Erosive Esophagitis Clinical Trial
Official title:
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
NCT number | NCT01874535 |
Other study ID # | GERD A and B |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | June 2010 |
Est. completion date | June 2016 |
Verified date | June 2017 |
Source | Chang Gung Memorial Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 408 |
Est. completion date | June 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 15 Years to 80 Years |
Eligibility |
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: 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. |
Country | Name | City | State |
---|---|---|---|
Taiwan | Seng-Kee Chuah | Kaohsiung |
Lead Sponsor | Collaborator |
---|---|
Chang Gung Memorial Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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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