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

This study has been completed.
Sponsor:
Collaborators:
PriCara, Unit of Ortho-McNeil, Inc.
Eisai Inc.
Information provided by:
VA Greater Los Angeles Healthcare System
ClinicalTrials.gov Identifier:
NCT00304421
First received: March 16, 2006
Last updated: September 14, 2007
Last verified: September 2007
  Purpose

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 Intervention Phase
Gastroesophageal Reflux Disease
Drug: rabeprazole
Drug: pantoprazole
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by VA Greater Los Angeles Healthcare System:

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

Estimated Enrollment: 23
Study Start Date: January 2004
Study Completion Date: September 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00304421

Locations
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.
Investigators
Principal Investigator: Joseph Pisegna, MD VA Greater Los Angeles Healthcare System
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00304421     History of Changes
Other Study ID Numbers: 0028
Study First Received: March 16, 2006
Last Updated: September 14, 2007
Health Authority: United States: Federal Government

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
Pantoprazole
Proton Pump Inhibitors
Rabeprazole
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014