Back to resultsStudy to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Erosive Esophagitis
Primary Purpose
Erosive Esophagitis, GERD
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CJ-12420
Esomeprazole
Sponsored by
About this trial
This is an interventional treatment trial for Erosive Esophagitis focused on measuring P-CAB, APA(Acid Pump Antagonist)
Eligibility Criteria
Inclusion Criteria:
- Aged between 20-70
- Diagnosed with Erosive Esophagitis by Esophagogastroduodenoscopy (EGD) and classified into LA Grade A to D within 14 days before randomization to treatment
Exclusion Criteria:
- Patients who cannot undergo EGD
- Patients diagnosed with irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), or suspected IBS
- Patients who took PPIs within 2 weeks prior to study drug administration
- Long-term use of nonsteroidal anti-inflammatory drugs throughout the study
- Clinically significant abnormal laboratory values during screening
Sites / Locations
- Seoul National University Hospital and 11 others
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
CJ-12420 Amg
CJ-12420 Bmg
CJ-12420 Cmg
Esomeprazole 40mg
Arm Description
50 volunteers will be administered CJ-12420 Amg
50 volunteers will be administered CJ-12420 Bmg
50 volunteers will be administered CJ-12420 Cmg
50 volunteers will be administered Esomeprazole 40mg
Outcomes
Primary Outcome Measures
Cumulative healing rate of erosive esophagitis at 8-week
Secondary Outcome Measures
Healing rate of erosive esophagitis at 4-week
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02028663
Brief Title
Study to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Erosive Esophagitis
Official Title
A Double-Blind, Randomized, Dose-finding Study to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Erosive Esophagitis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HK inno.N Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to investigate the optimal dose and administration methods of CJ-12420 in patients with erosive esophagitis by comparing the safety and efficacy of orally administered CJ-12420 to esomeprazole 40mg.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erosive Esophagitis, GERD
Keywords
P-CAB, APA(Acid Pump Antagonist)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
206 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CJ-12420 Amg
Arm Type
Experimental
Arm Description
50 volunteers will be administered CJ-12420 Amg
Arm Title
CJ-12420 Bmg
Arm Type
Experimental
Arm Description
50 volunteers will be administered CJ-12420 Bmg
Arm Title
CJ-12420 Cmg
Arm Type
Experimental
Arm Description
50 volunteers will be administered CJ-12420 Cmg
Arm Title
Esomeprazole 40mg
Arm Type
Active Comparator
Arm Description
50 volunteers will be administered Esomeprazole 40mg
Intervention Type
Drug
Intervention Name(s)
CJ-12420
Other Intervention Name(s)
Undecided
Intervention Description
Once daily, Oral administration
Intervention Type
Drug
Intervention Name(s)
Esomeprazole
Other Intervention Name(s)
Nexium
Intervention Description
Once daily, Oral administration
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged between 20-70
Diagnosed with Erosive Esophagitis by Esophagogastroduodenoscopy (EGD) and classified into LA Grade A to D within 14 days before randomization to treatment
Exclusion Criteria:
Patients who cannot undergo EGD
Patients diagnosed with irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), or suspected IBS
Patients who took PPIs within 2 weeks prior to study drug administration
Long-term use of nonsteroidal anti-inflammatory drugs throughout the study
Clinically significant abnormal laboratory values during screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyun-Chae Jung, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital and 11 others
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Study to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Erosive Esophagitis
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