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

NCT ID: NCT03006874

Last Updated: 2017-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 302 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-02
• Study Completion Date: 2017-03-24

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.

Conditions

Erosive Esophagitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

CJ-12420 50mg QD

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

Group Type: EXPERIMENTAL

CJ-12420 50mg QD

Intervention Type: DRUG

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.

CJ-12420 100mg QD

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

Group Type: EXPERIMENTAL

CJ-12420 100mg QD

Intervention Type: DRUG

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.

Esomeprazole 40mg

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

Group Type: ACTIVE_COMPARATOR

Esomeprazole 40mg

Intervention Type: DRUG

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.

Interventions

CJ-12420 100mg QD

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

Esomeprazole 40mg

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

CJ-12420 50mg QD

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.

Intervention Type: DRUG

Other Intervention Names

Tegoprazan Tab.; Nexium Tab.; Tegoprazan Tab.

Eligibility Criteria

Inclusion Criteria

1. Subjects aged between 20 and 75 years

2. Endoscopically confirmed erosive esophagitis as defined by LA Classification Grading System (A-D) within 14 days prior to randomization

3. Subjects who had experienced heartburn and regurgitation within 7 days before visit 1

4. Subjects who is able to understand and follow the instructions and is willing to participate throughout the entire study

5. Subjects who voluntarily signed written informed consent form

6. Subjects who agreed to use medically acceptable contraceptives during the period of study

Exclusion Criteria

1. Subjects who cannot undergo EGD

2. Subjects who have esophageal stenosis, ulcer stenosis, gastroesophageal varices, Barrett's esophagus, active gastric ulcer, gastrointestinal bleeding or malignant tumor confirmed by EGD

3. Subjects who have warning symptoms of malignant gastrointestinal tract such as odynophagia, severe dysphagia, bleeding, weight loss, anemia, or bloody stool

4. Subjects with eosinophilic esophagitis

5. Subjects diagnosed with primary esophageal motility disorder, IBS, IBD, etc. or with suspected IBS in the last 3 months

6. Subjects who have a history of gastric acid suppression surgery or upper gastrointestinal, esophageal surgery

7. Subjects who have AIDS or Hepatitis

8. Subjects who take antipsychotic drugs, antidepressant drug, antianxiety drug

9. Subjects who take gastric acid suppression like PPI within 2 weeks to EGD

10. Subjects who take medications related to reflux esophagitis more than 2 times within 1 weeks to EGD

11. 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

12. Pregnant or lactating women

13. Subjects with the following clinically significant laboratory abnormalities

14. Subjects with the following clinically significant ECG abnormalities

15. Sollinger-Ellison syndrome patients

16. Subjects with a history of malignant tumor

17. Subjects with a history of clinically significant hepatic, renal, cardiovascular, respiratory, endocrine and CNS system disorder

18. Subjects with a history of hypersensitivity to the active ingredient or excipients of the study drug, etc

19. Scheduled surgery requiring hospitalization or requirement of surgical treatment during study participation

20. Subjects who participated in the other clinical trial within 4 weeks prior to randomization

21. Subjects who are judged unsuitable to participate in the study in the opinion of the investigator

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HK inno.N Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Poong Ryul Lee, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

Samsung Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

CJ_APA_304

Identifier Type: -

Identifier Source: org_study_id