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Treatment Effect According to Timing of Administration of DWP14012 40 mg

Sponsor
Daewoong Pharmaceutical Co. LTD. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT04613895
Collaborator
Hanyang University (Other)
186
Enrollment
1
Location
2
Arms
13.4
Anticipated Duration (Months)
13.9
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
N/A

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 Subjects whose mucosal breaks have completely healed will be prematurely withdrawn and considered to have reached end of treatment.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

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
Nov 17, 2020
Anticipated Primary Completion Date :
May 30, 2021
Anticipated Study Completion Date :
Dec 30, 2021

Arms and Interventions

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

    		•
    Experimental: fasted state group

    before a meal

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. healing rate at 4 week [4 week]

      Cumulative healing rate of erosive esophagitis at 4 week by endoscopy

    Secondary Outcome Measures

    1. healing rate at 2 week [2 week]

      Cumulative healing rate of erosive esophagitis at 2 week by endoscopy

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Hanyang University Medical Center Seoul Korea, Republic of 04763

    Sponsors and Collaborators

    • Daewoong Pharmaceutical Co. LTD.
    • Hanyang University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Daewoong Pharmaceutical Co. LTD.
    ClinicalTrials.gov Identifier:
    NCT04613895
    Other Study ID Numbers:
    • IIT_DWP14012001
    First Posted:
    Nov 3, 2020
    Last Update Posted:
    Nov 3, 2020
    Last Verified:
    Oct 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Esophagitis

    Study Results

    No Results Posted as of Nov 3, 2020