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

Study Overview
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Brief Summary
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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
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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).

Official Title
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A Double Blind, Randomized, Active-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Gastric Ulcer

Conditions
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Gastric Ulcer

Intervention / Treatment
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* Drug: CJ-12420 50 mg QD
* Drug: CJ-12420 100 mg QD
* Drug: Lansoprazole 30 mg QD


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CJ-12420 50 mg QD<br>CJ-12420 50 mg, tablet, once daily, oral administration for up to 8 weeks | Drug: CJ-12420 50 mg QD<br>* 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.<br>* Other names: Not yet decided;|
| Experimental: CJ-12420 100 mg QD<br>CJ-12420 100 mg, tablet, once daily, oral administration for up to 8 weeks | Drug: CJ-12420 100 mg QD<br>* 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.<br>* Other names: Not yet decided;|
| Active Comparator: Lansoprazole 30 mg QD<br>Lansoprazole 30 mg, capsule, once daily, oral administration for up to 8 weeks | Drug: Lansoprazole 30 mg QD<br>* 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.<br>* Other names: Lanston cap.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative healing rate of gastric ulcer at 8-week |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healing rate of gastric ulcer at 4-week |  | 4 weeks | 
| Week 8 healing rates by H. pylori infection |  | 8 weeks |