NCT04341454

Brief Summary

The purpose of study is to confirm the efficacy of DWP14012 X mg QD, DWP14012 Y mg BID compared to placebo in patients with Acute or Chronic Gastritis

Trial Health

87
On Track

Trial Health Score

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

Enrollment
327

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jun 2020

Shorter than P25 for phase_3

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

First Submitted

Initial submission to the registry

April 9, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 10, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

June 2, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 4, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2021

Completed
Last Updated

December 21, 2021

Status Verified

December 1, 2021

Enrollment Period

1.2 years

First QC Date

April 9, 2020

Last Update Submit

December 20, 2021

Conditions

Acute GastritisChronic Gastritis

Outcome Measures

Primary Outcomes (1)

  • Improvement rate of gastric mucosal erosion

    Improvement rate (%) = (Number of effective cases(change of ≥ 50% in erosion score) / Number of target cases) x 100

    at 2 weeks after the IP administration

Secondary Outcomes (5)

  • Cure rate of gastric mucosal erosion

    at 2 weeks after the IP administration

  • Cure rate of gastric mucosal edema

    at 2 weeks after the IP administration

  • Improvement rate of gastric mucosal erythema

    at 2 weeks after the IP administration

  • Improvement rate of gastric mucosal bleeding

    at 2 weeks after the IP administration

  • Improvement rate of subjective symptoms

    at 2 weeks after the IP administration

Study Arms (3)

DWP14012 X mg QD

EXPERIMENTAL

* Morning: 1 tablet of DWP14012 X mg + 1 tablet of DWP14012 Y mg placebo * Evening: 1 tablet of DWP14012 Y mg placebo

Drug: DWP14012 X mgDrug: DWP14012 Y mg placebo

DWP14012 Y mg BID

EXPERIMENTAL

* Morning: 1 tablet of DWP14012 X mg placebo + 1 tablet of DWP14012 Y mg * Evening: 1 tablet of DWP14012 Y mg

Drug: DWP14012 X mg placeboDrug: DWP14012 Y mg

placebo

PLACEBO COMPARATOR

* Morning: 1 tablet of DWP14012 X mg placebo + 1 tablet of DWP14012 Y mg placebo * Evening: 1 tablet of DWP14012 Y mg placebo

Drug: DWP14012 X mg placeboDrug: DWP14012 Y mg placebo

Interventions

DWP14012 X mgDRUG

DWP14012 X mg, tablet, orally, once daily for 2 weeks

DWP14012 X mg QD
DWP14012 X mg placeboDRUG

DWP14012 X mg placebo-matching tablet, orally, once daily for 2 weeks

DWP14012 Y mg BIDplacebo
DWP14012 Y mgDRUG

DWP14012 Y mg, tablet, orally, twice daily for 2 weeks

DWP14012 Y mg BID
DWP14012 Y mg placeboDRUG

DWP14012 Y mg placebo-matching tablet, orally, twice daily for 2 weeks

DWP14012 X mg QDplacebo

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 are diagnosed with acute or chronic gastritis with at least one erosion observed on upper gastrointestinal endoscopy
  • Those who had experienced one or more subjective symptoms of gastritis

You may not qualify if:

  • Those who have had surgery to reduce gastric acid secretion, or gastric or esophageal surgery
  • Those with history of clinically significant hepatic, renal, neurologic, pulmonary, endocrine, hematologic, cardiovascular or genitourinary disease that could affect the study results

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hanyang University Medical Center

Seoul, South Korea

Location

Related Publications (1)

  • Kim GH, Choi MG, Kim JI, Lee ST, Chun HJ, Lee KL, Choi SC, Jang JY, Lee YC, Kim JG, Kim KB, Shim KN, Sohn CI, Kim SK, Kim SG, Jang JS, Kim N, Jung HY, Park H, Huh KC, Lee KJ, Hong SJ, Baek S, Han JJ, Lee OY. Efficacy and Safety of Fexuprazan in Patients with Acute or Chronic Gastritis. Gut Liver. 2023 Nov 15;17(6):884-893. doi: 10.5009/gnl220457. Epub 2023 Feb 15.

    PMID: 36789577DERIVED

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2020

First Posted

April 10, 2020

Study Start

June 2, 2020

Primary Completion

August 4, 2021

Study Completion

September 16, 2021

Last Updated

December 21, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)