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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00516971

Enrollment

200

Registered

2007-08-16

Start date

2003-01-31

Completion date

2008-12-31

Last updated

2010-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal Reflux

Keywords

Non-erosive reflux disease

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.

Interventions

DRUGEsomeprazole 20mg once daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame
Symptoms assessment, quality of life.	12 Weeks

Secondary

Measure	Time frame
Compliance	8 Weeks
Adverse effects	8 Weeks

Countries

China

Contacts

Primary ContactTing Kin Cheung, Dr

cheungtk@hkucc.hku.hk(852) 2855 3989

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026