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

An 8-weeks, Multicenter, Single Arm, Non-comparative, Phase 4 Clinical Trial to Assess the Efficacy and Safety of Newrabell® Tab. at 10mg b.i.d in Patients With Refractory Reflux Esophagitis(rGERD) to the Prior Standard PPIs Regimen

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.

Study Overview

• Status: Completed
• Conditions: Reflux Esophagitis
• Intervention / Treatment: Drug: Newrabell® Tablet 10mg

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Donggu, Jebongro
    • Gwangju, Donggu, Jebongro, Korea, Republic of, 501-757
      • Chonnam National University Hospital
  • Hwasun-eup,Hwasun-gun
    • Gwangju, Hwasun-eup,Hwasun-gun, Korea, Republic of, 519-763
      • Chonnam National University Hwasun Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Newrabell single arm; Newrabell® Tablet 10mg b.i.d PO during 8 weeks	Drug: Newrabell® Tablet 10mg; Other Names: Rabeprazole sodium

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to onset of first 1Day Heartburn free, Days	up to 8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to onset of first 2Days Heartburn free, Days	up to 8 weeks
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
Weekly Heartburn Improvement Rate, %	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

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Investigators: Principal Investigator: Jongsun Rew, Ph.D, Chonnam National University Hospital; Principal Investigator: Sungbum Cho, Ph.D, Chonnam National University Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: May 20, 2013
• First Submitted That Met QC Criteria: May 21, 2013
• First Posted (Estimate): May 22, 2013

Study Record Updates

• Last Update Posted (Estimate): September 24, 2015
• Last Update Submitted That Met QC Criteria: September 22, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: GERD; Phase 4; Refractory Reflux Esophagitis
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Intestinal Diseases; Esophageal Diseases; Peptic Ulcer; Duodenal Diseases; Esophagitis, Peptic; Esophagitis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Rabeprazole
• Other Study ID Numbers: 243GERD13003