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

HK inno.N

Status and phase: Completed; Phase 3

Conditions: Gastric Ulcer

Treatments: Drug: CJ-12420 50 mg QD; Drug: CJ-12420 100 mg QD; Drug: Lansoprazole 30 mg QD

Study type: Interventional

Funder types: Industry

Identifiers

NCT02761512

CJ_APA_303

Details and patient eligibility

About

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.

Full 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).

Enrollment: 306 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No 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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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306 participants in 3 patient groups

CJ-12420 50 mg QD

Experimental group

Description:

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

Treatment:

Drug: CJ-12420 50 mg QD

CJ-12420 100 mg QD

Experimental group

Description:

CJ-12420 100 mg, tablet, once daily, oral administration for up to 8 weeks

Treatment:

Drug: CJ-12420 100 mg QD

Lansoprazole 30 mg QD

Active Comparator group

Description:

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

Treatment:

Drug: Lansoprazole 30 mg QD