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

Recruitment & Eligibility

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
1. 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
2. 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
1. Primary esophageal motility disease, Achalasia, Scleroderma, Esophageal/pyloric stricture, Primary esophageal spasm
2. Barrett's esophagus ≥ 3 cm
3. Zollinger-Ellison syndrome
4. 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

Study & Design

Arm && Interventions

Group	Intervention	Description
Newrabell single arm	Newrabell® Tablet 10mg	Newrabell® Tablet 10mg b.i.d PO during 8 weeks

Primary Outcome Measures

Name	Time	Method
Time to onset of first 1Day Heartburn free, Days	up to 8 weeks

Secondary Outcome Measures

Name	Time	Method
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
Time to onset of first 2Days Heartburn free, Days	up to 8 weeks

Recruitment & Eligibility