Symptomatic Gastroesophageal Reflux Disease: Double Blind Randomized Controlled Study of On-demand Therapy Versus Maintenance Therapy
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|ClinicalTrials.gov Identifier: NCT00164840|
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : March 30, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Gastroesophageal Reflux Disease||Drug: Esomeprazole||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||244 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Symptomatic Gastroesophageal Reflux Disease: Double Blind Randomized Controlled Study of On-demand Therapy Versus Maintenance Therapy|
|Study Start Date :||May 2003|
|Actual Primary Completion Date :||November 2008|
|Actual Study Completion Date :||November 2008|
- Treatment failure [ Time Frame: 26 Weeks ]
- Symptom score [ Time Frame: 26 weeks ]
- Quality of Life [ Time Frame: 1 year ]
- Number of days off treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00164840
|Endoscopy Centre, Prince of Wales Hospital|
|Hong Kong, China|
|Principal Investigator:||Justin CY WU, MD||Chinese University of Hong Kong|