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

NCT ID: NCT02028663

Last Updated: 2014-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

206 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2014-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Erosive Esophagitis GERD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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CJ-12420 Amg

50 volunteers will be administered CJ-12420 Amg

Group Type EXPERIMENTAL

CJ-12420

Intervention Type DRUG

Once daily, Oral administration

CJ-12420 Bmg

50 volunteers will be administered CJ-12420 Bmg

Group Type EXPERIMENTAL

CJ-12420

Intervention Type DRUG

Once daily, Oral administration

CJ-12420 Cmg

50 volunteers will be administered CJ-12420 Cmg

Group Type EXPERIMENTAL

CJ-12420

Intervention Type DRUG

Once daily, Oral administration

Esomeprazole 40mg

50 volunteers will be administered Esomeprazole 40mg

Group Type ACTIVE_COMPARATOR

Esomeprazole

Intervention Type DRUG

Once daily, Oral administration

Interventions

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CJ-12420

Once daily, Oral administration

Intervention Type DRUG

Esomeprazole

Once daily, Oral administration

Intervention Type DRUG

Other Intervention Names

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Undecided Nexium

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HK inno.N Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hyun-Chae Jung, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital and 11 others

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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CJ_APA_201

Identifier Type: -

Identifier Source: org_study_id

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