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Comparison of the Nighttime Effects of Two Different Drugs on Subjects With GERD

NCT ID: NCT00304421

Last Updated: 2007-09-17

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2007-09-30

Brief Summary

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The purpose of the study is to compare the effect of two different drugs, rabeprazole (20 mg) and pantoprazole (40 mg), and their effects on the amount of acid produced by your stomach on evening and at night after standard protein meal.

Detailed Description

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Gastric acid secretion can be divided into two phases: the daytime phase and the nocturnal phase. Nocturnal acid reflux is presumably more damaging because of loss of salivary neutralization. The present study is designed to measure effects of rabeprazole and pantoprazole on post-prandial and nocturnal gastric acid secretion and intragastric pH in H. pylori-negative volunteers with gastroesophageal reflux disease. These measurement will be used to compare the degree of inhibition of gastric acid secretion between the two drugs.

Conditions

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Gastroesophageal Reflux Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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rabeprazole

Intervention Type DRUG

pantoprazole

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Subjects, 18-65 years of age, inclusive, male or female, of any race, who are willing to undergo testing at the study center.
2. Female subjects must not be able to conceive by reason of surgery, radiation, 2 years past the onset of menopause, or an approved method of contraception (e.g., IUD, oral contraceptives for at least one cycle, implant, or double barrier method). Female subjects of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test before medication is dispensed.
3. Subjects must have a negative result on the screening for H. pylori by serology, and no history of H. pylori eradication.
4. Subjects must have history of GERD with or without antacid use.
5. Subjects must be able to tolerate nasogastric tube placement.

Exclusion Criteria

1. History of gastric surgery, fundoplication or vagotomy.
2. Pyloric stenosis Barrett's esophagus or esophageal stricture.
3. Treatment with a histamine H2-receptor antagonist, prostaglandin, or sucralfate within 14 days before enrollment into this study.
4. Treatment with rabeprazole, omeprazole, lansoprazole, pantoprazole, esomeprazole, prokinetic agent, or bismuth subsalicylate within 30 days before enrollment into this study.
5. Concurrent serious systemic disorders, including renal insufficiency and hepatic insufficiency.
6. Subjects with neoplasia or undergoing treatment for cancer (e.g., chemotherapy, radiation.
7. Any condition associated with poor subject compliance (e.g., alcohol abuse, drug abuse).
8. History of clinically significant abuse of alcohol defined as (1) patterns of alcohol intake consistent with disruption of normal function in society; (2) history of, or current existence of any indication of difficulty in abstaining from alcohol for the required duration of the present protocol; (3) use of any alcohol within one day of any study period.
9. Subjects who have received any investigational agent within the previous 30 days.
10. Inability of subject to return for scheduled visits.
11. Subjects who, in the opinion of the investigator, are poor medical or psychiatric risks for therapy with an investigational drug.
12. History of any hypersensitivity reaction to rabeprazole, pantoprazole or any of their inactive ingredients.
13. Any significant evidence at screening of endocrine, cardiovascular, and/or pulmonary disorder.
14. Any predisposing condition that might interfere with the absorption, distribution, metabolism, or excretion of drug, or a history of abnormal bleeding tendencies or thrombophlebitis.
15. History of HIV, hepatitis B, or hepatitis C infection.
16. Subjects who are pregnant or likely to become pregnant during the course of this study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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PriCara, Unit of Ortho-McNeil, Inc.

INDUSTRY

Sponsor Role collaborator

Eisai Inc.

INDUSTRY

Sponsor Role collaborator

VA Greater Los Angeles Healthcare System

FED

Sponsor Role lead

Principal Investigators

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Joseph Pisegna, MD

Role: PRINCIPAL_INVESTIGATOR

VA Greater Los Angeles Healthcare System

Locations

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VA Greater Los Angeles Healthcare System

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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0028

Identifier Type: -

Identifier Source: org_study_id