Clinical Trial to Assess the Efficacy and Safety of YYD601 in NERD Patients
This Phase 3 Clinical Trial is Designed as Randomized, Double-blind, Placebo-controlled, Multi-centers Clinical Trial to Assess the Efficacy and Safety of YYD601 in NERD Patients (Phase3).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
170
Patients should take drugs an hour before breakfast.
Patients should take drugs an hour before breakfast.
The placebo YYD601 is made from microcrystalline cellulose covered with hard shell. The placebo Nexium is made from microcrystalline cellulose, Crospovidone, Magnesiumstearat and other ingredients.
Korea University Ansan Hospital
Seoul, South Korea
Recovered percentage(%) of the symptom
Recovered percentage(%) of the symptom(heartburn or/and acid regurgitation) measured by RDQ after administration(baseline).
Time frame: within 4 weeks
Change of the score about the symptom
Change of the score about the symptom(heartburn or/and acid regurgitation) measured by RDQ after administration(baseline).
Time frame: within 4 weeks
Percentage(%) of the patients who have symptom during the daytime
Percentage(%) of the patients who have symptom(heartburn or/and acid regurgitation) during the daytime measured by Patients diary after administration(baseline).
Time frame: within 4 weeks
Percentage(%) of the patients who have symptom during the nighttime
Percentage(%) of the patients who have symptom(heartburn or/and acid regurgitation) during the nighttime measured by Patients diary after administration(baseline).
Time frame: within 4 weeks
Percentage(%) of the days no symtom
Percentage(%) of the days no symptom(heartburn or/and acid regurgitation) among the patients who have symptom(heartburn or/and acid regurgitation) during the nighttime measured by Patients diary after administration(baseline).
Time frame: within 4 weeks
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