Study to Evaluate the Safety and Efficacy of CJ-12420 in... | NCT02028663

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

NCT02028663

Sponsor

HK inno.N Corporation

Status

Completed

Last Update Posted

Aug 8, 2014Estimated

Enrollment

206Actual

Phase

Phase 2

Conditions

Erosive Esophagitis
GERD

Interventions

CJ-12420
Esomeprazole

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2013

Primary Completion Date

May 2014Actual

Completion Date

May 2014Actual

First Submitted Date

Jan 5, 2014

First Submission Date that Met QC Criteria

Jan 6, 2014

First Posted Date

Jan 7, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 6, 2014

Last Update Posted Date

Aug 8, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

206Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CJ-12420 Amg	Experimental	50 volunteers will be administered CJ-12420 Amg	Drug: CJ-12420
CJ-12420 Bmg	Experimental	50 volunteers will be administered CJ-12420 Bmg	Drug: CJ-12420
CJ-12420 Cmg	Experimental	50 volunteers will be administered CJ-12420 Cmg	Drug: CJ-12420
Esomeprazole 40mg	Active Comparator	50 volunteers will be administered Esomeprazole 40mg	Drug: Esomeprazole

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CJ-12420	Drug	Once daily, Oral administration	CJ-12420 Amg CJ-12420 Bmg CJ-12420 Cmg

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hyun-Chae Jung, MD, PhD	Seoul National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital and 11 others		Seoul			South Korea

Condition Browse Module

MeSH Terms

ID	Term
D005764	Gastroesophageal Reflux

Ancestor Terms

ID	Term
D015154	Esophageal Motility Disorders
D003680	Deglutition Disorders
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D064098	Esomeprazole

Ancestor Terms

ID	Term
D009853	Omeprazole
D053799	2-Pyridinylmethylsulfinylbenzimidazoles
D013454	Sulfoxides
D013457	Sulfur Compounds

Browse Leaves

Not provided

Browse Branches

Not provided