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

Primary Purpose

Reflux Esophagitis

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Newrabell® Tablet 10mg

About this trial

This is an interventional treatment trial for Reflux Esophagitis focused on measuring Refractory Reflux Esophagitis, GERD, Phase 4

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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
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
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 Criteria:

Existence of upper gastrointestinal bleeding or active gastroduodenal ulcer at screening
History of operation in esophagus, stomach or duodenum
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
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

Sites / Locations

Chonnam National University Hospital
Chonnam National University Hwasun Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Newrabell single arm

Arm Description

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

Outcomes

Primary Outcome Measures

Time to onset of first 1Day Heartburn free, Days

Secondary Outcome Measures

Time to onset of first 2Days Heartburn free, Days

1Day Heartburn free days, %

Time in Daytime of first Heartburn free, Days

Time in Nighttime of first Heartburn free, Days

Weekly Heartburn Improvement Rate, %

Average Daytime and Nighttime Heartburn Score Change at W4

Average Daytime and Nighttime Heartburn Score Change at W8

Full Information

NCT ID

NCT01860482

First Posted

May 20, 2013

Last Updated

September 22, 2015

Sponsor

Chong Kun Dang Pharmaceutical

1. Study Identification

Unique Protocol Identification Number

NCT01860482

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2015

Overall Recruitment Status

Completed

Study Start Date

April 2013 (undefined)

Primary Completion Date

May 2015 (Actual)

Study Completion Date

May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Chong Kun Dang Pharmaceutical

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Reflux Esophagitis

Keywords

Refractory Reflux Esophagitis, GERD, Phase 4

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

39 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Newrabell single arm

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Newrabell® Tablet 10mg

Other Intervention Name(s)

Rabeprazole sodium

Primary Outcome Measure Information:

Title

Time to onset of first 1Day Heartburn free, Days

Time Frame

up to 8 weeks

Secondary Outcome Measure Information:

Title

Time to onset of first 2Days Heartburn free, Days

Time Frame

up to 8 weeks

Title

1Day Heartburn free days, %

Time Frame

up to 8 weeks

Title

Time in Daytime of first Heartburn free, Days

Time Frame

up to 8 weeks

Title

Time in Nighttime of first Heartburn free, Days

Time Frame

up to 8 weeks

Title

Weekly Heartburn Improvement Rate, %

Time Frame

up to 8 weeks

Title

Average Daytime and Nighttime Heartburn Score Change at W4

Time Frame

up to 8 weeks

Title

Average Daytime and Nighttime Heartburn Score Change at W8

Time Frame

up to 8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jongsun Rew, Ph.D

Organizational Affiliation

Chonnam National University Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Sungbum Cho, Ph.D

Organizational Affiliation

Chonnam National University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Chonnam National University Hospital

City

Gwangju

State/Province

Donggu, Jebongro

ZIP/Postal Code

501-757

Country

Korea, Republic of

Facility Name

Chonnam National University Hwasun Hospital

City

Gwangju

State/Province

Hwasun-eup,Hwasun-gun

ZIP/Postal Code

519-763

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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