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

Erosive Esophagitis research study

What is the primary objective of this study?

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

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Erosive Esophagitis

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Esomeprazole 40 mgComparison 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

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

GERD Los Angeles A and B-4 week groupPatients with Los Angeles A and B esophagitis prescribed with esomeprazole (40 mg)daily- 4 week group

GERD Los Angeles A and B-8-week groupPatients with Los Angeles A and B esophagitis prescribed with esomeprazole (40 mg)daily- 8 week group

Study Status

Completed

Start Date: June 2010

Completed Date: June 2016

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: The Rates of Complete Symptom Relief

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Seng-Kee Chuah, M.D

Lead Sponsor: Chang Gung Memorial Hospital

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01874535

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