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

NCT ID: NCT00516971

Last Updated: 2010-07-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-01-31
• Study Completion Date: 2008-12-31

Brief Summary

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.

Conditions

Gastroesophageal Reflux

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Esomeprazole 20mg once daily

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Hong Kong

OTHER

Sponsor Role: collaborator

Hospital Authority, Hong Kong

OTHER_GOV

Sponsor Role: lead

Principal Investigators

Ting Kin Cheung, Dr

Role: PRINCIPAL_INVESTIGATOR

Department of Medicine, The University of Hong Kong

Locations

Queen Mary Hospital

Hong Kong, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Ting Kin Cheung, Dr

Role: CONTACT

cheungtk@hkucc.hku.hk

(852) 2855 3989

Other Identifiers

HARECCTR0500031

Identifier Type: -

Identifier Source: secondary_id

EC1925-02

Identifier Type: -

Identifier Source: org_study_id