Symptomatic Gastroesophageal Reflux Disease: Double Blind Randomized Controlled Study of On-demand Therapy Versus Maintenance Therapy
Primary Purpose
Gastroesophageal Reflux Disease
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Esomeprazole
Sponsored by
About this trial
This is an interventional treatment trial for Gastroesophageal Reflux Disease focused on measuring GERD
Eligibility Criteria
Inclusion Criteria: Weekly symptoms of heartburn or acid regurgitation of moderate severity as predominant complaint for at least 6 months Exclusion Criteria: Erosive esophagitis Concomitant peptic ulcer disease Use of NSAID in recent 4 weeks (Low dose aspirin < 300 mg is allowed) Pregnant or lactating female Illiterate patient (who cannot administer questionnaire) Known hypersensitivity to PPI
Sites / Locations
- Endoscopy Centre, Prince of Wales Hospital
Outcomes
Primary Outcome Measures
Treatment failure
Secondary Outcome Measures
Symptom score
Quality of Life
Number of days off treatment
Full Information
NCT ID
NCT00164840
First Posted
September 9, 2005
Last Updated
March 29, 2010
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT00164840
Brief Title
Symptomatic Gastroesophageal Reflux Disease: Double Blind Randomized Controlled Study of On-demand Therapy Versus Maintenance Therapy
Official Title
Symptomatic Gastroesophageal Reflux Disease: Double Blind Randomized Controlled Study of On-demand Therapy Versus Maintenance Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
5. Study Description
Brief Summary
Maintenance treatment with proton pump inhibitor (PPI) is the most widely recommended modality of treatment for long-term management of gastroesophageal reflux disease (GERD). Yet in clinical practice treatment is commonly given in short courses on as required basis during symptom flare up, particularly for patients with mild to moderate GERD.
On-demand therapy also has the potential advantage that patient does not need to take regular medications, thereby improving the quality of life. However, whether on-demand PPI therapy achieves similar efficacy of symptom control is uncertain.
The aim of this study is to compare the efficacy and quality of life of on-demand and maintenance PPI regimens in long-term management of non-erosive GERD patients. The investigators hypothesize that on-demand PPI treatment is as effective as maintenance PPI.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease
Keywords
GERD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
244 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Esomeprazole
Primary Outcome Measure Information:
Title
Treatment failure
Time Frame
26 Weeks
Secondary Outcome Measure Information:
Title
Symptom score
Time Frame
26 weeks
Title
Quality of Life
Time Frame
1 year
Title
Number of days off treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Weekly symptoms of heartburn or acid regurgitation of moderate severity as predominant complaint for at least 6 months
Exclusion Criteria:
Erosive esophagitis
Concomitant peptic ulcer disease
Use of NSAID in recent 4 weeks (Low dose aspirin < 300 mg is allowed)
Pregnant or lactating female
Illiterate patient (who cannot administer questionnaire)
Known hypersensitivity to PPI
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Justin CY WU, MD
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Endoscopy Centre, Prince of Wales Hospital
City
Hong Kong
Country
China
12. IPD Sharing Statement
Learn more about this trial
Symptomatic Gastroesophageal Reflux Disease: Double Blind Randomized Controlled Study of On-demand Therapy Versus Maintenance Therapy
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