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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

About this trial

This is an interventional treatment trial for Gastric Ulcer

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

NCT ID

NCT02761512

First Posted

May 1, 2016

Last Updated

August 20, 2019

Sponsor

HK inno.N Corporation

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

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

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

Learn more about this trial

Study to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Gastric Ulcer

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