MedDataX Logo

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

NCT ID: NCT01153659

Last Updated: 2013-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2010-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

rabeprazole esomeprazole h. pylori-negative nocturnal acid breakthrough intragastric pH, PK/PD effect on gastric pH in healthy, H. pylori-Negative subjects

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Group Type EXPERIMENTAL

E3810

Intervention Type DRUG

RAB ER 50 mg capsule once per day on Days 1-5

2

Group Type ACTIVE_COMPARATOR

Aciphex (rabeprazole)

Intervention Type DRUG

Aciphex (rabeprazole) 20 mg tablet once per day on Days 1-5

3

Group Type ACTIVE_COMPARATOR

Nexium (esomeprazole)

Intervention Type DRUG

Nexium (esomeprazole) 40 mg capsule once per day on Days 1-5

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

E3810

RAB ER 50 mg capsule once per day on Days 1-5

Intervention Type DRUG

Aciphex (rabeprazole)

Aciphex (rabeprazole) 20 mg tablet once per day on Days 1-5

Intervention Type DRUG

Nexium (esomeprazole)

Nexium (esomeprazole) 40 mg capsule once per day on Days 1-5

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Eisai Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Philip Miner

Role: PRINCIPAL_INVESTIGATOR

Oklahoma Foundation for Digestive Research, 1000 N. Lincoln, Suite 210, Oklahoma City, OK 73104 USA

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Oklahoma Foundation for Digestive Research

Oklahoma City, Oklahoma, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

E3810-A001-038

Identifier Type: -

Identifier Source: org_study_id