCT00118365's enrollment target sits among peer trials
375 988th of 2000 higher than 1,010 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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