Safety to Evaluate the Efficacy and Safety of HIP1601 in Patients With Non Erosive Reflux Disease

Study Overview
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Brief Summary
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The purpose of this study is to investigate the safety and clinical efficacy of HIP1601 in patients with Non-erosive gastroesphageal reflux disease.

Detailed Description
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A Multicenter, Randomized, Parallel, Double-Blinded, Placebo-controlled Phase Ⅲ Study to Compare Efficacy and Safety of HIP1601 in Patients with Non-Erosive Gastroesophageal Reflux Disease(NERD)

Official Title
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A Multicenter, Randomized, Parallel, Double-Blinded, Placebo-controlled Phase 3 Study to Compare Efficacy and Safety of HIP1601 in Patients With Non-Erosive Gastroesophageal Reflux Disease(NERD)

Conditions
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Non-erosive Gastroesphageal Reflux Disease

Intervention / Treatment
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* Drug: HIP1601
* Drug: HGP1805


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 19≤ age ≤ 75 Patients who were not observed mucosal break('not present') according to the LA classification(LA grade) on the EGDEsophago-Gastro-Duodenoscopy Patients who had experienced major symptom within 3 months Patients experienced heartburn or acid regurgitation within 7 days of screening day Patients who had experienced major symptom within 7 days before randomization. Entry into study also required that patients had experienced at least mild symptoms on at least 2 days/week or at least moderate symptoms on at least 1 day/week based on RDQ Patients understood the consents and purpose of this trial and signed consent form Exclusion Criteria: Patients who have erosive GERD, Barrett's esophagus(other significant dysplasia of esophagus), gastroesophageal varicose veins, active peptic ulcer, gastrointestinal bleeding or malignant GI tumor confirmed by endoscopy Patients who have a history of gastric or gastroesophageal surgery Patients who have Zollinger-Ellison syndrome, eosinophilic esophagitis, primary esophageal motility disorder, acute upper gastrointestinal bleeding, Functional dyspepsia, IBS, IBD within 3 months before Visit 1 Patients with clinically significant liver, kidney, nervous system, respiratory, endocrine, hematologic, cardiovascular, urinary system disease. Patients Has a severe liver disorder(AST or ALT level exceeds 3 times more than normal upper range at Visit 1) Has a clinically significant renal failure(MDRD eGFR ≤ 59 mL/min/1.73m2 or Serum creatinine >2.0mg/dL at Visit 1)

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 75 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HIP1601 Amg<br>The participants will receive tretment of HIP1601 Amg, orally, once daily for 4weeks. | Drug: HIP1601<br>* HIP1601<br>|
| Placebo Comparator: HGP1805<br>The participants will receive tretment of HGP1805(Placebo of HIP1601), orally, once daily for 4weeks. | Drug: HGP1805<br>* Placebo of HIP1601<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with complete resolution of major symptoms at 4-week | Complete resolution is defined as no episodes of symptom during the last 7 days of treatment. | 4 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with complete resolution of major symptoms at 2-week | Complete resolution is defined as no episodes of symptom during the last 7 days of treatment | 2 week | 
| Frequency and Severity of Reflux disease symptom assessment using Reflux Disease Questionnaire(RDQ) | RDQ frequncy and severity score is 0 to 5 point scale, high score mean a worse outcome. | 2, 4 week | 
| Time to complete resolution of major symptoms | defined as time to the first day of complete resolution | 4 week | 
| Resolution rate of major symptoms of first 7 days | defined as first of 7 days with no episodes of symptom using subject's diary | 1 week | 
| Major symptoms-Free days | Major symptoms-Free days mean rate of days that symtom's severity score is '0' using subject's diary | 1, 4 week | 
| Quality of Life assessment using Patient Assessment of upper Gastrointestinal disorders-Quality of Life(PAGI-QoL) | PAGI-QoL total score is 0 to 30 point scale, high score mean a better outcome. | 4 week | 
| Proportion of rescue medication amounts | Use of rescue medication | 4 week |