A randomized, double-blind, double-dummy, active comparator, multi-centers, non-inferiority design clinical trial to assess the efficacy and safety of YYD601 in ERD patients (phase 3).
This phase 3 clinical trial is designed as randomized, active-comparator, double-dummy, multi-center for ERD patients, who take YYD601 40mg or Nexium 40mg for 8 weeks. Each part is assessed by 'LA grade' measured through the endoscopy, target goal is to confirm the non-inferiority of YYD601 40mg to Nexium 40mg.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
170
Patients should take druges 30 minutes before breakfast.
Patients should take druges 30 minutes 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
LA grade 0(zero)
Percentage of patients(%) who's erosive esophagitis has been recovered to LA grade 0(zero) within week 8. Calculation of the sample size was based on a margin of non-inferiority by Normal approximation.
Time frame: within 8 weeks
LA grade 0(zero)
Percentage of patients(%) who's erosive esophagitis has been recovered to LA grade 0(zero) by Normal approximation and Fisher's exact test.
Time frame: at 4 weeks
Frequency variation of the Heartburn and acid regurgitation by RDQ(questionnaire).
Change in frequency of the symptom(heartburn and acid regurgitation) by Shapiro-Wilk test and Wilcoxon's rank sum test.
Time frame: at week 4 and 8 from baseline
Frequency variation of the Heartburn in daytime by patients diary
Percentage of patients(%) who have the symptom(heartburn and acid regurgitation) by Chi-square test and Fisher's exact test.
Time frame: at 4 week and 8 week from baseline
Frequency variation of the Heartburn in nighttime by patients diary
Percentage of patients(%) who have the symptom(heartburn and acid regurgitation) by Chi-square test and Fisher's exact test.
Time frame: at 4 week and 8 week from baseline
Days percentage(%) of no symptoms about the Heartburn and acid regurgitation
Patients who have experienced the heartburn and acid regurgitation in nighttime by patients diary.
Time frame: at week 4 and 8 from baseline
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.