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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00304421
Recruitment Status : Completed
First Posted : March 17, 2006
Last Update Posted : September 17, 2007
PriCara, Unit of Ortho-McNeil, Inc.
Eisai Inc.
Information provided by:
VA Greater Los Angeles Healthcare System

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.

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Disease Drug: rabeprazole Drug: pantoprazole Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : January 2004
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Primary Outcome Measures :
  1. 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

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00304421

United States, California
VA Greater Los Angeles Healthcare System
Los Angeles, California, United States, 90073
Sponsors and Collaborators
VA Greater Los Angeles Healthcare System
PriCara, Unit of Ortho-McNeil, Inc.
Eisai Inc.
Principal Investigator: Joseph Pisegna, MD VA Greater Los Angeles Healthcare System Identifier: NCT00304421     History of Changes
Other Study ID Numbers: 0028
First Posted: March 17, 2006    Key Record Dates
Last Update Posted: September 17, 2007
Last Verified: September 2007

Keywords provided by VA Greater Los Angeles Healthcare System:
Gastroesophageal Reflux Disease
Proton Pump Inhibitors
Gastric pH
Gastric Acid Secretion

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action