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patients could not be recuited within study duration
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To the best of our knowledge, there has been no randomized controlled trial to compare double dose PPI therapy with standard one dose PPI therapy for NERD patients. Thus, we hypothesize that a double dose PPI would accelerate and sustain the control of symptom in NERD patients.
In Asian, the majority of GERD cases are cases of nonerosive reflux esophagitis(NERD). NERD is a difficult -to-treat acid reflux condition even with PPI compared to reflux esophagitis(RE). In addition, the quality of life of NERD patients is quite low, NERD patients need quicker and more effective treatment options. At present, PPI-based step-down treatment is recommended for GERD patients. Doubling th PPI dose has become a commonly practiced therapeutic strategy in patients with GERD who failed PPI once daily. In patients with symptomatic GERD who failed the one dose PPI can increase the rate of overall symptom improvement by 22-26%. There are various mechanisms for standard dose PPI failure in GERD patients. Esophageal hypersensitivity is likely the underlying mechanism in a significant number of patients. Patients with the sensitive esophagus (normal endoscopy and pH test but positive symptom index) were more likely to respond to PPI twice a day. It is thus of clinical interest to determine whether an increased dosage of PPI can achieve rapidly the control of symptoms for patient with NERD patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Double dose rabeprazole | Active Comparator | Rabeprazole 20m bid per day will be given for 2 weeks |
|
| standard dose rabeprazole | Placebo Comparator | rabeprazole 20mg per day will bi given for 2 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rabeprazole | Drug | rabeprazole 20mg bid per day for 2 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| symptom improvement at 2 week after double dose rabeprazole treatment | symptom improvement according to FSSG(the frequency scale for the symptoms of GERD) at 2 week after double dose rabeprazole treatment | Two weeks |
| Measure | Description | Time Frame |
|---|---|---|
| sustained symptom improvement at 6 week after treatment | sustained symptom improvement assessed by FSSG(the frequency scale for the symptoms of GERD)score at 6 week after treatment | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tae Oh Kim, M.D. PhD. | Internal Medicine, Haeundae Paik Hospital | Study Director |
| Eun Hee Seo, M.D | Internal Medicine, Haeundae Paik Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haeundae Paik Hospital, Inje University School of Medicine | Busan | 612-030 | South Korea |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D064750 | Rabeprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| standard dose rabeprazole |
| Drug |
rabeprazole 20mg qd per day for 2 weeks |
|
| D004066 | Digestive System Diseases |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |