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NCT00335504 · ClinicalTrials.gov registry record · Phase 2
Atorvastatin Calcium, Oligofructose-Enriched Inulin, or Sulindac in Preventing Cancer in Patients at Increased Risk of Developing Colorectal Neoplasia
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 85
- Enrollment target
NCT00335504: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00335504 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 85 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (36% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00335504, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 85 participants
- Enrollment target
Study Summary
This randomized phase II trial is studying atorvastatin calcium to see how well it works compared to oligofructose-enriched inulin, sulindac, or a placebo in preventing cancer in patients at increased risk of developing colorectal neoplasia. Chemoprevention is the use of certain drugs or substances to keep cancer from forming, growing, or coming back. The use of atorvastatin calcium, oligofructose-enriched inulin, or sulindac may stop cancer from forming in patients at increased risk of colorectal neoplasia. It is not yet known whether atorvastatin calcium, oligofructose-enriched inulin, or sulindac are more effective than a placebo in preventing cancer in patients at increased risk of developing colorectal neoplasia.
Primary Outcome
At the Pre-Intervention Evaluation, rectal ACF will be classified with respect to ACF number, crypt number, crypt size, tissue plane, staining intensity, and (optional) lumen shape for each subject. At the Post- Intervention Evaluation, these same parameters will be recorded and incident vs prevalent rectal ACF status will also be recorded. Compare each non-placebo arms versus the placebo arm to screen the three active study agents for possible phase III testing.
Interventions
- DRUG placebo
- OTHER laboratory biomarker analysis
- DRUG sulindac
- DRUG atorvastatin calcium
- DRUG oligofructose-enriched inulin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 85 participants |
| Start Date | 2006-03 |
| Est. Completion | 2009-04 |
| Phase | Phase 2 |
What the finished NCT00335504 record still lists
NCT00335504 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 85 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (36% lower).
The record links to 0 conditions, and to 5 interventions - of which placebo is the first listed.
NCT00335504 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00335504 about?
NCT00335504 is a clinical study titled "Atorvastatin Calcium, Oligofructose-Enriched Inulin, or Sulindac in Preventing Cancer in Patients at Increased Risk of Developing Colorectal Neoplasia". This randomized phase II trial is studying atorvastatin calcium to see how well it works compared to oligofructose-enriched inulin, sulindac, or a placebo in preventing cancer in patients at increased risk of developing colorectal neoplasia. Chemoprevention is the use of certain drugs or substances ...
What is the current status of trial NCT00335504?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 85 participants. The study started on 2006-03. Estimated completion is 2009-04.
What interventions are being tested in trial NCT00335504?
The interventions under investigation include: placebo (DRUG), laboratory biomarker analysis (OTHER), sulindac (DRUG), atorvastatin calcium (DRUG), oligofructose-enriched inulin (DRUG).
Who is sponsoring clinical trial NCT00335504?
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 NCT00335504's enrollment target sits among peer trials
85 820th of 2000 higher than 1,179 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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