NCT04888819

Brief Summary

The primary objective of this study is to establish noninferiority of efficacy of DWP14012 (40 mg once daily) based on Timing of Administration.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
186

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

February 1, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 17, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

May 17, 2021

Status Verified

May 1, 2021

Enrollment Period

6 months

First QC Date

May 12, 2021

Last Update Submit

May 12, 2021

Conditions

Erosive Esophagitis

Outcome Measures

Primary Outcomes (1)

  • healing rate at week 4

    Cumulative healing rate of erosive esophagitis at week 4 by endoscopy

    up to 4 weeks

Study Arms (2)

fed state group

EXPERIMENTAL

just after a meal

Drug: DWP14012

fasted state group

EXPERIMENTAL

before a meal

Drug: DWP14012

Interventions

DWP14012DRUG

DWP14012 40 mg, orally, once daily just after a meal up to 4 weeks

Also known as: fed state
fed state group

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults between 19 and 75 years old based on the date of written agreement
  • Those who have been diagnosed with erosive esophagitis of LA Grade A-D on the upper gastrointestinal endoscopy
  • Those who experienced symptoms of heartburn or acid regurgitation within the last 7 days

You may not qualify if:

  • Those who have undergone gastric acid suppression or gastric, esophageal surgery
  • Those who with clinically significant liver, kidney, nervous system, respiratory, endocrine, hematologic, cardiovascular, urinary system disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konkuk University Medical Center

Seoul, South Korea

RECRUITING

MeSH Terms

Interventions

fexuprazan

Central Study Contacts

Sun Na

CONTACT

82-2-2030-502720190671@kuh.ac.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2021

First Posted

May 17, 2021

Study Start

February 1, 2021

Primary Completion

July 31, 2021

Study Completion

December 31, 2021

Last Updated

May 17, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)