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

Erosive Esophagitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03006874
• Other study ID #: CJ_APA_304
• Status: Completed
• Phase: Phase 3
• First received: June 14, 2016
• Last updated: September 11, 2017
• Start date: May 2, 2016
• Est. completion date: March 24, 2017

Study information

• Verified date: September 2017
• Source: CJ HealthCare Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 302
• Est. completion date: March 24, 2017
• Est. primary completion date: March 24, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Erosive Esophagitis
• Esophagitis

Intervention

Drug:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
CJ HealthCare Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative healing rate of erosive esophagitis at 8-week		8 week
Secondary	Healing rate of erosive esophagitis at 4-week		4-week
Secondary	Symptom assessment by subject diary		4-week or 8-week
Secondary	Symptom assessment by questionnaire		4-week or 8-week