Study to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Gastric Ulcer
Primary Purpose
Gastric Ulcer
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CJ-12420 50 mg QD
CJ-12420 100 mg QD
Lansoprazole 30 mg QD
Sponsored by

About this trial
This is an interventional treatment trial for Gastric Ulcer
Eligibility Criteria
Inclusion Criteria:
1. Diagnosis of 1 or more active gastric ulcers (≥3 mm ~ ≤30 mm using open biopsy forceps) according to the Sakita-Miwa classification (A1 or A2 stage) from upper GI endoscopy at the same institution within 14 days prior to initiation of the investigational product administration.
Exclusion Criteria:
- Finding of gastrointestinal bleeding, esophageal stricture, ulcer stenosis, pyloric stenosis, esophageal gastric varices, Barrett's esophageal of >3 cm (long segment Barrett esophagus, LSBE), duodenal ulcer, intractable ulcer, digestive ulcer perforation or malignancy on upper GI endoscopy.
- Ulcer caused by an endoscopic surgery (e.g., ulcer after EMR/ESD)
- 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
- Scheduled surgery requiring hospitalization or requirement of surgical treatment during study participation
- Subjects who participated in the other clinical trial within 4 weeks prior to randomization
Sites / Locations
- Catholic Univ. Seoul St. Mary Hospita
- Kyung Hee University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
CJ-12420 50 mg QD
CJ-12420 100 mg QD
Lansoprazole 30 mg QD
Arm Description
CJ-12420 50 mg, tablet, once daily, oral administration for up to 8 weeks
CJ-12420 100 mg, tablet, once daily, oral administration for up to 8 weeks
Lansoprazole 30 mg, capsule, once daily, oral administration for up to 8 weeks
Outcomes
Primary Outcome Measures
Cumulative healing rate of gastric ulcer at 8-week
Secondary Outcome Measures
Healing rate of gastric ulcer at 4-week
Week 8 healing rates by H. pylori infection
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02761512
Brief Title
Study to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Gastric Ulcer
Official Title
A Double Blind, Randomized, Active-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Gastric Ulcer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
July 26, 2018 (Actual)
Study Completion Date
December 28, 2018 (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
To demonstrate non-inferiority of CJ-12420 to lansoprazole 30 mg capsule in terms of therapeutic efficacy, and to confirm safety of CJ-12420, after once daily oral administration of CJ-12420 50 mg, 100 mg or Lansoprazole 30 mg capsule in gastric ulcer patients.
Detailed Description
This is a double blind, randomized, placebo-controlled, phase 3 study. Subjects will be randomly assigned to one of the three treatment groups (CJ-12420 50 mg, 100 mg or Lansoprazole 30 mg).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Ulcer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
306 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CJ-12420 50 mg QD
Arm Type
Experimental
Arm Description
CJ-12420 50 mg, tablet, once daily, oral administration for up to 8 weeks
Arm Title
CJ-12420 100 mg QD
Arm Type
Experimental
Arm Description
CJ-12420 100 mg, tablet, once daily, oral administration for up to 8 weeks
Arm Title
Lansoprazole 30 mg QD
Arm Type
Active Comparator
Arm Description
Lansoprazole 30 mg, capsule, once daily, oral administration for up to 8 weeks
Intervention Type
Drug
Intervention Name(s)
CJ-12420 50 mg QD
Other Intervention Name(s)
Not yet decided
Intervention Description
CJ-12420 50 mg tablets will be orally administered, once daily, for up to 8 weeks. For subjects whose gastric ulcer is not endoscopically healed(S1 or S2 stage) at Week 4, subjects will receive additional 4 weeks treatment of CJ-12420 50 mg.
Intervention Type
Drug
Intervention Name(s)
CJ-12420 100 mg QD
Other Intervention Name(s)
Not yet decided
Intervention Description
CJ-12420 100 mg tablets will be orally administered, once daily, for up to 8 weeks. For subjects whose gastric ulcer is not endoscopically healed(S1 or S2 stage) at Week 4, subjects will receive additional 4 weeks treatment of CJ-12420 100 mg.
Intervention Type
Drug
Intervention Name(s)
Lansoprazole 30 mg QD
Other Intervention Name(s)
Lanston cap.
Intervention Description
Lansoprazole 30 mg capsule will be orally administered, once daily, for up to 8 weeks. For subjects whose gastric ulcer is not endoscopically healed(S1 or S2 stage) at Week 4, subjects will receive additional 4 weeks treatment of Lansoprazole 30 mg.
Primary Outcome Measure Information:
Title
Cumulative healing rate of gastric ulcer at 8-week
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Healing rate of gastric ulcer at 4-week
Time Frame
4 weeks
Title
Week 8 healing rates by H. pylori infection
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1. Diagnosis of 1 or more active gastric ulcers (≥3 mm ~ ≤30 mm using open biopsy forceps) according to the Sakita-Miwa classification (A1 or A2 stage) from upper GI endoscopy at the same institution within 14 days prior to initiation of the investigational product administration.
Exclusion Criteria:
Finding of gastrointestinal bleeding, esophageal stricture, ulcer stenosis, pyloric stenosis, esophageal gastric varices, Barrett's esophageal of >3 cm (long segment Barrett esophagus, LSBE), duodenal ulcer, intractable ulcer, digestive ulcer perforation or malignancy on upper GI endoscopy.
Ulcer caused by an endoscopic surgery (e.g., ulcer after EMR/ESD)
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
Scheduled surgery requiring hospitalization or requirement of surgical treatment during study participation
Subjects who participated in the other clinical trial within 4 weeks prior to randomization
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Myung Gyu Choi, M.D., Ph.D
Organizational Affiliation
Catholic Univ. Seoul St. Mary Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Catholic Univ. Seoul St. Mary Hospita
City
Seoul
Country
Korea, Republic of
Facility Name
Kyung Hee University Medical Center
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Gastric Ulcer
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