Treatment Effect According to Timing of Administration of DWP14012 40 mg

October 28, 2020 updated by: Daewoong Pharmaceutical Co. LTD.

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

Unknown

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. 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 Subjects whose mucosal breaks have completely healed will be prematurely withdrawn and considered to have reached end of treatment.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 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

Study Locations

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
Drug: DWP14012
DWP14012 40 mg, orally, once daily just after a meal up to 4 weeks
Other Names:
  • fed state
Drug: DWP14012
DWP14012 40 mg, orally, once daily before a meal up to 4 weeks
Other Names:
  • fasted state
Experimental: fasted state group
before a meal
Drug: DWP14012
DWP14012 40 mg, orally, once daily just after a meal up to 4 weeks
Other Names:
  • fed state
Drug: DWP14012
DWP14012 40 mg, orally, once daily before a meal up to 4 weeks
Other Names:
  • fasted state

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
healing rate at 4 week
Time Frame: 4 week
Cumulative healing rate of erosive esophagitis at 4 week by endoscopy
4 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
healing rate at 2 week
Time Frame: 2 week
Cumulative healing rate of erosive esophagitis at 2 week by endoscopy
2 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daewoong Pharmaceutical Co. LTD.

Collaborators

Hanyang University

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 (Anticipated)

November 17, 2020

Primary Completion (Anticipated)

May 30, 2021

Study Completion (Anticipated)

December 30, 2021

Study Registration Dates

First Submitted

October 28, 2020

First Submitted That Met QC Criteria

October 28, 2020

First Posted (Actual)

November 3, 2020

Study Record Updates

Last Update Posted (Actual)

November 3, 2020

Last Update Submitted That Met QC Criteria

October 28, 2020

Last Verified

October 1, 2020

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.

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