To Evaluate the Efficacy and Safety of EsoDuo Tab. 20/800mg
A multicenter, randomized, double-blind, active-controlled phase 4 study to evaluate the efficacy and safety of EsoDuo Tab. 20/800mg in patients with non-erosive reflux disease(NERD)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
379
Nexium Tab. 20mg
Complete resolution of heartburn(HB), Last 7 days of treatment, 4 weeks.
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Time frame: 4 weeks after drug administrations.
Complete resolution of heartburn(HB), Last 7 days of treatment, 2 weeks.
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Time frame: 2 weeks after drug administrations
Complete resolution of Acid regurgitation, Last 7 days of treatment, 2 / 4 weeks.
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Time frame: 2/4 weeks after drug administrations.
The percentage of Heartburn(HB) / Acid regurgitation only 1 day or less free days, 2 / 4 weeks.
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Time frame: 2/4 weeks after drug administrations.
The percentage of free days without Heartburn(HB) / Acid regurgitation, 2 / 4 weeks.
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Time frame: 2/4 weeks after drug administrations.
The time to the first 24/48-h, 7-d of Heartburn(HB) / Acid regurgitation free interval.
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Time frame: 2/4 weeks after drug administrations.
Change from baseline in the Heartburn(HB) / Acid regurgitation Symptom score, 2 / 4 weeks.
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Time frame: 2/4 weeks after drug administrations.
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Dong-A University Hospital
Busan, South Korea
Kosin University Gospel Hospital
Busan, South Korea
Soonchunhyang University Cheonan Hospital
Cheonan, South Korea
Chungbuk National University Hospital
Cheongju-si, South Korea
Hallym University Chuncheon Seonsim Hospital
Chuncheon, South Korea
Daegu Catholic Hospital
Daegu, South Korea
Keimyung University Dongsan Medical Center
Daegu, South Korea
Yeungnam University Medicar Center
Daegu, South Korea
Chungnam National University Hospital
Daejeon, South Korea
Myongji Hospital
Goyang, South Korea
...and 28 more locations
Heartburn(HB) / Acid regurgitation symptoms per investigator assessment, 4weeks.
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Time frame: 4 weeks after drug administrations.
Time to first resolution of Heartburn(HB), Day 1
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Time frame: 1 day after drug administrations.