The Use of Proton Pump Inhibitor for the Treatment of Non-Erosive Gastro-Oesophageal Reflux Disease in Chinese Population - Full Text View

The Use of Proton Pump Inhibitor for the Treatment of Non-Erosive Gastro-Oesophageal Reflux Disease in Chinese Population

This study is currently recruiting participants.
Verified by Hospital Authority, Hong Kong, June 2008

Sponsors and Collaborators:	Hospital Authority, Hong Kong The University of Hong Kong
Information provided by:	Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier:	NCT00516971

Purpose

The purpose of this study is to evaluate the efficacy of proton pump inhibitor for the treatment of non-erosive reflux disease (NERD) in Chinese population. Studies from the western population have estimated a worldwide prevalence of gastro-oesophageal reflux disease from 10 to 20 %. Monthly symptoms of heartburn or acid regurgitation were found in 9.3% of subjects according to a population survey in Hong Kong. Most of these patients did not show evidence of erosive change during upper endoscopy. However, patients with NERD suffer from similar impairment of quality of life as patients with erosive oesophagitis and their symptoms are as severe as patients with erosive disease. Data on the use of proton pump inhibitor for the treatment of NERD in Chinese patients are scanty. Thus we want to perform a double-blind randomised placebo-controlled study to evaluate the efficacy of proton pump inhibitor for the treatment of NERD in Chinese population.

Condition	Intervention
Gastroesophageal Reflux	Drug: Esomeprazole 20mg once daily

MedlinePlus related topics:

Esophagus Disorders GERD

ChemIDplus related topics:

Esomeprazole magnesium Esomeprazole Sodium Omeprazole Omeprazole magnesium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	The Use of Proton Pump Inhibitor for the Treatment of Non-Erosive Gastro-Oesophageal Reflux Disease in Chinese Population

Further study details as provided by Hospital Authority, Hong Kong:

Primary Outcome Measures:

Symptoms assessment, quality of life. [ Time Frame: 12 Weeks ]

Secondary Outcome Measures:

Compliance [ Time Frame: 8 Weeks ]
Adverse effects [ Time Frame: 8 Weeks ]

Estimated Enrollment:	200
Study Start Date:	January 2003
Estimated Study Completion Date:	December 2008

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Ambulatory patients with age between 18 -80 years old,
Patients with predominant symptoms of heartburn or acid regurgitation at least once weekly with no evidence of endoscopic pathology.

Exclusion Criteria:

Patients under 18 or over 80 years of age,
Symptoms of gastrointestinal bleeding,
Patients who had previous upper gastrointestinal surgery,
Patients with concomitant serious medical diseases,
Patients who had received H2-receptor antagonists or proton pump inhibitors in the past 4 weeks,
Pregnant or lactating women.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00516971

Contacts


Contact: Ting Kin Cheung, Dr	(852) 2855 3989	cheungtk@hkucc.hku.hk

Locations


China
	Queen Mary Hospital	Recruiting
	Hong Kong, China
	Sub-Investigator: Benjamin CY Wong, Dr
	Sub-Investigator: Kam Chuen Lai, Dr

Sponsors and Collaborators

Hospital Authority, Hong Kong

The University of Hong Kong

Investigators


Principal Investigator:	Ting Kin Cheung, Dr	Department of Medicine, The University of Hong Kong

More Information

HAREC Clinical Trial Registry This link exits the ClinicalTrials.gov site

Study ID Numbers:	EC1925-02, HARECCTR0500031
First Received:	August 15, 2007
Last Updated:	June 16, 2008
ClinicalTrials.gov Identifier:	NCT00516971
Health Authority:	Hong Kong: Ethics Committee

Keywords provided by Hospital Authority, Hong Kong:

Non-erosive reflux disease

Study placed in the following topic categories:

Deglutition Disorders

Esophageal Motility Disorders

Digestive System Diseases

Esophageal disorder

Gastrointestinal Diseases

Omeprazole

Esophageal Diseases

Gastroesophageal Reflux

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Anti-Ulcer Agents

Gastrointestinal Agents

Enzyme Inhibitors

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 07, 2008