Back to resultsStudy to Evaluate the Safety, Efficacy of Tegoprazan for the Prevention of PUD in Patients on Treatment With NSAIDs
Primary Purpose
Preventive Peptic Ulcer
Status
Recruiting
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Lansoprazole 15 mg
Tegoprazan 25 mg
Sponsored by
About this trial
This is an interventional prevention trial for Preventive Peptic Ulcer
Eligibility Criteria
Inclusion Criteria:
- ≥60 years of age, or ≥20 years of age with a history of gastroduodenal ulcers (gastric and/or duodenal ulcers) at screening
- Requires continued treatment with NSAIDs for ≥24 weeks
Exclusion Criteria:
- Has an active stage (A1, A2) or healing stage (H1, H2) of gastroduodenal ulcers per the Sakita-Miwa classification identified by upper GI endoscopy at screening
- Has uncontrolled severe hypertension
- Has severe heart failure, congestive heart failure (NYHA Ⅱ to Ⅳ), ischemic heart disease (unstable angina, myocardial infarction), or peripheral artery disease, or has undergone coronary artery bypass graft (CABG) who is considered ineligible for treatment with NSAIDs
- Has a positive H. pylori test at screening
Sites / Locations
- Samsung Medical CenterRecruiting
- The catholic univ. of Korea Eunpyeong ST. Mari's hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Tegoprazan 25mg
Lansoprazole 15mg
Arm Description
Tegoprazan 25mg tablets will be orally administered once a day, with NSAIDs, for up to 6 months.
Lansoprazole 15mg capsules will be orally administered, once a day, with NSAIDs, for up to 6 months.
Outcomes
Primary Outcome Measures
Proportion of subjects with gastric and/or duodenal ulcers at Week 24
The proportion of subjects with gastric and/or duodenal ulcers on upper GI endoscopy at Week 24
Secondary Outcome Measures
Proportion of subjects without NSAID-related GI symptoms at Weeks 4, 12, and 24
GI symptoms are as follows; Heartburn, Regurgitation, Upper abdominal pain or discomfort
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04840550
Brief Title
Study to Evaluate the Safety, Efficacy of Tegoprazan for the Prevention of PUD in Patients on Treatment With NSAIDs
Official Title
A Phase 3, Randomized, Double-blind, Active-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Tegoprazan 25 mg for the Prevention of Peptic Ulcer Disease in Patients on Continuous Long-term Treatment With NSAIDs
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 7, 2021 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HK inno.N Corporation
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 is designed to confirm the non-inferiority of Tegoprazan 25 mg, compared to Lansoprazole 15 mg, to prevent gastroduodenal ulcers and verify the safety of tegoprazan following oral administration of tegoprazan 25 mg QD or lansoprazole 15 mg QD in patients on long-term treatment with NSAIDs.
Detailed Description
This is a double-blind, randomized, active-controlled, phase 3 study. Subjects will be randomly assigned to one of the two treatment groups (tegoprazan 25 mg, lansoprazole 15 mg).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preventive Peptic Ulcer
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
390 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tegoprazan 25mg
Arm Type
Experimental
Arm Description
Tegoprazan 25mg tablets will be orally administered once a day, with NSAIDs, for up to 6 months.
Arm Title
Lansoprazole 15mg
Arm Type
Active Comparator
Arm Description
Lansoprazole 15mg capsules will be orally administered, once a day, with NSAIDs, for up to 6 months.
Intervention Type
Drug
Intervention Name(s)
Lansoprazole 15 mg
Intervention Description
Lansoprazole 15 mg tablets will be orally administered once a day, with NSAIDs, for up to 6 months.
Intervention Type
Drug
Intervention Name(s)
Tegoprazan 25 mg
Intervention Description
Tegoprazan 25 mg tablets will be orally administered once a day, with NSAIDs, for up to 6 months.
Primary Outcome Measure Information:
Title
Proportion of subjects with gastric and/or duodenal ulcers at Week 24
Description
The proportion of subjects with gastric and/or duodenal ulcers on upper GI endoscopy at Week 24
Time Frame
week 24
Secondary Outcome Measure Information:
Title
Proportion of subjects without NSAID-related GI symptoms at Weeks 4, 12, and 24
Description
GI symptoms are as follows; Heartburn, Regurgitation, Upper abdominal pain or discomfort
Time Frame
week 4, 12, 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
≥60 years of age, or ≥20 years of age with a history of gastroduodenal ulcers (gastric and/or duodenal ulcers) at screening
Requires continued treatment with NSAIDs for ≥24 weeks
Exclusion Criteria:
Has an active stage (A1, A2) or healing stage (H1, H2) of gastroduodenal ulcers per the Sakita-Miwa classification identified by upper GI endoscopy at screening
Has uncontrolled severe hypertension
Has severe heart failure, congestive heart failure (NYHA Ⅱ to Ⅳ), ischemic heart disease (unstable angina, myocardial infarction), or peripheral artery disease, or has undergone coronary artery bypass graft (CABG) who is considered ineligible for treatment with NSAIDs
Has a positive H. pylori test at screening
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yugyeong Park
Phone
82-2-6477-0269
Email
yugyeong.park@inno-n.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jiwon Lee
Phone
82-2-6477-0273
Email
jiwon.lee@inno-n.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jea Jun Kim
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae J. Kim
Facility Name
The catholic univ. of Korea Eunpyeong ST. Mari's hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JH Oh
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study to Evaluate the Safety, Efficacy of Tegoprazan for the Prevention of PUD in Patients on Treatment With NSAIDs
We'll reach out to this number within 24 hrs