Rate of Complete Symptom Relief, Prevention of Symptom Relapse: Grades A and B Esophagitis of Esomeprazole Therapy

Study Overview
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Brief Summary
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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

Detailed Description
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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 Rate of complete symptom relief (CSR) at the end of initial treatment phase rate of symptom relapse within 12 weeks after stopping initial therapy

Official Title
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The Rates of Complete Symptom Relief,Prevetion of Symptom Relapse and Maintenance of Esophagitis Healing for 4-week Versus 8-week Esomeprazole Therapy Among Los Angeles Grades A and B Erosive Esophagitis

Conditions
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Erosive Esophagitis

Intervention / Treatment
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* Drug: Esomeprazole 40 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: coexistence of peptic ulcer or gastrointestinal malignancies, pregnancy, coexistence of serious concomitant illness (for example, decompensated liver cirrhosis and uremia), previous gastric surgery, allergy to esomeprazole, symptom score of a validated questionnaire (Chinese GERDQ) less than 12, and equivocal endoscopic diagnosis of Los Angeles Grade A and B erosive esophagitis.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: GERD Los Angeles A and B-4 week group<br>Patients with Los Angeles A and B esophagitis prescribed with esomeprazole (40 mg)daily- 4 week group | Drug: Esomeprazole 40 mg<br>* 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<br>* Other names: Nexium 40mg;|
| Active Comparator: GERD Los Angeles A and B-8-week group<br>Patients with Los Angeles A and B esophagitis prescribed with esomeprazole (40 mg)daily- 8 week group | Drug: Esomeprazole 40 mg<br>* 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<br>* Other names: Nexium 40mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. |