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

• Sponsor: Hospital Authority, Hong Kong (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00516971
• Collaborator: The University of Hong Kong (Other)
• Enrollment: 200
• Location: 1
• Duration (Months): 71
• Patients Per Site Per Month: 2.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastroesophageal Reflux	Drug: Esomeprazole 20mg once daily	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: The Use of Proton Pump Inhibitor for the Treatment of Non-erosive Gastro-oesophageal Reflux Disease in Chinese Population
• Study Start Date: Jan 1, 2003
• Anticipated Study Completion Date: Dec 1, 2008

Outcome Measures

Primary Outcome Measures

1. Symptoms assessment, quality of life. [12 Weeks]

Secondary Outcome Measures

1. Compliance [8 Weeks]

2. Adverse effects [8 Weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All

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

Locations

	Site	City	State	Country	Postal Code
1	Queen Mary Hospital	Hong Kong		China

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• HAREC Clinical Trial Registry

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00516971
• Other Study ID Numbers: EC1925-02; HARECCTR0500031
• First Posted: Aug 16, 2007
• Last Update Posted: Jul 7, 2010
• Last Verified: Jul 1, 2010

• Keywords provided by , ,: Non-erosive reflux disease
• Additional relevant MeSH terms: Gastroesophageal Reflux; Esomeprazole

Study Results

No Results Posted as of Jul 7, 2010