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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Samsung Medical Center
Sponsor:
Information provided by (Responsible Party):
Poong-Lyul Rhee, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT00539786
First received: October 3, 2007
Last updated: May 14, 2014
Last verified: May 2014
  Purpose

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 Intervention
Gastroesophageal Reflux Disease
Drug: Proton pump inhibitor (rabeprazole)

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Clinical Usefulness of Proton Pump Inhibitor Test for Identifying Gastroesophageal Reflux Disease in Patients With Extraesophageal Symptoms

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Symptom responders after PPI trials [ Time Frame: 2 weeks after PPI trials ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: March 2006
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Proton pump inhibitor (rabeprazole)
    Patients receives rabeprazole 20mg AM and 20mg PM for 14 days
  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Poong-Lyul Rhee, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00539786     History of Changes
Other Study ID Numbers: 2006-03-071
Study First Received: October 3, 2007
Last Updated: May 14, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by 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
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014