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Study to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Erosive Esophagitis

Primary Purpose

Erosive Esophagitis

Status

Completed

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

CJ-12420 100 mg QD

Esomeprazole 40 mg QD

About this trial

This is an interventional treatment trial for Erosive Esophagitis

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects aged between 20 and 70 years
Subjects who had experienced heartburn and regurgitation within 7 days before visit 1. Entry into study also required that patients had experienced at least mild upper gastrointestinal symptoms on at least 2 days/week or at least moderate upper gastrointestinal symptoms on at least 1 day/week
Endoscopically confirmed erosive esophagitis as defined by LA Classification Grading System (A-D) within 14 days prior to randomization
Subjects who is able to understand and follow the instructions and is willing to participate throughout the entire study
Subjects who voluntarily signed written informed consent form
Subjects who agreed to use medically acceptable contraceptives during the period of study.

Exclusion Criteria:

Subjects who cannot undergo EGD
Subjects who have esophageal stenosis, ulcer stenosis, gastroesophageal varices, Barrett's esophagus, active gastric ulcer, gastrointestinal bleeding or malignant tumor confirmed by EGD
Subjects who have warning symptoms of malignant gastrointestinal tract such as odynophagia, severe dysphagia, bleeding, weight loss, anemia, or bloody stool
Subjects with eosinophilic esophagitis
Subjects diagnosed with primary esophageal motility disorder, IBS, IBD, etc. or with suspected IBS in the last 3 months
Subjects who have a history of gastric acid suppression surgery or upper gastrointestinal, esophageal surgery
Pregnant or lactating women
Subjects with a history of clinically significant hepatic, renal, cardiovascular, respiratory, endocrine and CNS system disorder
Subjects with a history of hypersensitivity to the active ingredient or excipients of the study drug, etc.
Subjects who participated in the other clinical trial within 4 weeks prior to randomization

Sites / Locations

Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CJ-12420 100 mg QD

Esomeprazole 40 mg QD

Arm Description

CJ-12420 100 mg, tablet, once daily, oral administration for up to 8 weeks

Esomeprazole 40 mg, tablet, once daily, oral administration for up to 8 weeks

Outcomes

Primary Outcome Measures

Cumulative healing rate of erosive esophagitis at 8-week

Secondary Outcome Measures

Healing rate of erosive esophagitis at 4-week

Symptom assessment by subject diary and questionnaire

Full Information

NCT ID

NCT02456935

First Posted

May 27, 2015

Last Updated

December 14, 2016

Sponsor

HK inno.N Corporation

1. Study Identification

Unique Protocol Identification Number

NCT02456935

Brief Title

Study to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Erosive Esophagitis

Official Title

A Double-blind, Randomized, Active-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Erosive Esophagitis

Study Type

Interventional

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Completed

Study Start Date

May 2015 (undefined)

Primary Completion Date

July 2016 (Actual)

Study Completion Date

September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

HK inno.N Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to demonstrate the efficacy of CJ-12420, once daily (QD), compared to esomeprazole in patients with erosive esophagitis classified as Los Angeles (LA) classification grades A to D at Week 8

Detailed Description

This is a double blind, randomized, active controlled, phase 3 study. Subjects will be randomly assigned to one of the two treatment groups (CJ-12420 100 mg or esomeprazole 40 mg). All subjects will be asked to take two tablets at the same time each day throughout the study, and also all subjects will be asked to record daytime and nighttime symptom in a subject diary on a daily basis.

6. Conditions and Keywords

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

Erosive Esophagitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

280 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CJ-12420 100 mg QD

Arm Type

Experimental

Arm Description

CJ-12420 100 mg, tablet, once daily, oral administration for up to 8 weeks

Arm Title

Esomeprazole 40 mg QD

Arm Type

Active Comparator

Arm Description

Esomeprazole 40 mg, tablet, once daily, oral administration for up to 8 weeks

Intervention Type

Drug

Intervention Name(s)

CJ-12420 100 mg QD

Other Intervention Name(s)

Not yet decided

Intervention Description

CJ-12420 100 mg tablets will be orally administered, once daily, for up to 8 weeks. For subjects whose erosive esophagitis is not endoscopically healed at Week 4, subjects will receive additional 4 week treatment of CJ-12420 100 mg.

Intervention Type

Drug

Intervention Name(s)

Esomeprazole 40 mg QD

Other Intervention Name(s)

Nexium

Intervention Description

Esomeprazole 40 mg tablets will be orally administered, once daily, for up to 8 weeks. For subjects whose erosive esophagitis is not endoscopically healed at Week 4, subjects will receive additional 4 week treatment of Esomeprazole 40 mg.

Primary Outcome Measure Information:

Title

Cumulative healing rate of erosive esophagitis at 8-week

Time Frame

8 week

Secondary Outcome Measure Information:

Title

Healing rate of erosive esophagitis at 4-week

Time Frame

4 week

Title

Symptom assessment by subject diary and questionnaire

Time Frame

4 week or 8 week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects aged between 20 and 70 years Subjects who had experienced heartburn and regurgitation within 7 days before visit 1. Entry into study also required that patients had experienced at least mild upper gastrointestinal symptoms on at least 2 days/week or at least moderate upper gastrointestinal symptoms on at least 1 day/week Endoscopically confirmed erosive esophagitis as defined by LA Classification Grading System (A-D) within 14 days prior to randomization Subjects who is able to understand and follow the instructions and is willing to participate throughout the entire study Subjects who voluntarily signed written informed consent form Subjects who agreed to use medically acceptable contraceptives during the period of study. Exclusion Criteria: Subjects who cannot undergo EGD Subjects who have esophageal stenosis, ulcer stenosis, gastroesophageal varices, Barrett's esophagus, active gastric ulcer, gastrointestinal bleeding or malignant tumor confirmed by EGD Subjects who have warning symptoms of malignant gastrointestinal tract such as odynophagia, severe dysphagia, bleeding, weight loss, anemia, or bloody stool Subjects with eosinophilic esophagitis Subjects diagnosed with primary esophageal motility disorder, IBS, IBD, etc. or with suspected IBS in the last 3 months Subjects who have a history of gastric acid suppression surgery or upper gastrointestinal, esophageal surgery Pregnant or lactating women Subjects with a history of clinically significant hepatic, renal, cardiovascular, respiratory, endocrine and CNS system disorder Subjects with a history of hypersensitivity to the active ingredient or excipients of the study drug, etc. Subjects who participated in the other clinical trial within 4 weeks prior to randomization

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hyun Chae Jung, Ph.D

Organizational Affiliation

Seoul National University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Seoul National University Hospital

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Study to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Erosive Esophagitis

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