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Rabeprazole in Subjects With Gastroesophageal Reflux Disease (GERD)

Primary Purpose

Esophageal Reflux

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Rabeprazole
Sponsored by
University of Kansas
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Reflux

Eligibility Criteria

19 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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").

Sites / Locations

  • University of Kansas Medical Center

Outcomes

Primary Outcome Measures

Measure of concentration and output of esophageal mucus in esophageal secretion before and after 8 weeks of therapy with rabeprazole

Secondary Outcome Measures

Esophageal mucin measurement comparisons on samples collected before and after rabeprazole therapy

Full Information

First Posted
September 13, 2005
Last Updated
May 7, 2009
Sponsor
University of Kansas
Collaborators
PriCara, Unit of Ortho-McNeil, Inc., Eisai Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00222170
Brief Title
Rabeprazole in Subjects With Gastroesophageal Reflux Disease (GERD)
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 Type
Interventional

2. Study Status

Record Verification Date
August 2007
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Kansas
Collaborators
PriCara, Unit of Ortho-McNeil, Inc., Eisai Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Reflux

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Rabeprazole
Primary Outcome Measure Information:
Title
Measure of concentration and output of esophageal mucus in esophageal secretion before and after 8 weeks of therapy with rabeprazole
Secondary Outcome Measure Information:
Title
Esophageal mucin measurement comparisons on samples collected before and after rabeprazole therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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").
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jerzy Sarosiek, PhD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mojtaba S. Olyaee, MD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States

12. IPD Sharing Statement

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Rabeprazole in Subjects With Gastroesophageal Reflux Disease (GERD)

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