Reflux Esophagitis
Conditions
Keywords
Refractory Reflux Esophagitis, GERD, Phase 4
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.
Interventions
DRUGNewrabell® Tablet 10mg
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or Female aged ≥ 20 years 2. Reflux esophagitis with erosion or ulceration confirmed by endoscopic exam. 3. 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 4. Ongoing heartburn symptoms ≥ 2 days during 1week right before administering first dose of IP 5. Decided to participate and signed on an informed consent form willingly
Exclusion criteria
1. Existence of upper gastrointestinal bleeding or active gastroduodenal ulcer at screening 2. History of operation in esophagus, stomach or duodenum 3. 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 4. Severe chronic heart failure, cardiovascular disease, renal failure, COPD, asthma, liver cirrhosis 5. History of cancer within 5 years, except completely recovered skin cancer 6. ALT or AST ≥ Upper limit of normal range X 3 7. Need antibiotics due to severe infection 8. 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 9. Use PPIs or H2RA medicine within 1 week before administering first dose of IP, or need other PPIs or H2RA medicine during trial period 10. Allergy or hypersensitivity to IP or similar chemical structure(Benzimidazol derivatives, etc.) 11. Pregnant or breast-feeding women 12. Conversation impairment because of alcohol, drug addiction or mental illness, etc. 13. Administration of other IP within 28 days 14. Inability to record heartburn diary card 15. In investigator's judgement
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to onset of first 1Day Heartburn free, Days | up to 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Time to onset of first 2Days Heartburn free, Days | 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 |
| Weekly Heartburn Improvement Rate, % | up to 8 weeks |
Countries
South Korea
Outcome results
None listed