Back to resultsStudy to Evaluate the Efficacy and Safety of DWP14012 in Prevention of NSAIDs Induced Peptic Ulcer
Primary Purpose
Peptic Ulcer
Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
DWP14012 20mg
Lansoprazole 15 mg
DWP14012 20mg placebo
Lansoprazole 15 mg placebo
Sponsored by
About this trial
This is an interventional prevention trial for Peptic Ulcer
Eligibility Criteria
Inclusion Criteria:
- Male and female adults aged ≥ 19 years at the time of informed consent
- Subjects who are diagnosed with musculoskeletal disease at screening and require continued treatment with NSAIDs for at least 24 weeks
- Subjects with at least one of the following risk factors for ulcer development at screening.
- Subjects who have no gastric or duodenal mucosal break or have ulcer in the scarring stage based on the EGD result at screening.
Exclusion Criteria:
- Subjects with esophagitis, gastroesophageal varix, esophagus, Barrett's esophagus, acute gastrointestinal bleeding and else based on the screening EGD results.
- Subjects who have undergone gastroduodenal surgery or total small bowel resection
- 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 history of hypersensitivity to the IP ingredients, aspirin and NSAIDs
Sites / Locations
- Asan Medical Center
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 who develop peptic ulcer by Week 24 as assessed by investigator
Secondary Outcome Measures
Proportion of subjects who develop peptic ulcer by Week 12 as assessed by investigator
Proportion of subjects with endoscopic gastric or duodenal bleeding** by Week 12 and Week 24
Full Information
NCT ID
NCT04784910
First Posted
March 3, 2021
Last Updated
March 4, 2021
Sponsor
Daewoong Pharmaceutical Co. LTD.
1. Study Identification
Unique Protocol Identification Number
NCT04784910
Brief Title
Study to Evaluate the Efficacy and Safety of DWP14012 in Prevention of NSAIDs Induced Peptic Ulcer
Official Title
A Multi-center, Randomized, Double-blind, Parallel-group, Active-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DWP14012 in Prevention of NSAIDs Induced Peptic Ulcer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 2021 (Anticipated)
Primary Completion Date
July 31, 2021 (Anticipated)
Study Completion Date
February 28, 2022 (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
The study aims to demonstrate the preventive effect of DWP14012 20 mg for peptic ulcer is non-inferior to that of Lansoprazole 15 mg in terms of prevention of peptic ulcer and confirm the safety of DWP14012 20 mg.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peptic Ulcer
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
416 (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 20mg
Intervention Description
DWP14012 20mg, tablet, orally, once daily for up to 24 weeks
Intervention Type
Drug
Intervention Name(s)
Lansoprazole 15 mg
Intervention Description
Lansoprazole 15mg capsule, orally, once daily for up to 24 weeks
Intervention Type
Drug
Intervention Name(s)
DWP14012 20mg placebo
Intervention Description
DWP14012 20mg placebo-matching tablet, orally, once daily for up to 24 weeks
Intervention Type
Drug
Intervention Name(s)
Lansoprazole 15 mg placebo
Intervention Description
Lansoprazole 15mg placebo matching capsule, orally, once daily for up to 24 weeks
Primary Outcome Measure Information:
Title
Proportion of subjects who develop peptic ulcer by Week 24 as assessed by investigator
Time Frame
at 24 weeks
Secondary Outcome Measure Information:
Title
Proportion of subjects who develop peptic ulcer by Week 12 as assessed by investigator
Time Frame
at 12 weeks
Title
Proportion of subjects with endoscopic gastric or duodenal bleeding** by Week 12 and Week 24
Time Frame
at 12, 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and female adults aged ≥ 19 years at the time of informed consent
Subjects who are diagnosed with musculoskeletal disease at screening and require continued treatment with NSAIDs for at least 24 weeks
Subjects with at least one of the following risk factors for ulcer development at screening.
Subjects who have no gastric or duodenal mucosal break or have ulcer in the scarring stage based on the EGD result at screening.
Exclusion Criteria:
Subjects with esophagitis, gastroesophageal varix, esophagus, Barrett's esophagus, acute gastrointestinal bleeding and else based on the screening EGD results.
Subjects who have undergone gastroduodenal surgery or total small bowel resection
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 history of hypersensitivity to the IP ingredients, aspirin and NSAIDs
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ChangKeun Lee, M.D, Ph.D.
Phone
02-3010-3284
Email
cklee@amc.seoul.kr
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Study to Evaluate the Efficacy and Safety of DWP14012 in Prevention of NSAIDs Induced Peptic Ulcer
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