Conditions: Erosive Esophagitis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 408
Healthy volunteers: no

Brief summary:
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:
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

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

Arms:
arm 1: Patients with Los Angeles A and B esophagitis prescribed with esomeprazole (40 mg)daily- 4 week group arm 2: Patients with Los Angeles A and B esophagitis prescribed with esomeprazole (40 mg)daily- 8 week group

Interventions: intervention 1: Esomeprazole 40 mg
Intervention descriptions: intervention 1: 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

Protocol document: