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

Phase 3

Completed

• Conditions: Gastric Ulcer
• Interventions: Drug: CJ-12420 50 mg QD; Drug: Lansoprazole 30 mg QD; Drug: CJ-12420 100 mg QD

• Registration Number: NCT02761512
• Lead Sponsor: HK inno.N Corporation

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).

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-05-01
• Study First Submitted QC: 2016-05-03
• Study First Posted: 2016-05-04
• Status Verified: 2018-04
• Primary Completion: 2018-07-26
• Study Completion: 2018-12-28
• Last Update Submitted: 2019-08-20
• Last Update Posted: 2019-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 306

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CJ-12420 50 mg QD	CJ-12420 50 mg QD	CJ-12420 50 mg, tablet, once daily, oral administration for up to 8 weeks
Lansoprazole 30 mg QD	Lansoprazole 30 mg QD	Lansoprazole 30 mg, capsule, once daily, oral administration for up to 8 weeks
CJ-12420 100 mg QD	CJ-12420 100 mg QD	CJ-12420 100 mg, tablet, once daily, oral administration for up to 8 weeks

Primary Outcome Measures

Name	Time	Method
Cumulative healing rate of gastric ulcer at 8-week	8 weeks

Secondary Outcome Measures

Name	Time	Method
Healing rate of gastric ulcer at 4-week	4 weeks
Week 8 healing rates by H. pylori infection	8 weeks

Trial Locations

Locations (2)

Kyung Hee University Medical Center; 🇰🇷 Seoul, Korea, Republic of

Catholic Univ. Seoul St. Mary Hospita; 🇰🇷 Seoul, Korea, Republic of