Comparison of the Nighttime Effects of Two Different Drugs on Subjects With GERD (NCT00304421) | Clinical Trial Compass
CompletedPhase 4
Comparison of the Nighttime Effects of Two Different Drugs on Subjects With GERD
United States23 participantsStarted 2004-01
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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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.
What they're measuring
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
. 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.