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

Chong Kun Dang

Status and phase: Completed; Phase 4

Conditions: Reflux Esophagitis

Treatments: Drug: Newrabell® Tablet 10mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01860482

243GERD13003

Details and patient eligibility

About

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.

Enrollment: 39 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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39 participants in 1 patient group

Newrabell single arm

Experimental group

Description:

Newrabell® Tablet 10mg b.i.d PO during 8 weeks

Treatment:

Drug: Newrabell® Tablet 10mg