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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2015-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Reflux Esophagitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Newrabell single arm

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

Group Type EXPERIMENTAL

Newrabell® Tablet 10mg

Intervention Type DRUG

Interventions

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Newrabell® Tablet 10mg

Intervention Type DRUG

Other Intervention Names

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Rabeprazole sodium

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No