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NCT01153659 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Effect on 24-hour, Intragastric pH of RAB ER 50-mg Capsules Compared With Esomeprazole (Nexium) 40 mg Capsules and Rabeprazole (Aciphex) 20-mg Tablets
A Phase 1 study, sponsored by Eisai.
- Completed
- Registry status
- Phase 1
- Development phase
- 90
- Enrollment target
NCT01153659 is a Phase 1 study that has completed, run by Eisai. The registered enrollment target is 90 participants.
The verdict
NCT01153659, a Phase 1 study, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 90 participants
- Enrollment target
Study Summary
This will be a randomized, open-label, single-center, 3-way crossover study in healthy subjects who are confirmed to be Helicobacter pylori (H. pylori)-negative. The study will consist of 3 study periods separated by a washout period of at least 7 days. Subjects will receive study drugs once daily for 5 days. Barring any safety concerns, subjects will be discharged from the study on Day 6 of Period 3 after completion of discharge procedures.
Interventions
- DRUG E3810
- DRUG Aciphex (rabeprazole)
- DRUG Nexium (esomeprazole)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2010-07 |
| Est. Completion | 2010-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01153659
The ClinicalTrials.gov registry entry for NCT01153659 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eisai, which has 287 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which E3810 is the first listed.
NCT01153659 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01153659 about?
NCT01153659 is a clinical study titled "A Study to Evaluate the Effect on 24-hour, Intragastric pH of RAB ER 50-mg Capsules Compared With Esomeprazole (Nexium) 40 mg Capsules and Rabeprazole (Aciphex) 20-mg Tablets". This will be a randomized, open-label, single-center, 3-way crossover study in healthy subjects who are confirmed to be Helicobacter pylori (H. pylori)-negative. The study will consist of 3 study periods separated by a washout period of at least 7 days. Subjects will receive study drugs once daily f...
What is the current status of trial NCT01153659?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 90 participants. The study started on 2010-07. Estimated completion is 2010-10.
What interventions are being tested in trial NCT01153659?
The interventions under investigation include: E3810 (DRUG), Aciphex (rabeprazole) (DRUG), Nexium (esomeprazole) (DRUG).
Who is sponsoring clinical trial NCT01153659?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
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