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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: Completed Phase 1 study, sponsored by Eisai.

NCT01153659 is a Phase 1 study that has completed, run by Eisai. The registered enrollment target is 90 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% higher). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 90 participants
Start Date 2010-07
Est. Completion 2010-10
Phase Phase 1
Eisai

287 total trials

What the finished NCT01153659 record still lists

NCT01153659 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% higher).

The record links to 0 conditions, and to 3 interventions - of which E3810 is the first listed.

NCT01153659 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT01153659's enrollment target sits among peer trials

90 628th of 2000 higher than 1,352 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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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Source: ClinicalTrials.gov NCT01153659, the US trial registry maintained by the National Library of Medicine. NCT01153659 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.