- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00516971
The Use of Proton Pump Inhibitor for the Treatment of Non-erosive Gastro-oesophageal Reflux Disease in Chinese Population
July 6, 2010 updated by: Hospital Authority, Hong Kong
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Hong Kong, China
- Recruiting
- Queen Mary Hospital
-
Sub-Investigator:
- Kam Chuen Lai, Dr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Symptoms assessment, quality of life.
Time Frame: 12 Weeks
|
12 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Compliance
Time Frame: 8 Weeks
|
8 Weeks
|
Adverse effects
Time Frame: 8 Weeks
|
8 Weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2003
Primary Completion
December 7, 2022
Study Completion (Anticipated)
December 1, 2008
Study Registration Dates
First Submitted
August 15, 2007
First Submitted That Met QC Criteria
August 15, 2007
First Posted (Estimate)
August 16, 2007
Study Record Updates
Last Update Posted (Estimate)
July 7, 2010
Last Update Submitted That Met QC Criteria
July 6, 2010
Last Verified
July 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EC1925-02
- HARECCTR0500031
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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