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

Gastroesophageal Reflux Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00304421
• Other study ID #: 0028
• Status: Completed
• Phase: Phase 4
• First received: March 16, 2006
• Last updated: September 14, 2007
• Start date: January 2004
• Est. completion date: September 2007

Study information

• Verified date: September 2007
• Source: VA Greater Los Angeles Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

Drug:
• rabeprazole

• pantoprazole

Locations

Country	Name	City	State
United States	VA Greater Los Angeles Healthcare System	Los Angeles	California

Sponsors (3)

Lead Sponsor	Collaborator
VA Greater Los Angeles Healthcare System	Eisai Inc., PriCara, Unit of Ortho-McNeil, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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