Status:
COMPLETED
Rabeprazole in Subjects With Gastroesophageal Reflux Disease (GERD)
Lead Sponsor:
University of Kansas
Collaborating Sponsors:
PriCara, Unit of Ortho-McNeil, Inc.
Eisai Inc.
Conditions:
Esophageal Reflux
Eligibility:
All Genders
19-79 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the production of mucin in GERD/RE subjects before and after 8 weeks of treatment with rabeprazole.
Detailed Description
Enrolled patients will undergo collection of salivary and esophageal secretions. Subsequently, all patients will receive rabeprazole (20mg QD) for 8 weeks and will be re-endoscoped to confirm complete...
Eligibility Criteria
Inclusion
- Inclusion criteria: 24 patients with endoscopically confirmed reflux esophagitis (Grades A-D according to LA classification) in patients with chronic symptoms of GERD (heartburn with or without regurgitation) between the age of 19 and 79, 12M \& 12F, will be included.
- Exclusion criteria: History of GI surgery, primary esophageal motor disorders, any systemic disease, history of drug or alcohol abuse, pregnancy or nursing, allergy to the same drug class as rabeprazole, the need for any concurrent therapy that affects salivary secretion (causing so-called "dry mouth syndrome").
Exclusion
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00222170
Start Date
May 1 2005
End Date
May 1 2007
Last Update
May 8 2009
Active Locations (1)
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1
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160