- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04888819
Treatment Effect According to Timing of Administration of DWP14012 40 mg
May 12, 2021 updated by: Konkuk University Medical Center
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
The primary objective of this study is to establish noninferiority of efficacy of DWP14012 (40 mg once daily) based on Timing of Administration.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
186
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sun Na
- Phone Number: 82-2-2030-5027
- Email: 20190671@kuh.ac.kr
Study Locations
-
-
-
Seoul, Korea, Republic of
- Recruiting
- Konkuk University Medical Center
-
Contact:
- In-kyung Sung
- Phone Number: 82-2-2030-5010
- Email: inksung@kuh.ac.kr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: fed state group
just after a meal
|
DWP14012 40 mg, orally, once daily just after a meal up to 4 weeks
Other Names:
DWP14012 40 mg, orally, once daily before a meal up to 4 weeks
Other Names:
|
Experimental: fasted state group
before a meal
|
DWP14012 40 mg, orally, once daily just after a meal up to 4 weeks
Other Names:
DWP14012 40 mg, orally, once daily before a meal up to 4 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
healing rate at week 4
Time Frame: up to 4 weeks
|
Cumulative healing rate of erosive esophagitis at week 4 by endoscopy
|
up to 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2021
Primary Completion (Anticipated)
July 31, 2021
Study Completion (Anticipated)
December 31, 2021
Study Registration Dates
First Submitted
May 12, 2021
First Submitted That Met QC Criteria
May 12, 2021
First Posted (Actual)
May 17, 2021
Study Record Updates
Last Update Posted (Actual)
May 17, 2021
Last Update Submitted That Met QC Criteria
May 12, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIT_DWP14012001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Erosive Esophagitis
-
Braintree LaboratoriesRecruitingErosive EsophagitisUnited States
-
Phathom Pharmaceuticals, Inc.CompletedErosive EsophagitisUnited States, Poland, Bulgaria, United Kingdom, Czechia, Hungary
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Daewoong Pharmaceutical Co. LTD.Hanyang UniversityUnknownErosive EsophagitisKorea, Republic of
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TakedaCompletedEfficacy and Safety of Oral Once-Daily Vonoprazan (TAK-438) in Participants With Erosive EsophagitisErosive EsophagitisChina, Taiwan, Korea, Republic of, Malaysia
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Onconic Therapeutics Inc.RecruitingErosive EsophagitisKorea, Republic of
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AstraZenecaLaboratory Corporation of America; Medidata Solutions; IQVIA RDS Inc.; Calyx; Thermo... and other collaboratorsRecruitingErosive EsophagitisUnited States, Italy, Belgium, Vietnam, Spain, Portugal, Russian Federation, Argentina, Greece, Australia, Lithuania
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Cinclus Pharma AGParexelCompletedErosive EsophagitisPoland, Bulgaria, Serbia, Georgia, United States, Czechia, Hungary, Ukraine
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Boryung Pharmaceutical Co., LtdCompleted
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HK inno.N CorporationCompletedErosive EsophagitisKorea, Republic of
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HK inno.N CorporationCompletedErosive EsophagitisKorea, Republic of
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Daewoong Pharmaceutical Co. LTD.CompletedDrug-drug InteractionAustralia
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Daewoong Pharmaceutical Co. LTD.CompletedPhase 1 Study, Healthy VolunteersKorea, Republic of
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Daewoong Pharmaceutical Co. LTD.UnknownHealthyKorea, Republic of
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Daewoong Pharmaceutical Co. LTD.UnknownHealthyKorea, Republic of
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Daewoong Pharmaceutical Co. LTD.UnknownHealthyKorea, Republic of
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Daewoong Pharmaceutical Co. LTD.UnknownNon-Erosive Gastroesophageal Reflux DiseaseKorea, Republic of
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Daewoong Pharmaceutical Co. LTD.CompletedHealthy VolunteersKorea, Republic of
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Daewoong Pharmaceutical Co. LTD.RecruitingNon-erosive Reflux Disease | Non-Erosive Gastro-Esophageal Reflux Disease | Non-Erosive Esophageal Reflux DiseaseKorea, Republic of
-
Daewoong Pharmaceutical Co. LTD.Recruiting