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Treatment Effect According to Timing of Administration of DWP14012 40 mg

Primary Purpose

Erosive Esophagitis

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
DWP14012
DWP14012
Sponsored by
Konkuk University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erosive Esophagitis

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Konkuk University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

fed state group

fasted state group

Arm Description

just after a meal

before a meal

Outcomes

Primary Outcome Measures

healing rate at week 4
Cumulative healing rate of erosive esophagitis at week 4 by endoscopy

Secondary Outcome Measures

Full Information

First Posted
May 12, 2021
Last Updated
May 12, 2021
Sponsor
Konkuk University Medical Center
Collaborators
Daewoong Pharmaceutical Co. LTD.
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1. Study Identification

Unique Protocol Identification Number
NCT04888819
Brief Title
Treatment Effect According to Timing of Administration of DWP14012 40 mg
Official Title
A Multi-Center, Open-label, Randomized Trial to Evaluate the Efficacy and Safety Based on Timing of Administration of DWP14012 in Patients With Erosive Esophagitis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
July 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Konkuk University Medical Center
Collaborators
Daewoong Pharmaceutical Co. LTD.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erosive Esophagitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
186 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
fed state group
Arm Type
Experimental
Arm Description
just after a meal
Arm Title
fasted state group
Arm Type
Experimental
Arm Description
before a meal
Intervention Type
Drug
Intervention Name(s)
DWP14012
Other Intervention Name(s)
fed state
Intervention Description
DWP14012 40 mg, orally, once daily just after a meal up to 4 weeks
Intervention Type
Drug
Intervention Name(s)
DWP14012
Other Intervention Name(s)
fasted state
Intervention Description
DWP14012 40 mg, orally, once daily before a meal up to 4 weeks
Primary Outcome Measure Information:
Title
healing rate at week 4
Description
Cumulative healing rate of erosive esophagitis at week 4 by endoscopy
Time Frame
up to 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sun Na
Phone
82-2-2030-5027
Email
20190671@kuh.ac.kr
Facility Information:
Facility Name
Konkuk University Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
In-kyung Sung
Phone
82-2-2030-5010
Email
inksung@kuh.ac.kr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Treatment Effect According to Timing of Administration of DWP14012 40 mg

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