Study to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Erosive Esophagitis

HK inno.N

Status and phase: Completed; Phase 2

Conditions: Erosive Esophagitis; GERD

Treatments: Drug: Esomeprazole; Drug: CJ-12420

Study type: Interventional

Funder types: Industry

Identifiers

NCT02028663

CJ_APA_201

Details and patient eligibility

About

The purpose of this study is to investigate the optimal dose and administration methods of CJ-12420 in patients with erosive esophagitis by comparing the safety and efficacy of orally administered CJ-12420 to esomeprazole 40mg.

Enrollment: 206 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged between 20-70
• Diagnosed with Erosive Esophagitis by Esophagogastroduodenoscopy (EGD) and classified into LA Grade A to D within 14 days before randomization to treatment

Exclusion criteria

• Patients who cannot undergo EGD
• Patients diagnosed with irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), or suspected IBS
• Patients who took PPIs within 2 weeks prior to study drug administration
• Long-term use of nonsteroidal anti-inflammatory drugs throughout the study
• Clinically significant abnormal laboratory values during screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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206 participants in 4 patient groups

CJ-12420 Amg

Experimental group

Description:

50 volunteers will be administered CJ-12420 Amg

Treatment:

Drug: CJ-12420

CJ-12420 Bmg

Experimental group

Description:

50 volunteers will be administered CJ-12420 Bmg

Treatment:

Drug: CJ-12420

CJ-12420 Cmg

Experimental group

Description:

50 volunteers will be administered CJ-12420 Cmg

Treatment:

Drug: CJ-12420

Esomeprazole 40mg

Active Comparator group

Description:

50 volunteers will be administered Esomeprazole 40mg

Treatment:

Drug: Esomeprazole