Status:
COMPLETED
A Study of Rabeprazole and Pantoprazole on Stomach Acid and Esophageal Acid Exposure in Patients With Gastroesophageal Reflux Disease (GERD) and a History of Nighttime Heartburn
Lead Sponsor:
PriCara, Unit of Ortho-McNeil, Inc.
Collaborating Sponsors:
Eisai Inc.
Conditions:
Gastroesophageal Reflux
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The purpose of the study is to compare the pharmacodynamics (the way a drug works in the body) of rabeprazole and pantoprazole on intragastric acidity and esophageal acid exposure in gastroesophageal ...
Detailed Description
The purpose of this study is to compare the effects of a single dose of two drugs, rabeprazole and pantoprazole, on reducing the amount of acid in the stomach and esophagus in subjects with GERD. This...
Eligibility Criteria
Inclusion
- Diagnosis of GERD with symptoms for at least 6 months with at least 3 episodes a week and one of those at nighttime
- in generally good health
- stop any previous similar (proton pump inhibitor) therapy at least 10 days before screening
- weigh within normal weight for one's height
- able to tolerate a nasogastric tube (pH probe assembly that goes through the nose into the stomach) for 48 hours on 2 different occasions
- esophageal acid exposure of at least 10% on a 24-hour pH monitoring study performed within the 24 months prior to screening
- Helicobacter pylori (an infection) negative
- willing to take only TUMS antacid as rescue medicine during the washout period
Exclusion
- History of a serious medical condition
- significant gastrointestinal illness other than GERD
- ulcer at any time in the past
- difficulty swallowing
- history of gastrointestinal disease (including bleeding)
- use of any medication that changes acid secretion or gastrointestinal movement in the past 14 days
- use of any drugs on a list of prohibited drugs within 1 month
- chronic use of pain relieving medications (NSAIDs or COX-2 inhibitors)
- pregnant or breast-feeding
- cancer diagnosis or treatment (except for superficial skin cancers)
- abusing drugs or alcohol
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2005
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00237367
End Date
April 1 2005
Last Update
April 28 2010
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