Reflux Esophagitis | The Study to Evaluate Efficacy and Safety of Newrabell® Tab.(Rabeprazole Sodium) 10mg b.i.d in Refractory GERD
Reflux Esophagitis research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Newrabell® Tablet 10mg
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Newrabell single armNewrabell® Tablet 10mg b.i.d PO during 8 weeks
Start Date: April 2013
Completed Date: May 2015
Phase: Phase 4
Primary Outcome: Time to onset of first 1Day Heartburn free, Days
Secondary Outcome: Time to onset of first 2Days Heartburn free, Days
Study sponsors, principal investigator, and references
Principal Investigator: Jongsun Rew, Ph.D
Lead Sponsor: Chong Kun Dang Pharmaceutical