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NCT02028663 Clinical Trial

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

GERD Clinical Trial

Official title:
A Double-Blind, Randomized, Dose-finding Study to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Erosive Esophagitis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02028663
Other study ID # CJ_APA_201
Secondary ID
Status Completed
Phase Phase 2
First received January 5, 2014
Last updated August 6, 2014
Start date May 2013
Est. completion date May 2014

Study information
Verified date August 2014
Source CJ HealthCare Corporation
Contact n/a
Is FDA regulated No
Health authority Korea: Ministry of Food and Drug Safety
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 206
Est. completion date May 2014
Est. primary completion date May 2014
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 70 Years
Eligibility 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-in?ammatory drugs throughout the study

- Clinically significant abnormal laboratory values during screening

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• CJ-12420
Once daily, Oral administration
• Esomeprazole
Once daily, Oral administration

Locations
Country Name City State
Korea, Republic of Seoul National University Hospital and 11 others 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 erosive esophagitis at 8-week 8 week No
Secondary Healing rate of erosive esophagitis at 4-week 4 week No
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