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Rabeprazole in Subjects With Gastroesophageal Reflux Disease (GERD)

This study has been completed.
Sponsor:
Collaborators:
PriCara, Unit of Ortho-McNeil, Inc.
Eisai Inc.
Information provided by:
University of Kansas
ClinicalTrials.gov Identifier:
NCT00222170
First received: September 13, 2005
Last updated: May 7, 2009
Last verified: August 2007
History of Changes
  Purpose

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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Kansas:

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

Enrollment: 24
Study Start Date: May 2005
Study Completion Date: May 2007
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

Ages Eligible for Study:   19 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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").

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00222170

Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas
PriCara, Unit of Ortho-McNeil, Inc.
Eisai Inc.
Investigators
Principal Investigator: Jerzy Sarosiek, PhD University of Kansas
Principal Investigator: Mojtaba S. Olyaee, MD University of Kansas
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00222170     History of Changes
Other Study ID Numbers: RE Study
Study First Received: September 13, 2005
Last Updated: May 7, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Esophageal Diseases
Gastroesophageal Reflux
Gastrointestinal Diseases
Digestive System Diseases
Esophageal Motility Disorders
Deglutition Disorders
Rabeprazole
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013