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

NCT ID: NCT02456935

Last Updated: 2016-12-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 280 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2016-09-30

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.

Conditions

Erosive Esophagitis

Study Design

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

Study Groups

CJ-12420 100 mg QD

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

Group Type: EXPERIMENTAL

CJ-12420 100 mg QD

Intervention Type: DRUG

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.

Esomeprazole 40 mg QD

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

Group Type: ACTIVE_COMPARATOR

Esomeprazole 40 mg QD

Intervention Type: DRUG

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.

Interventions

CJ-12420 100 mg QD

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

Esomeprazole 40 mg QD

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.

Intervention Type: DRUG

Other Intervention Names

Not yet decided; Nexium

Eligibility Criteria

Inclusion Criteria

1. Subjects aged between 20 and 70 years

2. 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

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

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. Pregnant or lactating women

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

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

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HK inno.N Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hyun Chae Jung, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

CJ_APA_301

Identifier Type: -

Identifier Source: org_study_id