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

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

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

Study Overview

• Status: Completed
• Conditions: Erosive Esophagitis
• Intervention / Treatment: Drug: CJ-12420 100 mg QD; Drug: Esomeprazole 40 mg QD

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.

• Study Type: Interventional
• Enrollment (Actual): 280
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CJ-12420 100 mg QD; CJ-12420 100 mg, tablet, once daily, oral administration for up to 8 weeks	Drug: 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.; Other Names: Not yet decided
Active Comparator: Esomeprazole 40 mg QD; Esomeprazole 40 mg, tablet, once daily, oral administration for up to 8 weeks	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.; Other Names: Nexium

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cumulative healing rate of erosive esophagitis at 8-week	8 week

Secondary Outcome Measures

Outcome Measure	Time Frame
Healing rate of erosive esophagitis at 4-week	4 week
Symptom assessment by subject diary and questionnaire	4 week or 8 week

Collaborators and Investigators

• Sponsor: HK inno.N Corporation
• Investigators: Principal Investigator: Hyun Chae Jung, Ph.D, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: May 27, 2015
• First Submitted That Met QC Criteria: May 27, 2015
• First Posted (Estimate): May 29, 2015

Study Record Updates

• Last Update Posted (Estimate): December 15, 2016
• Last Update Submitted That Met QC Criteria: December 14, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Esophageal Diseases; Esophagitis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Esomeprazole
• Other Study ID Numbers: CJ_APA_301