Overview

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

Status:
Completed

Trial end date:
2018-12-28

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

CJ HealthCare Corporation
HK inno.N Corporation

Treatments:

Dexlansoprazole
Lansoprazole

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