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

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...

Date First Received: October 3, 2007

Last Updated: October 4, 2007

Verified by: Samsung Medical Center, March 2006

Clinical Trial Phase: N/A | Start Date: March 2006

Overall Status: Recruiting

Brief Summary

Official Title: “Clinical Usefulness of Proton Pump Inhibitor Test for Identifying Gastroesophageal Reflux Disease in Patients With Extraesophageal Symptoms”

Condition Keyword(s):

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.

Study Type: Interventional

Study Design: Diagnostic, Open Label, Parallel Assignment

Intervention(s) in this Clinical Trial

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

Outcome Measures for this Clinical Trial

Primary Measures

  • Symptom responders after PPI trials

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 75 Years

Clinical Trial Sponsor Information

Lead Sponsor: Samsung Medical Center

Overall Clinical Trial Officials and Contacts

Poong-Lyul Rhee, MD. Ph.D Principal Investigator Samsung Medical Center, Sungkyunkwan University School of Medicine  

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

Additional Information

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00539786

Study ID Number: 2006-03-071

ClinicalTrials.gov Identifier: NCT00539786

Health Authority: Korea: Food and Drug Administration

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