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

October 31, 2013 updated by: Eisai Inc.

A Randomized, Open-Label, Three-Way Crossover Study to Evaluate the Effect on 24-hour, Intragastric pH Following Daily Oral Dose Administration of RAB ER 50-mg Capsules Compared With Esomeprazole (Nexium) 40-mg Capsules and Rabeprazole (Aciphex) 20-mg Tablets to H. Pylori-Negative Healthy Subjects in a 5-day Treatment Regimen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma Foundation for Digestive Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Key inclusion:

  • Healthy male and female subjects, including women of child-bearing potential, aged 18 to 55 years, inclusive
  • Subjects who are able to tolerate the insertion and placement of a pH probe on 2 occasions per study period (Day -1 and Day 5)

Key Exclusion:

  • Subjects who are H. pylori-positive
  • Subjects who have a history of any gastrointestinal disorder or surgery likely to influence drug absorption (e.g., history of gastric resection)
  • Known hypersensitivity to rabeprazole, esomeprazole, or related compounds or any ingredient in the formulations
  • Other standard clinical pharmacology exclusion criteria for healthy volunteers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 2
Drug: Aciphex (rabeprazole)
Aciphex (rabeprazole) 20 mg tablet once per day on Days 1-5
EXPERIMENTAL: 1
Drug: E3810
RAB ER 50 mg capsule once per day on Days 1-5
ACTIVE_COMPARATOR: 3
Drug: Nexium (esomeprazole)
Nexium (esomeprazole) 40 mg capsule once per day on Days 1-5

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of time that intragastric pH remains >4
Time Frame: 24-hr period post-dose on Day 5
24-hr period post-dose on Day 5

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of day- and night-time periods with intragastric pH >4
Time Frame: Days 1 and 5
Days 1 and 5
Number and duration of nocturnal acid breakthrough (NAB) episodes
Time Frame: Days 1 and 5
Days 1 and 5
Proportion of subjects with nocturnal acid breakthrough (NAB) episodes
Time Frame: Days 1 and 5
Days 1 and 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eisai Inc.

Investigators

  • Principal Investigator: Philip Miner, Oklahoma Foundation for Digestive Research, 1000 N. Lincoln, Suite 210, Oklahoma City, OK 73104 USA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (ACTUAL)

August 1, 2010

Study Completion (ACTUAL)

October 1, 2010

Study Registration Dates

First Submitted

June 28, 2010

First Submitted That Met QC Criteria

June 29, 2010

First Posted (ESTIMATE)

June 30, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

November 1, 2013

Last Update Submitted That Met QC Criteria

October 31, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E3810-A001-038

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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