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

NCT00516971 | Unknown

• 2 other identifiers: EC1925-02HARECCTR0500031
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

Non-erosive reflux disease

Outcome Measures

Primary Outcomes (1)

• Symptoms assessment, quality of life.

  12 Weeks

Secondary Outcomes (2)

• Compliance

  8 Weeks

• Adverse effects

  8 Weeks

Interventions

Esomeprazole 20mg once daily DRUG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Authority, Hong Kong: lead
• The University of Hong Kong: collaborator

Study Sites (1)

Queen Mary Hospital

Hong Kong, China

RECRUITING

MeSH Terms

Conditions

Gastroesophageal Reflux; Non-Erosive Reflux Disease

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Ting Kin Cheung, Dr

  Department of Medicine, The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ting Kin Cheung, Dr

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: August 15, 2007
• First Posted: August 16, 2007
• Study Start: January 1, 2003
• Study Completion: December 1, 2008
• Last Updated: July 7, 2010

Record last verified: 2010-07

Locations

CN (1)