Rabeprazole in Subjects With Gastroesophageal Reflux Disease (GERD)
Information source: University of Kansas
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Esophageal Reflux
Intervention: Rabeprazole (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: University of Kansas Official(s) and/or principal investigator(s):
Jerzy Sarosiek, PhD, Principal Investigator, Affiliation: University of Kansas
Mojtaba S. Olyaee, MD, Principal Investigator, Affiliation: University of Kansas
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.
Clinical Details
Official title: Esophagoprotection by Rabeprazole Mediated by Restoration of an Impairment in Esophageal Mucin Production: Its Potential Therapeutic Benefit in Patients With Gastroesophageal Reflux Disease (GERD)
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Crossover Assignment
Primary outcome: Measure of concentration and output of esophageal mucus in esophageal secretion before and after 8 weeks of therapy with rabeprazole
Secondary outcome: Esophageal mucin measurement comparisons on samples collected before and after rabeprazole therapy
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 healing of reflux esophagitis. In patients with completely
healed reflux esophagitis the second collection of salivary and esophageal secretion will be
implemented. In both secretions, adequately coded for the laboratory Research Fellow
(blinded in terms of which sample is collected before and which after treatment with
rabeprazole) the content of mucin will be measured using commercially available assay and its
secretion expressed in units per minute of collection time.
Eligibility
Minimum age: 19 Years.
Maximum age: 79 Years.
Gender(s): Both.
Criteria:
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").
Locations and Contacts
University of Kansas Medical Center, Kansas City, Kansas 66160, United States
Additional Information
Starting date: May 2005
Ending date: May 2007
Last updated: August 1, 2007
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