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

Primary Purpose

Gastroesophageal Reflux

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Esomeprazole 20mg once daily
Sponsored by
Hospital Authority, Hong Kong
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux focused on measuring Non-erosive reflux disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All Sexes

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.

Sites / Locations

  • Queen Mary HospitalRecruiting

Outcomes

Primary Outcome Measures

Symptoms assessment, quality of life.

Secondary Outcome Measures

Compliance
Adverse effects

Full Information

First Posted
August 15, 2007
Last Updated
July 6, 2010
Sponsor
Hospital Authority, Hong Kong
Collaborators
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT00516971
Brief Title
The Use of Proton Pump Inhibitor for the Treatment of Non-erosive Gastro-oesophageal Reflux Disease in Chinese Population
Official Title
The Use of Proton Pump Inhibitor for the Treatment of Non-erosive Gastro-oesophageal Reflux Disease in Chinese Population
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital Authority, Hong Kong
Collaborators
The University of Hong Kong

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux
Keywords
Non-erosive reflux disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Esomeprazole 20mg once daily
Primary Outcome Measure Information:
Title
Symptoms assessment, quality of life.
Time Frame
12 Weeks
Secondary Outcome Measure Information:
Title
Compliance
Time Frame
8 Weeks
Title
Adverse effects
Time Frame
8 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ting Kin Cheung, Dr
Phone
(852) 2855 3989
Email
cheungtk@hkucc.hku.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ting Kin Cheung, Dr
Organizational Affiliation
Department of Medicine, The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benjamin CY Wong, Dr
First Name & Middle Initial & Last Name & Degree
Kam Chuen Lai, Dr

12. IPD Sharing Statement

Learn more about this trial

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

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