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NCT00693225 · ClinicalTrials.gov registry record · Phase 4
Impact of Timing on the Efficacy of Zegerid 40 mg in Healing Reflux Esophagitis: A Pilot Study
A Phase 4 study of Erosive Esophagitis, sponsored by Yvonne Romero.
- Completed
- Registry status
- Phase 4
- Development phase
- 91
- Enrollment target
- 1
- Study location
NCT00693225: Completed Phase 4 study of Erosive Esophagitis, sponsored by Yvonne Romero.
NCT00693225 is a Phase 4 study of Erosive Esophagitis that has completed, run by Yvonne Romero. The registered enrollment target is 91 participants, below the 196-participant average among 6 other Erosive Esophagitis trials with a reported enrollment target (54% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00693225, a Phase 4 study of Erosive Esophagitis, has completed, sponsored by Yvonne Romero.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 91 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study was to determine the effect of morning versus bedtime administration of omeprazole/sodium bicarbonate (Zegerid) on endoscopic healing for patients with moderate or severe reflux esophagitis. Our hypothesis was that bedtime administration of Zegerid would be superior in healing esophagitis compared to morning administration prior to a meal.
Primary Outcome
After 8 weeks of treatment a follow-up esophagogastroduodenoscopy (EGD) was performed by an endoscopist blinded to the study and subject allocation. The evaluation results were grouped as follows: LA C esophagitis at baseline: healed = no erosions in the esophagus; improved= LA grades A or B; Same or worse = C or D at follow-up LA D esophagitis at baseline: healed = no erosions in the esophagus; improved=LA grades A, B, or C; Same=LA grade D at follow-up.
Conditions Studied
Interventions
- DRUG Omeprazole/sodium bicarbonate
Study Locations (1)
Minnesota
- Mayo Clinic - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 91 participants |
| Start Date | 2008-01 |
| Est. Completion | 2010-12 |
| Phase | Phase 4 |
What the finished NCT00693225 record still lists
NCT00693225 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 91 participants, a relatively small participant target, below the 196-participant average among 6 other Erosive Esophagitis trials with a reported enrollment target (54% lower).
The record links to 1 condition, with Erosive Esophagitis appearing as the primary indexed condition, and to 1 intervention - of which Omeprazole/sodium bicarbonate is the first listed.
NCT00693225 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT00693225 about?
NCT00693225 is a clinical study titled "Impact of Timing on the Efficacy of Zegerid 40 mg in Healing Reflux Esophagitis: A Pilot Study". The purpose of this study was to determine the effect of morning versus bedtime administration of omeprazole/sodium bicarbonate (Zegerid) on endoscopic healing for patients with moderate or severe reflux esophagitis. Our hypothesis was that bedtime administration of Zegerid would be superior in heal...
What is the current status of trial NCT00693225?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 91 participants. The study started on 2008-01. Estimated completion is 2010-12.
What conditions does trial NCT00693225 study?
This clinical trial studies the following conditions: Erosive Esophagitis.
What interventions are being tested in trial NCT00693225?
The interventions under investigation include: Omeprazole/sodium bicarbonate (DRUG).
Who is sponsoring clinical trial NCT00693225?
This trial is sponsored by Yvonne Romero, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00693225 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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