Efficacy and Safety of HIP1601 Capsule

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

Official Title
-----------------
A Multicenter, Randomized, Double-blind, Phase Ⅲ Study to Compare Efficacy and Safety of HIP1601 40mg and HGP1705 40mg in Patients With Erosive Gastroesophageal Reflux Disease

Conditions
-----------------
Erosive Gastroesophageal Reflux Disease

Intervention / Treatment
-----------------
* Drug: HIP1601
* Drug: HGP1705
* Drug: HIP1601 Placebo
* Drug: HGP1705 Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 19≤ age ≤ 75 Esophago-Gastro-Duodenoscopy LA classification ≥ grade A Patients experienced heartburn or acid regurgitation within 7 days of screening day Patients understood the consents and purpose of this trial and signed consent form Exclusion Criteria: Has malignancy in the upper gastrointestinal tract, digestive ulcer, bleeding disorder or signs of gastrointestinal bleeding Has a severe liver disorder(at screening day, AST or ALT level exceeds 3 times more than normal upper range) Has a clinically significant renal failure(at screening day, MDRD eGFP ≤ 59 mL/min/1.73m2 or Serum creatinine >2.0mg/dL) Uncontrolled diabetes mellitus Before screening EGD, a patient who has taken H2-receptor antagonist or PPI within 2 weeks Before screening EGD, a patient who has taken drugs containing following list within 1 weeks : warfarin, anticholinergics for spasmolytic GI, antineoplastic agents, salicylates(except 100mg a day for prevention of cardiovascular disease), steroids, propulsives, sucralfate, NSAIDs, other antacids(e.g. antacids of prostaglandin analogs, antacids of aluminum/magnesium)

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: multicenter, randomized, double-blind, parallel group study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HIP1601+HGP1705 Placebo<br>HIP1601+HGP1705 Placebo for 4weeks. if not fully cured, take HIP1601+HGP1705 Placebo for addtional 4weeks | Drug: HIP1601<br>* Oral esomeprazole<br>* Other names: esomeprazole;Drug: HGP1705 Placebo<br>* Oral Placebo<br>|
| Experimental: HGP1705+HIP1601 Placebo<br>HGP1705+HIP1601 Placebo for 4weeks. if not fully cured, take HGP1705+HIP1601 Placebo for addtional 4weeks | Drug: HGP1705<br>* Oral Nexium Tab<br>* Other names: Nexium Tab;Drug: HIP1601 Placebo<br>* Oral Placebo<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete healing rate | percentage of subjects whose erosion is completely cured | at 4 weeks or 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete healing rate | percentage of subjects whose erosion is completely cured | at 4 weeks | 
| Complete resolution rate of each symptom in GERD |  | at 4,8 weeks | 
| Proportion of heartburn-free days, acid regurgitation-free days |  | at 1, 2, 4, 8 weeks | 
| Proportion of heartburn-free nights, acid regurgitation-free nights |  | at 1, 2, 4, 8 weeks | 
| Time to sustained resolution heartburn, acid regurgitation |  | at 4 weeks or 8 weeks | 
| Time to sustained resolution of nocturnal heartburn, nocturnal acid regurgitation |  | at 4 weeks or 8 weeks | 
| Total number of use of relief drugs and average usage per day |  | at 4 weeks or 8 weeks |