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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Compare PK, PD and Safety of the AD-214-02 and Rabeprazole

NCT04622358

Gastroesophageal Reflux Disease
COMPLETED PHASE1

Rabeprazole Extended-Release 50 mg Versus Esomeprazole 40 mg for Healing and Symptomatic Relief of Mild to Moderate Erosive Gastroesophageal Reflux Disease (GERD)

NCT00658632

Gastroesophageal Reflux Disease (GERD)
COMPLETED PHASE3

A Double-blind Comparative Study of the Efficacy and Safety of E3810 10mg Once and Twice Daily in Maintenance Therapy for PPI Resistant Gastroesophageal Reflux Disease Patients

NCT02135107

Gastroesophageal Reflux Disease
COMPLETED PHASE3

A Study to Compare PK, PD and Safety of the AD-214 10/600mg and Rabeprazole

NCT04494243

Gastroesophageal Reflux Disease
COMPLETED PHASE1

Comparison of Dexlansoprazole-based Triple and Rabeprazole-based Triple Therapies for Helicobacter Pylori Infection

NCT02541786

Helicobacter Pylori Infection
COMPLETED PHASE4

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

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

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Clinical Pharmacological Study of Rabeprazole Sodium in Japanese Healthy Adult Male Volunteers (Study E3810)
NCT01202071 COMPLETED PHASE2
Rabeprazole Extended-Release, 50 mg, Versus Esomeprazole, 40 mg, for Healing and Symptomatic Relief of Moderate to Severe Erosive Gastroesophageal Reflux Disease (GERD)
NCT00658775 COMPLETED PHASE3
A Study To Investigate The Effectiveness Of AH234844 (Lavoltidine) Compared With NEXIUM And Ranitidine.
NCT00405119 COMPLETED PHASE2
Relative Bioavailability and PPI Effects of CC-92480 Test and Reference Formulations in Healthy Subjects
NCT04211545 COMPLETED PHASE1
A Study to Investigate the Effect of Increased Gastric pH on the Oral Bioavailability of the Orexin-2 Receptor Antagonist JNJ-42847922 in Healthy Participants
NCT02475161 COMPLETED PHASE1
A Bioequivalence Study of 2 Formulations of Rabeprazole Sodium and Evaluation of the Effect of Food on Rabeprazole Sodium in Healthy Adult Volunteers
NCT01241409 COMPLETED PHASE1
A Pharmacokinetic and Relative Bioavailability Study With Rabeprazole Sodium in Healthy Adult Volunteers
NCT01101646 COMPLETED PHASE1
To Evaluate Pharmacokinetics and Pharmacodynamics of Z-215 in Healthy Male Subjects
NCT02509923 COMPLETED PHASE1
A Study of Rabeprazole and Pantoprazole on Stomach Acid and Esophageal Acid Exposure in Patients With Gastroesophageal Reflux Disease (GERD) and a History of Nighttime Heartburn
NCT00237367 COMPLETED PHASE4
Study to Evaluate the Effect of Rabeprazole on the Pharmacokinetics of Vadadustat
NCT03789032 COMPLETED PHASE1
A Double-blind, Comparative Study in Patients With Gastric Ulcer to Evaluate the Efficacy of Combination Use of E0671 and Rabeprazole Sodium
NCT00125736 COMPLETED PHASE4
A 3-Part Study to Determine the Relative Bioavailability of Capsule and Tablet Formulations of GDC-0980, the Effect of Food, and the Effect of Rabeprazole on the Pharmacokinetics of the Tablet
NCT01287091 COMPLETED PHASE1
A Study of Acalabrutinib Suspension to Evaluate Relative Bioavailability and Proton-pump Inhibitor Effect in Healthy Volunteers
NCT04435483 COMPLETED PHASE1
Evaluation of Rebamipide and Rabeprazole Effect Associated or Not to Prevent Naproxen-induced Gastric Lesions
NCT03658473 COMPLETED PHASE3
Relative Bioavailability of ESK-001 Tablet Versus Liquid in Healthy Participants
NCT05330858 COMPLETED PHASE1
Study of the Safety and Effectiveness of Rabeprazole in Treatment of Helicobacter Pylori Infection in Adults.
NCT00216450 COMPLETED PHASE4
A Study to Determine the Relative Bioavailability of Capsule and Tablet Formulations of GDC-0941 and the Effect of Food and Proton Pump Inhibition on GDC-0941 Tablet Pharmacokinetics in Healthy Volunteers
NCT00999128 COMPLETED PHASE1
A Comparative Efficacy and Safety Study of Nexium Delayed-Release Capsules (40mg qd and 20mg qd) Versus Ranitidine 150mg Bid for the Healing of NSAID-Associated Gastric Ulcers When Daily NSAID Use is Continued in Subjects in the US Only
NCT00633412 COMPLETED PHASE3
A Study to Compare the Relative Bioavailability of Two AG-881 Formulations and Evaluate the Effect of Food and Omeprazole on the Pharmacokinetics of AG-881
NCT04128787 COMPLETED PHASE1
Rabeprazole Extended-Release 50 mg vs. Ranitidine 150 mg for Maintenance of Healed Erosive Gastroesophageal Reflux Disease (GERD)
NCT00838526 COMPLETED PHASE3
Rabeprazole Extended-Release 50 mg Versus Esomeprazole 40 mg for Healing and Symptomatic Relief of Moderate to Severe Erosive Gastroesophageal Reflux Disease (GERD)
NCT00658528 COMPLETED PHASE3
To Assess the Efficacy of Esomeprazole 40 mg Once Daily in Subjects Who Still Had Heartburn After Receiving Rabeprazole
NCT01249651 COMPLETED PHASE4
Relative Bioavailability of NX-5948 Tablets vs Capsules and the Effect of Covariates on the PK of NX-5948 Tablets
NCT06717269 RECRUITING PHASE1
Nexium Dyspepsia/AST
NCT00251914 COMPLETED PHASE3
A Study to Evaluate Effects of Proton-pump Inhibitor on Acalabrutinib Capsule When Administered Orally With COCA-COLA in Healthy Participants
NCT04489797 COMPLETED PHASE1