NCT01874535

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 408 (actual)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: 15 Years – 80 Years
• Healthy volunteers: Not accepted

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

Conditions

• Erosive Esophagitis

Interventions

Type	Name	Description
DRUG	Esomeprazole 40 mg	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

Timeline

• Start date: 2010-06-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2013-06-11
• Last updated: 2018-09-04
• Results posted: 2018-09-04

Locations

1 site across 1 country: Taiwan