|
|
|
|
|
|
Sponsors and Collaborators: |
University of Kansas PriCara, Unit of Ortho-McNeil, Inc. Eisai Inc. |
Information provided by: | University of Kansas |
ClinicalTrials.gov Identifier: | NCT00222170 |
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.
Condition | Intervention | Phase |
Esophageal Reflux |
Drug: Rabeprazole |
Phase II |
MedlinePlus related topics: | Esophagus Disorders GERD |
ChemIDplus related topics: | E 3810 |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Crossover Assignment |
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) |
Enrollment: | 24 |
Study Start Date: | May 2005 |
Study Completion Date: | May 2007 |
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.
Ages Eligible for Study: | 19 Years to 79 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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").
United States, Kansas | |||||
University of Kansas Medical Center | |||||
Kansas City, Kansas, United States, 66160 |
University of Kansas |
PriCara, Unit of Ortho-McNeil, Inc. |
Eisai Inc. |
Principal Investigator: | Jerzy Sarosiek, PhD | University of Kansas |
Principal Investigator: | Mojtaba S. Olyaee, MD | University of Kansas |
Study ID Numbers: | RE Study |
First Received: | September 13, 2005 |
Last Updated: | August 1, 2007 |
ClinicalTrials.gov Identifier: | NCT00222170 |
Health Authority: | United States: Food and Drug Administration |
|
|
|
|