Treatment Effect According to Timing of Administration of DWP14012 40 mg
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
1 other identifier
interventional
186
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2020
CompletedFirst Posted
Study publicly available on registry
November 3, 2020
CompletedStudy Start
First participant enrolled
November 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2021
CompletedNovember 3, 2020
October 1, 2020
6 months
October 28, 2020
October 28, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
healing rate at 4 week
Cumulative healing rate of erosive esophagitis at 4 week by endoscopy
4 week
Secondary Outcomes (1)
healing rate at 2 week
2 week
Study Arms (2)
fed state group
EXPERIMENTALjust after a meal
fasted state group
EXPERIMENTALbefore a meal
Interventions
DWP14012 40 mg, orally, once daily just after a meal up to 4 weeks
Eligibility Criteria
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
- Daewoong Pharmaceutical Co. LTD.lead
- Hanyang Universitycollaborator
Study Sites (1)
Hanyang University Medical Center
Seoul, 04763, South Korea
MeSH Terms
Interventions
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2020
First Posted
November 3, 2020
Study Start
November 17, 2020
Primary Completion
May 30, 2021
Study Completion
December 30, 2021
Last Updated
November 3, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share