Clinical Trial to Assess the Efficacy and Safety of YYD601 in the Treatment of Esophageal Reflux Disease (ERD)

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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A Randomized, Double-blind, Double-dummy, Active Comparator, Multi-centers, Non-inferiority Design Clinical Trial to Assess the Efficacy and Safety of YYD601 in the Treatment of Esophageal Reflux Disease (ERD) (Phase3).

Conditions
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Erosive Esophagitis

Intervention / Treatment
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* Drug: YYD601 40mg
* Drug: Nexium 40mg
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A man or woman over 20 years old less than 70 years old. A man or woman who has experienced symptom (heartburn and acid regurgitation) within 7 days before Visit 1, meet below 1) or 2) criteria, who has been made diagnosis as Erosive esophagitis(LA grade A D) measured through the endoscopy which is carried out within (-2W±D2) * Symptom (heartburn and acid regurgitation) is confirmed by RDQ. Experienced above 2 days in 1 week, Heartburn of acid regurgitation above the weakness. Experienced above 1 day in 1 week, Heartburn of acid regurgitation above the middle. A man or woman who has a full understanding of this clinical trial through the detailed explanation, agree in writing to participate in this trial. Exclusion Criteria: Who has hyper sensitivity reaction about other drugs, ingredients, components of investigator product or compound of benzimidazole. Who has NERD Who get a diagnosis as a IBS within the last 3 months. Who have taken gastric acid secretion inhibitors including PPIs within 2 weeks before the endoscopy. Who have taken drugs about reflux esophagitis (H₂-receptor inhibitor (H2RA) Prostaglandin(PG), Antacid, Prokinetic acid etc.) above 2 times as an usual dose. (* refer to the Concomitant medication in text.) Who has been experienced the disease affecting the esophagus(Eosinophilic esophagitis, esophageal varices, cirrhosis, Virus or Fungal infection, Esophageal stricture, primary esophageal motility disorder and gastrointestinal bleeding). Or who has a history of radio therapeutics, freeze treatment about the esophagus. Who has clinically significant abnormal result of ECG. Abnormal result of Major arrhythmia, Multifocal PVS, 2 AV-blcok etc. Who has the Schatzki near the LES(lower esophageal sphincter) except the Barret's esophagus.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: YYD601 40mg<br>Esomeprazole magnesium Dihydrate. | Drug: YYD601 40mg<br>* Patients should take druges 30 minutes before breakfast.<br>Drug: Placebos<br>* 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.<br>|
| Active Comparator: Nexium 40mg<br>Esomeprazole magnesium trihydrate, a substituted benzimidazole. | Drug: Nexium 40mg<br>* Patients should take druges 30 minutes before breakfast.<br>Drug: Placebos<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | within 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | at week 4 and 8 from baseline |