Clinical Trial to Assess the Efficacy and Safety of YYD601 in NERD Patients

Study Overview
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Brief Summary
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Clinical Trial to Assess the Efficacy and Safety of YYD601 in NERD Patients

Detailed Description
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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).

Official Title
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A Randomized, Double-blind, Placebo-controlled, Multi-centers Clinical Trial to Assess the Efficacy and Safety of YYD601 in NERD Patients (Phase3).

Conditions
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Non-erosive Reflux Disease

Intervention / Treatment
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* Drug: YYD601 20mg
* Drug: Nexium 20mg
* 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 below all characters and diagnosis as NERD. A man or woman who has experienced symptom(hearburn or/and acid regurgitation) over 3month at least. A man or woman who has experienced symptom(heartburn or/and acid regurgitation) within 7days before Visit1, meet below 1) or 2) criteria. ** Symptom (heartburn and acid regurgitation) is confirmed by RDQ Experienced above 2 days in a week, heartburn of acid regurgitation above the weakness. Experienced above 1 day in a week, heartburn of acid regurgitation above the middle. A man or woman who has been made diagnosis as LA grade0(Zero) measured through the dendoscopy which is corried out within 14 days, there is no observed muscosal break. 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 ERD. Who get a diagnosis as a IBS within the last 3 months. 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 havbe taken gastric acid secretion inhibitors including PPIs within 2 weeks before the endoscopy. 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 the gastric or duodenal ulcer, Zollinger-Ellison and other acid hypersecretory condition been experienced. Who has hyper-sensitivity, reaction about PPIs (ex. Lansoprazole, omeprazole, rabeprazole, pantoprazole or esomeprazole). Who has gotten a diagnosis as a cancer within 5 years before participated in this clinical trail (expect the basal cell on the skin), peptic ulcer or benign tumor.

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 20mg<br>Esomeprazole magnesium Dihydrate. | Drug: YYD601 20mg<br>* Patients should take drugs an hour 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 20mg<br>Esomeprazole magnesium trihydrate, a substituted benzimidazole. | Drug: Nexium 20mg<br>* Patients should take drugs an hour 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 |
| --- | --- | --- |
| Recovered percentage(%) of the symptom | Recovered percentage(%) of the symptom(heartburn or/and acid regurgitation) measured by RDQ after administration(baseline). | 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). | 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). | 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). | 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). | within 4 weeks |