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The Proton Pump Inhibitor (PPI) Test for the Extraesophageal Manifestation of GERD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00539786
Recruitment Status : Unknown
Verified May 2014 by Poong-Lyul Rhee, Samsung Medical Center.
Recruitment status was:  Recruiting
First Posted : October 5, 2007
Last Update Posted : May 16, 2014
Sponsor:
Information provided by (Responsible Party):
Poong-Lyul Rhee, Samsung Medical Center

Brief Summary:
PPI test;empirical trial with high-dose proton-pump inhibitors (PPIs) has been shown to be a sensitive tool for diagnosing patients with GERD. However, this diagnostic strategy has not been well established in patients with extraesophageal manifestation of GERD. In this study, we aim to see the relevance of PPI test in diagnosing GERD in patients with extraesophageal symptoms.

Condition or disease Intervention/treatment
Gastroesophageal Reflux Disease Drug: Proton pump inhibitor (rabeprazole)

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Clinical Usefulness of Proton Pump Inhibitor Test for Identifying Gastroesophageal Reflux Disease in Patients With Extraesophageal Symptoms
Study Start Date : March 2006
Primary Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD
U.S. FDA Resources


Intervention Details:
    Drug: Proton pump inhibitor (rabeprazole)
    Patients receives rabeprazole 20mg AM and 20mg PM for 14 days


Primary Outcome Measures :
  1. Symptom responders after PPI trials [ Time Frame: 2 weeks after PPI trials ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with extraesophageal manifestation symptoms of GERD

Exclusion Criteria:

  • laryngeal, pharyngeal, liver, lung, renal, or hematological disorders
  • a history of gastrointestinal surgery, and a history of connective tissue disorders.
  • patients with duodenal or gastric ulcers as well as other significant lesions, such as gastric cancer, esophageal cancer, or subepithelial tumors more than 1 cm observed on the upper endoscopy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00539786


Contacts
Contact: Tae ggon Kim +82-2-3410-2975 tggo.kim@samsung.com

Locations
Korea, Republic of
Samsung Medical Center, Sungkyunkwan University School of Medicine Recruiting
Seoul, Gangnam-gu, Korea, Republic of, 135-710
Contact: Poong Lyul Rhee, M.D., Ph.D    +82-2-3410-3409    plrhee@skku.edu   
Principal Investigator: Poong-Lyul Rhee, M.D., Ph.D.         
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Poong-Lyul Rhee, MD. Ph.D Samsung Medical Center, Sungkyunkwan University School of Medicine

Responsible Party: Poong-Lyul Rhee, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00539786     History of Changes
Other Study ID Numbers: 2006-03-071
First Posted: October 5, 2007    Key Record Dates
Last Update Posted: May 16, 2014
Last Verified: May 2014

Keywords provided by Poong-Lyul Rhee, Samsung Medical Center:
Patients with extraesophageal manifestation of gastroesophageal reflux disease

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