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To investigate the impact of initial treatment duration (4-week versus 8-week)of Esomeprazole (40mg) on the rate of symptom relapse and sustained healing of esophagitis in patients with symptomatic erosive esophagitis
Patients:
Patients between the ages of 15 and 80 years with clinical symptoms of acid regurgitation, heart burn, or feeling of acidity in the stomach, who have Los Angeles Grade A and B erosive esophagitis proven by endoscopy are recruited. Criteria for exclusions include (1) coexistence of peptic ulcer or gastrointestinal malignancies, (2) pregnancy, (3) coexistence of serious concomitant illness (for example, decompensated liver cirrhosis and uremia), (4) previous gastric surgery, (5) allergy to esomeprazole, (6) symptom score of a validated questionnaire (Chinese GERDQ) less than 12, and (7) equivocal endoscopic diagnosis of Los Angeles Grade A and B erosive esophagitis.
Outcome parameters:
The main outcome measures
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GERD Los Angeles A and B-4 week group | Active Comparator | Patients with Los Angeles A and B esophagitis prescribed with esomeprazole (40 mg)daily- 4 week group |
|
| GERD Los Angeles A and B-8-week group | Active Comparator | Patients with Los Angeles A and B esophagitis prescribed with esomeprazole (40 mg)daily- 8 week group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esomeprazole 40 mg | Drug | Comparison of 4-weeks and 8-weeks initial treatment duration of esomeprazole 40 mg per day on the rate of symptom relapse and sustained healing of esophagitis in patients with symptomatic erosive esophagitis |
| Measure | Description | Time Frame |
|---|---|---|
| The Rates of Complete Symptom Relief | Rate of complete symptom relief (CSR) at the end of initial treatment phase | at the 20 weeks after the end of initial treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seng-Kee Chuah, M.D | Kaohsiung Chang Gung Memorial Hospital,Taiwan | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seng-Kee Chuah | Kaohsiung City | 833 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25245625 | Derived | Hsu PI, Lu CL, Wu DC, Kuo CH, Kao SS, Chang CC, Tai WC, Lai KH, Chen WC, Wang HM, Cheng JS, Tsai TJ, Chuah SK. Eight weeks of esomeprazole therapy reduces symptom relapse, compared with 4 weeks, in patients with Los Angeles grade A or B erosive esophagitis. Clin Gastroenterol Hepatol. 2015 May;13(5):859-66.e1. doi: 10.1016/j.cgh.2014.09.033. Epub 2014 Sep 20. |
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The data will be shared in July 2017
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| ID | Title | Description |
|---|---|---|
| FG000 | 4-week Group | Patients with Los Angeles A and B esophagitis prescribed with esomeprazole (40 mg)daily Esomeprazole 40 mg: Comparison of 4-weeks initial treatment duration of esomeprazole 40 mg per day on the rate of symptom relapse and sustained healing of esophagitis in patients with symptomatic erosive esophagitis |
| FG001 | 8-week Group | Patients with Los Angeles A and B esophagitis prescribed with esomeprazole (40 mg)daily Esomeprazole 40 mg: Comparison of 8-weeks initial treatment duration of esomeprazole 40 mg per day on the rate of symptom relapse and sustained healing of esophagitis in patients with symptomatic erosive esophagitis |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline characteristics of the enrolled patients
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| ID | Title | Description |
|---|---|---|
| BG000 | 4-week Group | Patients with Los Angeles A and B esophagitis prescribed with esomeprazole (40 mg)daily Esomeprazole 40 mg: Comparison of 4-weeks initial treatment duration of esomeprazole 40 mg per day on the rate of symptom relapse and sustained healing of esophagitis in patients with symptomatic erosive esophagitis |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Rates of Complete Symptom Relief | Rate of complete symptom relief (CSR) at the end of initial treatment phase | Posted | Number | participants | at the 20 weeks after the end of initial treatment. |
|
20 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 4 Week Group | Patients with Los Angeles A and B esophagitis prescribed with esomeprazole (40 mg)daily Esomeprazole 40 mg: Comparison of 4-weeks initial treatment duration of esomeprazole 40 mg per day on the rate of symptom relapse and sustained healing of esophagitis in patients with symptomatic erosive esophagitis |
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The trial was performed in a single country
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Seng-Kee Chuah and Dr. Wei-Chen Tai | Kaohsiung Chang Gung Memorial Hospital, Taiwan | 886-975056007 | chuahsk@seed.net.tw |
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| ID | Term |
|---|---|
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
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|
| 8-week Group |
Patients with Los Angeles A and B esophagitis prescribed with esomeprazole (40 mg)daily Esomeprazole 40 mg: Comparison of 8-weeks initial treatment duration of esomeprazole 40 mg per day on the rate of symptom relapse and sustained healing of esophagitis in patients with symptomatic erosive esophagitis |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
|
| 0 |
| 207 |
| 0 |
| 207 |
| 0 |
| 207 |
| EG001 | 8 Week Group | Patients with Los Angeles A and B esophagitis prescribed with esomeprazole (40 mg)daily Esomeprazole 40 mg: Comparison of 8-weeks initial treatment duration of esomeprazole 40 mg per day on the rate of symptom relapse and sustained healing of esophagitis in patients with symptomatic erosive esophagitis | 0 | 201 | 0 | 201 | 0 | 201 |
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| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |