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

Gastroesophageal Reflux Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00516971
• Other study ID #: EC1925-02
• Secondary ID: HARECCTR0500031
• Status: Recruiting
• Phase: N/A
• First received: August 15, 2007
• Last updated: July 6, 2010
• Start date: January 2003
• Est. completion date: December 2008

Study information

• Verified date: July 2010
• Source: Hospital Authority, Hong Kong
• Contact: Ting Kin Cheung, Dr
• Phone: (852) 2855 3989
• Email: cheungtk[@]hkucc.hku.hk
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2008
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux

Intervention

Drug:
• Esomeprazole 20mg once daily

Locations

Country	Name	City	State
China	Queen Mary Hospital	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Authority, Hong Kong	The University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptoms assessment, quality of life.		12 Weeks
Secondary	Compliance		8 Weeks
Secondary	Adverse effects		8 Weeks

External Links

•   HAREC Clinical Trial Registry