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

Gastric Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02761512
• Other study ID #: CJ_APA_303
• Status: Completed
• Phase: Phase 3
• Start date: May 2016
• Est. completion date: December 28, 2018

Study information

• Verified date: April 2018
• Source: CJ HealthCare Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 306
• Est. completion date: December 28, 2018
• Est. primary completion date: July 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Ulcer
• Stomach Ulcer
• Ulcer

Intervention

Drug:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Catholic Univ. Seoul St. Mary Hospita	Seoul
Korea, Republic of	Kyung Hee University Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
CJ HealthCare Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative healing rate of gastric ulcer at 8-week		8 weeks
Secondary	Healing rate of gastric ulcer at 4-week		4 weeks
Secondary	Week 8 healing rates by H. pylori infection		8 weeks