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NCT00539786 Clinical Trial

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

Gastroesophageal Reflux Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00539786
Other study ID # 2006-03-071
Secondary ID
Status Recruiting
Phase N/A
First received October 3, 2007
Last updated May 14, 2014
Start date March 2006

Study information
Verified date May 2014
Source Samsung Medical Center
Contact Tae ggon Kim
Phone +82-2-3410-2975
Email tggo.kim@samsung.com
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date
Est. primary completion date April 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 75 Years
Eligibility 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

Study Design

Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Korea, Republic of Samsung Medical Center, Sungkyunkwan University School of Medicine Seoul Gangnam-gu

Sponsors (1)
Lead Sponsor Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Symptom responders after PPI trials 2 weeks after PPI trials No
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