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NCT02226484 · ClinicalTrials.gov registry record · Phase 1
Can Quercetin Increase Claudin-4 and Improve Esophageal Barrier Function in GERD?
A Phase 1 study of Gastroesophageal Reflux Disease and GERD, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
- 1
- Study location
NCT02226484 is a Phase 1 study of Gastroesophageal Reflux Disease and GERD that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 26 participants, below the 347-participant average among 24 other Gastroesophageal Reflux Disease trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02226484, a Phase 1 study of Gastroesophageal Reflux Disease and GERD, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
- 1
- Study location
Study Summary
Purpose: 1. Determine if oral quercetin increases the expression of claudin-4 in the lining of the esophagus of patients with a diagnosis of gastroesophageal reflux disease (GERD); and 2. Determine whether the increase in claudin-4 by oral quercetin is accompanied by improvement in the barrier function and acid resistance of the lining of the esophagus of patients with a diagnosis of gastroesophageal reflux disease (GERD) If interested, participants will be consented and provided a questionnaire to complete as part of the study. Participants will undergo endoscopy for routine care and will have up to 8 esophageal biopsies (small tissue samples) taken for the research study. After endoscopy, participants will be contacted to begin a 6 week treatment period with study drug (Quercetin, taken twice daily). At the end of the 6 week period, participants will be scheduled to have blood drawn and to have a follow-up endoscopy with biopsies performed for the research study.
Conditions Studied
Interventions
- DRUG Quercetin
Study Locations (1)
North Carolina
- UNC Chapel Hill - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2014-08 |
| Est. Completion | 2016-06 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02226484
The ClinicalTrials.gov registry entry for NCT02226484 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 347-participant average among 24 other Gastroesophageal Reflux Disease trials with a reported enrollment target (93% lower). The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Gastroesophageal Reflux Disease appearing as the primary indexed condition, and to 1 intervention - of which Quercetin is the first listed.
NCT02226484 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT02226484 about?
NCT02226484 is a clinical study titled "Can Quercetin Increase Claudin-4 and Improve Esophageal Barrier Function in GERD?". Purpose: 1. Determine if oral quercetin increases the expression of claudin-4 in the lining of the esophagus of patients with a diagnosis of gastroesophageal reflux disease (GERD); and 2. Determine whether the increase in claudin-4 by oral quercetin is accompanied by improvement in the barrier func...
What is the current status of trial NCT02226484?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2014-08. Estimated completion is 2016-06.
What conditions does trial NCT02226484 study?
This clinical trial studies the following conditions: Gastroesophageal Reflux Disease, GERD, Reflux, Acid Reflux.
What interventions are being tested in trial NCT02226484?
The interventions under investigation include: Quercetin (DRUG).
Who is sponsoring clinical trial NCT02226484?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02226484 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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