The Study to Evaluate Efficacy and Safety of Newrabell® Tab.(Rabeprazole Sodium) 10mg b.i.d in Refractory GERD

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the efficacy and safety of Newrabell® Tab. in patients with refractory reflux esophagitis to the prior standard PPIs regimen.

Official Title
-----------------
An 8-weeks, Multicenter, Single Arm, Non-comparative, Phase 4 Clinical Trial to Assess the Efficacy and Safety of Newrabell® Tab. at 10mg b.i.d in Patients With Refractory Reflux Esophagitis(rGERD) to the Prior Standard PPIs Regimen

Conditions
-----------------
Reflux Esophagitis

Intervention / Treatment
-----------------
* Drug: Newrabell® Tablet 10mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Female aged ≥ 20 years Reflux esophagitis with erosion or ulceration confirmed by endoscopic exam. Refractory reflux esophagitis to PPIs standard treatment as follows Ongoing heartburn symptom with or without these GERD-related symptoms : Regurgitation, Non-cardiac chest pain, Epigastric pain, Belching, Bloating, Satiety, Sore throat, Cough, Laryngitis, Hoarseness, Nausea, Vomiting, Dysphagia, Odynophagia, Weight loss Ongoing heartburn symptom with or without erosion ≥ grade A according to LA Classification Ongoing heartburn symptoms ≥ 2 days during 1week right before administering first dose of IP Decided to participate and signed on an informed consent form willingly Exclusion Criteria: Existence of upper gastrointestinal bleeding or active gastroduodenal ulcer at screening History of operation in esophagus, stomach or duodenum The following medical history Primary esophageal motility disease, Achalasia, Scleroderma, Esophageal/pyloric stricture, Primary esophageal spasm Barrett's esophagus ≥ 3 cm Zollinger-Ellison syndrome Infectious or inflammatory bowel disease, Severe malabsorption Severe chronic heart failure, cardiovascular disease, renal failure, COPD, asthma, liver cirrhosis History of cancer within 5 years, except completely recovered skin cancer ALT or AST ≥ Upper limit of normal range X 3 Need antibiotics due to severe infection Severe medical disease that needs these prohibited medication Anticoagulant(Heparin, Warfarin, etc.), High dose of aspirin(>325mg/d), Digitalis(Digoxin, etc.), Diuretics, Atazanavir, NSAIDs or Steroids Use PPIs or H2RA medicine within 1 week before administering first dose of IP, or need other PPIs or H2RA medicine during trial period Allergy or hypersensitivity to IP or similar chemical structure(Benzimidazol derivatives, etc.) Pregnant or breast-feeding women Conversation impairment because of alcohol, drug addiction or mental illness, etc. Administration of other IP within 28 days Inability to record heartburn diary card In investigator's judgement

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Newrabell single arm<br>Newrabell® Tablet 10mg b.i.d PO during 8 weeks | Drug: Newrabell® Tablet 10mg<br> <br> * Other names: Rabeprazole sodium;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to onset of first 1Day Heartburn free, Days |  | up to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to onset of first 2Days Heartburn free, Days |  | up to 8 weeks | 
| 1Day Heartburn free days, % |  | up to 8 weeks | 
| Time in Daytime of first Heartburn free, Days |  | up to 8 weeks | 
| Time in Nighttime of first Heartburn free, Days |  | up to 8 weeks | 
| Weekly Heartburn Improvement Rate, % |  | up to 8 weeks | 
| Average Daytime and Nighttime Heartburn Score Change at W4 |  | up to 8 weeks | 
| Average Daytime and Nighttime Heartburn Score Change at W8 |  | up to 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Refractory Reflux Esophagitis, GERD, Phase 4