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NCT01097304 · ClinicalTrials.gov registry record · Phase 2
Ursodiol in Treating Patients With Barrett Esophagus and Low-Grade Dysplasia
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
NCT01097304: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT01097304 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 36 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01097304, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
Study Summary
This pilot phase II trial studies how well ursodiol works in treating patients with Barrett esophagus or cells that look abnormal under a microscope but are not cancer (low-grade dysplasia). Chemoprevention is the use of certain drugs to keep cancer from forming. The use of ursodiol may keep cancer for forming in patients with Barrett esophagus or low-grade dysplasia.
Primary Outcome
8OHdG will be assessed by percentage of positively stained nuclear area. A paired t-test at a one-sided 0.05 significance level will be used to assess change during intervention. The observed results will be reported along with the corresponding confidence intervals.
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Ursodiol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2010-04 |
| Est. Completion | 2014-07 |
| Phase | Phase 2 |
What the finished NCT01097304 record still lists
NCT01097304 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 2 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT01097304 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01097304 about?
NCT01097304 is a clinical study titled "Ursodiol in Treating Patients With Barrett Esophagus and Low-Grade Dysplasia". This pilot phase II trial studies how well ursodiol works in treating patients with Barrett esophagus or cells that look abnormal under a microscope but are not cancer (low-grade dysplasia). Chemoprevention is the use of certain drugs to keep cancer from forming. The use of ursodiol may keep cancer ...
What is the current status of trial NCT01097304?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2010-04. Estimated completion is 2014-07.
What interventions are being tested in trial NCT01097304?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Ursodiol (DRUG).
Who is sponsoring clinical trial NCT01097304?
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 NCT01097304's enrollment target sits among peer trials
36 1496th of 2000 higher than 477 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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