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

NCT ID: NCT02761512

Last Updated: 2019-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 306 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2018-12-28

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).

Conditions

Gastric Ulcer

Study Design

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

Study Groups

CJ-12420 50 mg QD

CJ-12420 50 mg, tablet, once daily, oral administration for up to 8 weeks

Group Type: EXPERIMENTAL

CJ-12420 50 mg QD

Intervention Type: DRUG

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.

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 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.

Lansoprazole 30 mg QD

Lansoprazole 30 mg, capsule, once daily, oral administration for up to 8 weeks

Group Type: ACTIVE_COMPARATOR

Lansoprazole 30 mg QD

Intervention Type: DRUG

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.

Interventions

CJ-12420 50 mg QD

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

CJ-12420 100 mg QD

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

Lansoprazole 30 mg QD

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.

Intervention Type: DRUG

Other Intervention Names

Not yet decided; Not yet decided; Lanston cap.

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

1. 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.

2. Ulcer caused by an endoscopic surgery (e.g., ulcer after EMR/ESD)

3. 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

4. Scheduled surgery requiring hospitalization or requirement of surgical treatment during study participation

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HK inno.N Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Myung Gyu Choi, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Catholic Univ. Seoul St. Mary Hospital

Locations

Catholic Univ. Seoul St. Mary Hospita

Seoul, , South Korea

Kyung Hee University Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

CJ_APA_303

Identifier Type: -

Identifier Source: org_study_id