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NCT00858858 · ClinicalTrials.gov registry record · NA
Clinical Studies on Bile Acids in Barrett's Esophagus
A NA study, sponsored by US Department of Veterans Affairs.
- Completed
- Registry status
- NA
- Development phase
- 60
- Enrollment target
NCT00858858: Completed NA study, sponsored by US Department of Veterans Affairs.
NCT00858858 is a NA study that has completed, run by US Department of Veterans Affairs. The registered enrollment target is 60 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00858858, a NA study, has completed, sponsored by US Department of Veterans Affairs.
- COMPLETED
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
Study Summary
This study has two major goals: 1. To determine the effects of bile salts on causing DNA injury and activating signaling pathways that promote growth in cells from the esophagus of patients who have gastroesophageal reflux disease (GERD) 2. To determine whether changes in bile composition induced by treating patients with a bile salt called ursodeoxycholic acid (UDCA) can alter DNA injury, signaling pathway activation and other types of damage in cells from the esophagus of patients who have GERD.
Primary Outcome
p-H2AX levels are a measure of DNA damage. Our major outcome measure is the change in p-H2AX levels, expressed as relative densitometry units, after DCA perfusion in patients treated with oral UDCA. If UDCA protects against bile acid-induced DNA damage, then p-H2AX levels before and after perfusion should not change significantly.
Interventions
- DRUG Ursodeoxycholic Acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2009-03 |
| Est. Completion | 2015-02 |
| Phase | NA |
What the finished NCT00858858 record still lists
NCT00858858 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Ursodeoxycholic Acid is the first listed.
NCT00858858 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00858858 about?
NCT00858858 is a clinical study titled "Clinical Studies on Bile Acids in Barrett's Esophagus". This study has two major goals: 1. To determine the effects of bile salts on causing DNA injury and activating signaling pathways that promote growth in cells from the esophagus of patients who have gastroesophageal reflux disease (GERD) 2. To determine whether changes in bile composition induced b...
What is the current status of trial NCT00858858?
This trial is currently completed. It is a NA study. The enrollment target is 60 participants. The study started on 2009-03. Estimated completion is 2015-02.
What interventions are being tested in trial NCT00858858?
The interventions under investigation include: Ursodeoxycholic Acid (DRUG).
Who is sponsoring clinical trial NCT00858858?
This trial is sponsored by US Department of Veterans Affairs, which has 632 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00858858's enrollment target sits among peer trials
60 1164th of 2000 higher than 745 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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