Back to resultsThe Proton Pump Inhibitor (PPI) Test for the Extraesophageal Manifestation of GERD
Primary Purpose
Gastroesophageal Reflux Disease
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Proton pump inhibitor (rabeprazole)
Sponsored by
About this trial
This is an interventional diagnostic trial for Gastroesophageal Reflux Disease focused on measuring Patients with extraesophageal manifestation of gastroesophageal reflux disease
Eligibility 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
Sites / Locations
- Samsung Medical Center, Sungkyunkwan University School of MedicineRecruiting
Outcomes
Primary Outcome Measures
Symptom responders after PPI trials
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00539786
Brief Title
The Proton Pump Inhibitor (PPI) Test for the Extraesophageal Manifestation of GERD
Official Title
Clinical Usefulness of Proton Pump Inhibitor Test for Identifying Gastroesophageal Reflux Disease in Patients With Extraesophageal Symptoms
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2006 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease
Keywords
Patients with extraesophageal manifestation of gastroesophageal reflux disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Proton pump inhibitor (rabeprazole)
Intervention Description
Patients receives rabeprazole 20mg AM and 20mg PM for 14 days
Primary Outcome Measure Information:
Title
Symptom responders after PPI trials
Time Frame
2 weeks after PPI trials
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tae ggon Kim
Phone
+82-2-3410-2975
Email
tggo.kim@samsung.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Poong-Lyul Rhee, MD. Ph.D
Organizational Affiliation
Samsung Medical Center, Sungkyunkwan University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center, Sungkyunkwan University School of Medicine
City
Seoul
State/Province
Gangnam-gu
ZIP/Postal Code
135-710
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Poong Lyul Rhee, M.D., Ph.D
Phone
+82-2-3410-3409
Email
plrhee@skku.edu
First Name & Middle Initial & Last Name & Degree
Poong-Lyul Rhee, M.D., Ph.D.
12. IPD Sharing Statement
Learn more about this trial
The Proton Pump Inhibitor (PPI) Test for the Extraesophageal Manifestation of GERD
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