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Treatment Effect According to Timing of Administration of DWP14012 40 mg

NCT ID: NCT04613895

Last Updated: 2020-11-03

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

186 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-17

Study Completion Date

2021-12-30

Brief Summary

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

Detailed Description

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Subjects will provide written informed consent for study participation and then undergo appropriate screening. Subjects who meet the inclusion criteria and none of the exclusion criteria will be randomized in a 1:1 ratio to either before meal group or after meal group. Subjects will be stratified into two groups according to Los Angeles classification grades (LA grades) A/B or C/D, as determined by upper gastrointestinal (GI) endoscopy. Subjects will visit the site at Week 2 for endoscopic assessment. Subjects whose mucosal breaks have completely healed will be prematurely withdrawn and considered to have reached end of treatment. Subjects whose mucosal breaks have not healed will continue to receive IPs for an additional 2 weeks and will visit the site for endoscopic assessment at Week 4.

Conditions

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Erosive Esophagitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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fed state group

just after a meal

Group Type EXPERIMENTAL

DWP14012

Intervention Type DRUG

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

fasted state group

before a meal

Group Type EXPERIMENTAL

DWP14012

Intervention Type DRUG

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

Interventions

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DWP14012

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

Intervention Type DRUG

DWP14012

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

Intervention Type DRUG

Other Intervention Names

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fed state fasted state

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hanyang University

OTHER

Sponsor Role collaborator

Daewoong Pharmaceutical Co. LTD.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hanyang University Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Central Contacts

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HOJIN LEE

Role: CONTACT

[email protected]
+82-2-550-8651

Other Identifiers

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IIT_DWP14012001

Identifier Type: -

Identifier Source: org_study_id