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

August 6, 2014 updated by: HK inno.N Corporation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

206

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Seoul National University Hospital and 11 others

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CJ-12420 Amg
50 volunteers will be administered CJ-12420 Amg
Drug: CJ-12420
Once daily, Oral administration
Other Names:
  • Undecided
Experimental: CJ-12420 Bmg
50 volunteers will be administered CJ-12420 Bmg
Drug: CJ-12420
Once daily, Oral administration
Other Names:
  • Undecided
Experimental: CJ-12420 Cmg
50 volunteers will be administered CJ-12420 Cmg
Drug: CJ-12420
Once daily, Oral administration
Other Names:
  • Undecided
Active Comparator: Esomeprazole 40mg
50 volunteers will be administered Esomeprazole 40mg
Drug: Esomeprazole
Once daily, Oral administration
Other Names:
  • Nexium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cumulative healing rate of erosive esophagitis at 8-week
Time Frame: 8 week
8 week

Secondary Outcome Measures

Outcome Measure
Time Frame
Healing rate of erosive esophagitis at 4-week
Time Frame: 4 week
4 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HK inno.N Corporation

Investigators

  • Principal Investigator: Hyun-Chae Jung, MD, PhD, Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

January 5, 2014

First Submitted That Met QC Criteria

January 6, 2014

First Posted (Estimate)

January 7, 2014

Study Record Updates

Last Update Posted (Estimate)

August 8, 2014

Last Update Submitted That Met QC Criteria

August 6, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CJ_APA_201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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