Status:
COMPLETED
The Study to Evaluate Efficacy and Safety of Newrabell® Tab.(Rabeprazole Sodium) 10mg b.i.d in Refractory GERD
Lead Sponsor:
Chong Kun Dang Pharmaceutical
Conditions:
Reflux Esophagitis
Eligibility:
All Genders
20+ years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT01860482
Start Date
April 1 2013
End Date
May 1 2015
Last Update
September 24 2015
Active Locations (2)
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1
Chonnam National University Hospital
Gwangju, Donggu, Jebongro, South Korea, 501-757
2
Chonnam National University Hwasun Hospital
Gwangju, Hwasun-eup,Hwasun-gun, South Korea, 519-763