- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00164840
Symptomatic Gastroesophageal Reflux Disease: Double Blind Randomized Controlled Study of On-demand Therapy Versus Maintenance Therapy
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Hong Kong, China
- Endoscopy Centre, Prince of Wales Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Treatment failure
Time Frame: 26 Weeks
|
26 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Quality of Life
Time Frame: 1 year
|
1 year
|
Symptom score
Time Frame: 26 weeks
|
26 weeks
|
Number of days off treatment
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Gastrointestinal Diseases
- Stomach Diseases
- Gastroenteritis
- Intestinal Diseases
- Esophageal Motility Disorders
- Deglutition Disorders
- Esophageal Diseases
- Esophagitis
- Peptic Ulcer
- Duodenal Diseases
- Gastroesophageal Reflux
- Esophagitis, Peptic
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Gastrointestinal Agents
- Anti-Ulcer Agents
- Proton Pump Inhibitors
- Esomeprazole
Other Study ID Numbers
- OG Study
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.
Clinical Trials on Gastroesophageal Reflux Disease
-
TakedaTerminatedGastroesophageal Reflux Disease | Non-erosive Reflux DiseaseSwitzerland, Netherlands
-
Vanderbilt University Medical CenterCompletedGastroesophageal Reflux Disease (GERD) | Non-erosive Reflux Disease (NERD)United States
-
Mansoura UniversityWithdrawnGastroesophageal Reflux Disease
-
Cliniques universitaires Saint-Luc- Université...UnknownGastroesophageal Reflux DiseaseBelgium
-
GlaxoSmithKlineCompletedReflux, Gastroesophageal | Gastroesophageal Reflux DiseaseAustralia
-
King Chulalongkorn Memorial HospitalCompleted
-
University of North Carolina, Chapel HillNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedGastroesophageal Reflux Disease | GERD | Acid Reflux | RefluxUnited States
-
PfizerTerminatedGastroesophageal Reflux DiseaseBrazil, Germany, Korea, Republic of, Belgium, Spain, Slovakia, France
-
GlaxoSmithKlineCompletedReflux, Gastroesophageal | Gastroesophageal Reflux DiseaseAustralia
-
Duke UniversityNational Heart, Lung, and Blood Institute (NHLBI)CompletedGastroesophageal Reflux Disease (GERD) | RefluxUnited States, Canada
Clinical Trials on Esomeprazole
-
TakedaCompletedHealthy ParticipantsUnited States
-
National Taiwan University HospitalMinistry of Science and Technology, Taipei, TaiwanCompleted
-
AstraZenecaCompletedRefractory Reflux EsophagitisJapan
-
Chinese University of Hong KongCompletedBleeding | Peptic UlcerChina
-
Bio-innova Co., LtdNot yet recruiting
-
Onconic Therapeutics Inc.Completed
-
Bio-innova Co., LtdNot yet recruiting
-
Chong Kun Dang PharmaceuticalCompleted
-
AstraZenecaCompletedGastroesophageal Reflux Disease (GERD)United States, France, Poland, Germany
-
Chinese University of Hong KongTerminatedGastrointestinal HemorrhageChina