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

Primary Purpose

Gastroesophageal Reflux Disease

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
rabeprazole
pantoprazole
Sponsored by
VA Greater Los Angeles Healthcare System
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux Disease focused on measuring Gastroesophageal Reflux Disease, Proton Pump Inhibitors, Gastric pH, Gastric Acid Secretion

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subjects, 18-65 years of age, inclusive, male or female, of any race, who are willing to undergo testing at the study center. 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. Subjects must have a negative result on the screening for H. pylori by serology, and no history of H. pylori eradication. Subjects must have history of GERD with or without antacid use. Subjects must be able to tolerate nasogastric tube placement. Exclusion Criteria: History of gastric surgery, fundoplication or vagotomy. Pyloric stenosis Barrett's esophagus or esophageal stricture. Treatment with a histamine H2-receptor antagonist, prostaglandin, or sucralfate within 14 days before enrollment into this study. Treatment with rabeprazole, omeprazole, lansoprazole, pantoprazole, esomeprazole, prokinetic agent, or bismuth subsalicylate within 30 days before enrollment into this study. Concurrent serious systemic disorders, including renal insufficiency and hepatic insufficiency. Subjects with neoplasia or undergoing treatment for cancer (e.g., chemotherapy, radiation. Any condition associated with poor subject compliance (e.g., alcohol abuse, drug abuse). 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. Subjects who have received any investigational agent within the previous 30 days. Inability of subject to return for scheduled visits. Subjects who, in the opinion of the investigator, are poor medical or psychiatric risks for therapy with an investigational drug. History of any hypersensitivity reaction to rabeprazole, pantoprazole or any of their inactive ingredients. Any significant evidence at screening of endocrine, cardiovascular, and/or pulmonary disorder. Any predisposing condition that might interfere with the absorption, distribution, metabolism, or excretion of drug, or a history of abnormal bleeding tendencies or thrombophlebitis. History of HIV, hepatitis B, or hepatitis C infection. Subjects who are pregnant or likely to become pregnant during the course of this study.

Sites / Locations

  • VA Greater Los Angeles Healthcare System

Outcomes

Primary Outcome Measures

To test the hypothesis that during the hours 2000 through 0800 following a single dose administration of medication, the median change from baseline values in gastric acid secretion with 20 mg rabeprazole is significantly less than 40 mg pantoprazole

Secondary Outcome Measures

Full Information

First Posted
March 16, 2006
Last Updated
September 14, 2007
Sponsor
VA Greater Los Angeles Healthcare System
Collaborators
PriCara, Unit of Ortho-McNeil, Inc., Eisai Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00304421
Brief Title
Comparison of the Nighttime Effects of Two Different Drugs on Subjects With GERD
Official Title
Comparison of the Nighttime Effects of Rabeprazole 20 mg to Pantoprazole 40 mg on Standard Meal Stimulated Gastric Acid Secretion and Intragastric pH in H. Pylori Negative Volunteer Subjects With GERD
Study Type
Interventional

2. Study Status

Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
VA Greater Los Angeles Healthcare System
Collaborators
PriCara, Unit of Ortho-McNeil, Inc., Eisai Inc.

4. Oversight

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease
Keywords
Gastroesophageal Reflux Disease, Proton Pump Inhibitors, Gastric pH, Gastric Acid Secretion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
23 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
rabeprazole
Intervention Type
Drug
Intervention Name(s)
pantoprazole
Primary Outcome Measure Information:
Title
To test the hypothesis that during the hours 2000 through 0800 following a single dose administration of medication, the median change from baseline values in gastric acid secretion with 20 mg rabeprazole is significantly less than 40 mg pantoprazole

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects, 18-65 years of age, inclusive, male or female, of any race, who are willing to undergo testing at the study center. 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. Subjects must have a negative result on the screening for H. pylori by serology, and no history of H. pylori eradication. Subjects must have history of GERD with or without antacid use. Subjects must be able to tolerate nasogastric tube placement. Exclusion Criteria: History of gastric surgery, fundoplication or vagotomy. Pyloric stenosis Barrett's esophagus or esophageal stricture. Treatment with a histamine H2-receptor antagonist, prostaglandin, or sucralfate within 14 days before enrollment into this study. Treatment with rabeprazole, omeprazole, lansoprazole, pantoprazole, esomeprazole, prokinetic agent, or bismuth subsalicylate within 30 days before enrollment into this study. Concurrent serious systemic disorders, including renal insufficiency and hepatic insufficiency. Subjects with neoplasia or undergoing treatment for cancer (e.g., chemotherapy, radiation. Any condition associated with poor subject compliance (e.g., alcohol abuse, drug abuse). 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. Subjects who have received any investigational agent within the previous 30 days. Inability of subject to return for scheduled visits. Subjects who, in the opinion of the investigator, are poor medical or psychiatric risks for therapy with an investigational drug. History of any hypersensitivity reaction to rabeprazole, pantoprazole or any of their inactive ingredients. Any significant evidence at screening of endocrine, cardiovascular, and/or pulmonary disorder. Any predisposing condition that might interfere with the absorption, distribution, metabolism, or excretion of drug, or a history of abnormal bleeding tendencies or thrombophlebitis. History of HIV, hepatitis B, or hepatitis C infection. Subjects who are pregnant or likely to become pregnant during the course of this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Pisegna, MD
Organizational Affiliation
VA Greater Los Angeles Healthcare System
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Greater Los Angeles Healthcare System
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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