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NCT00033371 · ClinicalTrials.gov registry record · Phase 2
Celecoxib With or Without Eflornithine in Preventing Colorectal Cancer in Patients With Familial Adenomatous Polyposis
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 205
- Enrollment target
NCT00033371: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00033371 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 205 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (54% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00033371, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 205 participants
- Enrollment target
Study Summary
This randomized phase II trial studies how well giving celecoxib with or without eflornithine works in preventing colorectal cancer in patients with familial adenomatous polyposis. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of celecoxib and eflornithine may keep cancer from forming in patients with familial adenomatous polyposis.
Primary Outcome
Differences between average treatment effects of two study arms tested using two-sided type I error rate of 5% in two-sample t-test. If model assumptions not met by data or transformations of data, appropriate nonparametric tests (e.g. Wilcoxon rank sums test) were used to compare treatment arms - Percent change of polyp counts from baseline to 6 months, ie \[(6 months - baseline) x 100\]/baseline (%). For each participant, first were matched polyps between baseline \& 6 months by region and lan
Interventions
- OTHER Placebo
- DRUG Celecoxib
- OTHER Questionnaire administration
- OTHER Laboratory biomarker analysis
- DRUG eflornithine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 205 participants |
| Start Date | 2001-12-13 |
| Est. Completion | 2009-03-24 |
| Phase | Phase 2 |
What the finished NCT00033371 record still lists
NCT00033371 is an interventional study that assigns participants to a tested intervention. The registered 205 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (54% higher).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT00033371 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00033371 about?
NCT00033371 is a clinical study titled "Celecoxib With or Without Eflornithine in Preventing Colorectal Cancer in Patients With Familial Adenomatous Polyposis". This randomized phase II trial studies how well giving celecoxib with or without eflornithine works in preventing colorectal cancer in patients with familial adenomatous polyposis. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of celecoxib and eflornithine may keep...
What is the current status of trial NCT00033371?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 205 participants. The study started on 2001-12-13. Estimated completion is 2009-03-24.
What interventions are being tested in trial NCT00033371?
The interventions under investigation include: Placebo (OTHER), Celecoxib (DRUG), Questionnaire administration (OTHER), Laboratory biomarker analysis (OTHER), eflornithine (DRUG).
Who is sponsoring clinical trial NCT00033371?
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 NCT00033371's enrollment target sits among peer trials
205 298th of 2000 higher than 1,702 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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