Back to resultsStudy to Evaluate the Efficacy and Safety of DWP14012 on Maintaining Healing in Subjects With Healed Erosive Esophagitis
Primary Purpose
Healed Erosive Esophagitis
Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
DWP14012 20 mg
DWP14012 20 mg placebo
Lansoprazole 15 mg
Lansoprazole 15 mg Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Healed Erosive Esophagitis
Eligibility Criteria
Inclusion Criteria:
- Male and female adults aged 19 to 75 years, at the date the written informed consent form is signed
- Subjects with erosive esophagitis (LA Grade A-D) confirmed on EGD within 12 weeks from Visit 2 (randomization day)
- Subjects with healed erosive esophagitis (no mucosal break observed according to LA classification) confirmed on EGD performed within 10 days before Visit 2 (randomization day) after receiving the standard dose of medicinal products of erosive esophagitis (PPI, P-CAB, etc.) for 4 to 8 weeks for the treatment of erosive esophagitis
Exclusion Criteria:
- Subjects who have Barrett's esophagus (> 3 cm), gastroesophageal varix, esophagostenosis, ulcer stenosis, active peptic ulcer, acute gastrointestinal bleeding, or a malignant tumor upon EGD screening
- Subjects who have inflammatory bowel disease (Crohn disease, ulcerative colitis, etc.), irritable bowel syndrome (IBS), primary esophageal motility, or pancreatitis.
- Subjects with history of clinically significant disease of hepatic, renal, nervous, pulmonary, endocrine, hemato-oncologic, cardiovascular or urinary system
- Subjects who have had a malignant tumor in the last 5 years
- Subjects who must continue to take non-steroidal anti-inflammatory drugs (aspirin, etc.), antithrombotic drugs, etc. during the study period (A low dose of aspirin [100 mg/day] which has been administered for prophylactic purpose before study entry is allowed)
- Subjects who cannot stop the existing erosive esophagitis treatment being taken
Sites / Locations
- The Catholic University of Korea, Yeouido ST. Mary's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
DWP14012 20mg
Lansoprazole 15mg
Arm Description
Orally, once daily
Orally, once daily
Outcomes
Primary Outcome Measures
Proportion (%) of subjects with remission maintained on esophagogastroduodenoscopy by Week 24
Secondary Outcome Measures
Proportion (%) of subjects with remission maintained on esophagogastroduodenoscopy by Week 12
Full Information
NCT ID
NCT04341428
First Posted
April 9, 2020
Last Updated
September 1, 2020
Sponsor
Daewoong Pharmaceutical Co. LTD.
1. Study Identification
Unique Protocol Identification Number
NCT04341428
Brief Title
Study to Evaluate the Efficacy and Safety of DWP14012 on Maintaining Healing in Subjects With Healed Erosive Esophagitis
Official Title
A Multi-center, Double-Blind, Randomized, Active-controlled, Parallel-group, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DWP14012 as Maintenance Therapy in Patients With Healed Erosive Esophagitis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 2, 2020 (Actual)
Primary Completion Date
August 30, 2021 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daewoong Pharmaceutical Co. LTD.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aims to demonstrate the noninferiority of DWP14012 to Lansoprazole 15 mg in the maintenance effect of treatment and confirm the safety of DWP14012 in patients with healed erosive esophagitis confirmed on EGD after medication treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healed Erosive Esophagitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
406 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DWP14012 20mg
Arm Type
Experimental
Arm Description
Orally, once daily
Arm Title
Lansoprazole 15mg
Arm Type
Active Comparator
Arm Description
Orally, once daily
Intervention Type
Drug
Intervention Name(s)
DWP14012 20 mg
Intervention Description
DWP14012 20 mg, tablet, orally, once daily for up to 24 weeks
Intervention Type
Drug
Intervention Name(s)
DWP14012 20 mg placebo
Intervention Description
DWP14012 20 mg placebo-matching tablet, orally, once daily for up to 24 weeks
Intervention Type
Drug
Intervention Name(s)
Lansoprazole 15 mg
Intervention Description
Lansoprazole 15 mg capsule, orally, once daily for up to 24 weeks
Intervention Type
Drug
Intervention Name(s)
Lansoprazole 15 mg Placebo
Intervention Description
Lansoprazole 15 mg Placebo capsule, orally, once daily for up to 24 weeks
Primary Outcome Measure Information:
Title
Proportion (%) of subjects with remission maintained on esophagogastroduodenoscopy by Week 24
Time Frame
at 24 week
Secondary Outcome Measure Information:
Title
Proportion (%) of subjects with remission maintained on esophagogastroduodenoscopy by Week 12
Time Frame
at 12 week
Other Pre-specified Outcome Measures:
Title
GERD-Health related quality life(HRQL)
Description
Changes from baseline in the total score of GERD-HRQL at Weeks 4, 12, and 24(The total score could range from 0 to 50 and lower score was evaluated as higher quality of life)
Time Frame
at Weeks 4, 12, and 24
Title
Assessment on symptoms
Description
Proportions of subjects without the major symptoms (heartburn and/or acid regurgitation) at Weeks 4, 12, and 24
Time Frame
Weeks 4, 12, and 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and female adults aged 19 to 75 years, at the date the written informed consent form is signed
Subjects with erosive esophagitis (LA Grade A-D) confirmed on EGD within 12 weeks from Visit 2 (randomization day)
Subjects with healed erosive esophagitis (no mucosal break observed according to LA classification) confirmed on EGD performed within 10 days before Visit 2 (randomization day) after receiving the standard dose of medicinal products of erosive esophagitis (PPI, P-CAB, etc.) for 4 to 8 weeks for the treatment of erosive esophagitis
Exclusion Criteria:
Subjects who have Barrett's esophagus (> 3 cm), gastroesophageal varix, esophagostenosis, ulcer stenosis, active peptic ulcer, acute gastrointestinal bleeding, or a malignant tumor upon EGD screening
Subjects who have inflammatory bowel disease (Crohn disease, ulcerative colitis, etc.), irritable bowel syndrome (IBS), primary esophageal motility, or pancreatitis.
Subjects with history of clinically significant disease of hepatic, renal, nervous, pulmonary, endocrine, hemato-oncologic, cardiovascular or urinary system
Subjects who have had a malignant tumor in the last 5 years
Subjects who must continue to take non-steroidal anti-inflammatory drugs (aspirin, etc.), antithrombotic drugs, etc. during the study period (A low dose of aspirin [100 mg/day] which has been administered for prophylactic purpose before study entry is allowed)
Subjects who cannot stop the existing erosive esophagitis treatment being taken
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Oh-Young Lee
Phone
82-2-2290-8637
Email
leeoy@hanyang.ac.kr
Facility Information:
Facility Name
The Catholic University of Korea, Yeouido ST. Mary's Hospital
City
Seoul
ZIP/Postal Code
07345
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JINIL KIM, M.D., Ph.D.
12. IPD Sharing Statement
Learn more about this trial
Study to Evaluate the Efficacy and Safety of DWP14012 on Maintaining Healing in Subjects With Healed Erosive Esophagitis
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