Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Treatment Effect According to Timing of Administration of DWP14012 40 mg

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04613895
Recruitment Status : Not yet recruiting
First Posted : November 3, 2020
Last Update Posted : November 3, 2020
Sponsor:
Collaborator:
Hanyang University
Information provided by (Responsible Party):
Daewoong Pharmaceutical Co. LTD.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Erosive Esophagitis Drug: DWP14012 Not Applicable

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 Subjects whose mucosal breaks have completely healed will be prematurely withdrawn and considered to have reached end of treatment.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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 186 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : November 17, 2020
Estimated Primary Completion Date : May 30, 2021
Estimated Study Completion Date : December 30, 2021
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: fed state group
just after a meal
 Drug: DWP14012
DWP14012 40 mg, orally, once daily just after a meal up to 4 weeks
Other Name: fed state
Experimental: fasted state group
before a meal
 Drug: DWP14012
DWP14012 40 mg, orally, once daily before a meal up to 4 weeks
Other Name: fasted state


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. healing rate at 4 week [ Time Frame: 4 week ]
    Cumulative healing rate of erosive esophagitis at 4 week by endoscopy


Secondary Outcome Measures :
  1. healing rate at 2 week [ Time Frame: 2 week ]
    Cumulative healing rate of erosive esophagitis at 2 week by endoscopy


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04613895


Contacts
Layout table for location contacts
Contact: HOJIN LEE +82-2-550-8651 hjlee200@daewoong.co.kr

Locations
Layout table for location information
Korea, Republic of
Hanyang University Medical Center
Seoul, Korea, Republic of, 04763
Sponsors and Collaborators
Daewoong Pharmaceutical Co. LTD.
Hanyang University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier: NCT04613895    
Other Study ID Numbers: IIT_DWP14012001
First Posted: November 3, 2020    Key Record Dates
Last Update Posted: November 3, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis