NCT02028663

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
206

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 7, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

August 8, 2014

Status Verified

August 1, 2014

Enrollment Period

1 year

First QC Date

January 5, 2014

Last Update Submit

August 6, 2014

Conditions

Erosive EsophagitisGERD

Keywords

P-CABAPA(Acid Pump Antagonist)

Outcome Measures

Primary Outcomes (1)

  • Cumulative healing rate of erosive esophagitis at 8-week

    8 week

Secondary Outcomes (1)

  • Healing rate of erosive esophagitis at 4-week

    4 week

Study Arms (4)

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

CJ-12420DRUG

Once daily, Oral administration

Also known as: Undecided
CJ-12420 AmgCJ-12420 BmgCJ-12420 Cmg
EsomeprazoleDRUG

Once daily, Oral administration

Also known as: Nexium
Esomeprazole 40mg

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital and 11 others

Seoul, South Korea

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Omeprazole2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Hyun-Chae Jung, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2014

First Posted

January 7, 2014

Study Start

May 1, 2013

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

August 8, 2014

Record last verified: 2014-08

Locations

KR(1)