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

• Sponsor: Samsung Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00539786
• Collaborator: (none)
• Enrollment: 100
• Location: 1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Gastroesophageal Reflux Disease	Drug: Proton pump inhibitor (rabeprazole)	N/A

Study Design

• Study Type: Interventional
• Anticipated 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: Mar 1, 2006
• Actual Primary Completion Date: Apr 1, 2011

Outcome Measures

Primary Outcome Measures

1. Symptom responders after PPI trials [2 weeks after PPI trials]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center, Sungkyunkwan University School of Medicine	Seoul	Gangnam-gu	Korea, Republic of	135-710

Sponsors and Collaborators

• Samsung Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Poong-Lyul Rhee, Professor, Samsung Medical Center
• ClinicalTrials.gov Identifier: NCT00539786
• Other Study ID Numbers: 2006-03-071
• First Posted: Oct 5, 2007
• Last Update Posted: May 16, 2014
• Last Verified: May 1, 2014

• Keywords provided by Poong-Lyul Rhee, Professor, Samsung Medical Center: Patients with extraesophageal manifestation of gastroesophageal reflux disease
• Additional relevant MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic; Rabeprazole; Proton Pump Inhibitors

Study Results

No Results Posted as of May 16, 2014