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

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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

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

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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