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Study to Confirm 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 100mg QD

Esomeprazole 40mg

CJ-12420 50mg QD

About this trial

This is an interventional treatment trial for Erosive Esophagitis

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects aged between 20 and 75 years
Endoscopically confirmed erosive esophagitis as defined by LA Classification Grading System (A-D) within 14 days prior to randomization
Subjects who had experienced heartburn and regurgitation within 7 days before visit 1
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
Subjects who have AIDS or Hepatitis
Subjects who take antipsychotic drugs, antidepressant drug, antianxiety drug
Subjects who take gastric acid suppression like PPI within 2 weeks to EGD
Subjects who take medications related to reflux esophagitis more than 2 times within 1 weeks to EGD
Requirement of persistent daily use of drugs that may cause an ulcer such as nonsteroidal anti-inflammatory drugs(NSAIDs) or aspirin during the course of the study
Pregnant or lactating women
Subjects with the following clinically significant laboratory abnormalities
Subjects with the following clinically significant ECG abnormalities
Sollinger-Ellison syndrome patients
Subjects with a history of malignant tumor
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
Scheduled surgery requiring hospitalization or requirement of surgical treatment during study participation
Subjects who participated in the other clinical trial within 4 weeks prior to randomization
Subjects who are judged unsuitable to participate in the study in the opinion of the investigator

Sites / Locations

Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

CJ-12420 50mg QD

CJ-12420 100mg QD

Esomeprazole 40mg

Arm Description

CJ-12420 50mg tablet, once daily, oral administration for up to 8 weeks.

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

Esomeprazole 40mg, 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

Symptom assessment by questionnaire

Full Information

NCT ID

NCT03006874

First Posted

June 14, 2016

Last Updated

September 11, 2017

Sponsor

HK inno.N Corporation

1. Study Identification

Unique Protocol Identification Number

NCT03006874

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Completed

Study Start Date

May 2, 2016 (Actual)

Primary Completion Date

March 24, 2017 (Actual)

Study Completion Date

March 24, 2017 (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 confirm 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 three treatment groups (CJ-12420 50mg, CJ-12420 100mg, esomeprazole 40mg). All subjects will be asked to take three 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

302 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CJ-12420 50mg QD

Arm Type

Experimental

Arm Description

CJ-12420 50mg tablet, once daily, oral administration for up to 8 weeks.

Arm Title

CJ-12420 100mg QD

Arm Type

Experimental

Arm Description

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

Arm Title

Esomeprazole 40mg

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

CJ-12420 100mg QD

Other Intervention Name(s)

Tegoprazan Tab.

Intervention Description

CJ-12420 100mg 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 100mg.

Intervention Type

Drug

Intervention Name(s)

Esomeprazole 40mg

Other Intervention Name(s)

Nexium Tab.

Intervention Description

Esomeprazole 40mg 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 40mg.

Intervention Type

Drug

Intervention Name(s)

CJ-12420 50mg QD

Other Intervention Name(s)

Tegoprazan Tab.

Intervention Description

CJ-12420 50mg 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 50mg.

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

Time Frame

4-week or 8-week

Title

Symptom assessment by questionnaire

Time Frame

4-week or 8-week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects aged between 20 and 75 years Endoscopically confirmed erosive esophagitis as defined by LA Classification Grading System (A-D) within 14 days prior to randomization Subjects who had experienced heartburn and regurgitation within 7 days before visit 1 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 Subjects who have AIDS or Hepatitis Subjects who take antipsychotic drugs, antidepressant drug, antianxiety drug Subjects who take gastric acid suppression like PPI within 2 weeks to EGD Subjects who take medications related to reflux esophagitis more than 2 times within 1 weeks to EGD Requirement of persistent daily use of drugs that may cause an ulcer such as nonsteroidal anti-inflammatory drugs(NSAIDs) or aspirin during the course of the study Pregnant or lactating women Subjects with the following clinically significant laboratory abnormalities Subjects with the following clinically significant ECG abnormalities Sollinger-Ellison syndrome patients Subjects with a history of malignant tumor 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 Scheduled surgery requiring hospitalization or requirement of surgical treatment during study participation Subjects who participated in the other clinical trial within 4 weeks prior to randomization Subjects who are judged unsuitable to participate in the study in the opinion of the investigator

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Poong Ryul Lee, Ph.D

Organizational Affiliation

Samsung Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Samsung Medical Center

City

Seoul

ZIP/Postal Code

135-710

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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