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
About this trial
This is an interventional treatment trial for Erosive Esophagitis
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
Sites / Locations
- Hanyang University Medical Center
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 4 week
Cumulative healing rate of erosive esophagitis at 4 week by endoscopy
Secondary Outcome Measures
healing rate at 2 week
Cumulative healing rate of erosive esophagitis at 2 week by endoscopy
Full Information
NCT ID
NCT04613895
First Posted
October 28, 2020
Last Updated
October 28, 2020
Sponsor
Daewoong Pharmaceutical Co. LTD.
Collaborators
Hanyang University
1. Study Identification
Unique Protocol Identification Number
NCT04613895
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
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 17, 2020 (Anticipated)
Primary Completion Date
May 30, 2021 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daewoong Pharmaceutical Co. LTD.
Collaborators
Hanyang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
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. 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.
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 4 week
Description
Cumulative healing rate of erosive esophagitis at 4 week by endoscopy
Time Frame
4 week
Secondary Outcome Measure Information:
Title
healing rate at 2 week
Description
Cumulative healing rate of erosive esophagitis at 2 week by endoscopy
Time Frame
2 week
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
HOJIN LEE
Phone
+82-2-550-8651
Email
hjlee200@daewoong.co.kr
Facility Information:
Facility Name
Hanyang University Medical Center
City
Seoul
ZIP/Postal Code
04763
Country
Korea, Republic of
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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