Study to Evaluate the Safety, Efficacy of Tegoprazan for the Prevention of PUD in Patients on Treatment With NSAIDs

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

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.

Study Overview

• Status: Recruiting
• Conditions: Preventive Peptic Ulcer
• Intervention / Treatment: Drug: Tegoprazan 25 mg; Drug: Lansoprazole 15 mg

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).

• Study Type: Interventional
• Enrollment (Estimated): 390
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Yugyeong Park; Phone Number: 82-2-6477-0269; Email: yugyeong.park@inno-n.com
• Study Contact Backup: Name: Jiwon Lee; Phone Number: 82-2-6477-0273; Email: jiwon.lee@inno-n.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Samsung Medical Center
    • Principal Investigator: Jae J. Kim
  • Seoul, Korea, Republic of
    • Recruiting
    • The catholic univ. of Korea Eunpyeong ST. Mari's hospital
    • Contact: JH Oh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tegoprazan 25mg; Tegoprazan 25mg tablets will be orally administered once a day, with NSAIDs, for up to 6 months.	Drug: Tegoprazan 25 mg; Tegoprazan 25 mg tablets will be orally administered once a day, with NSAIDs, for up to 6 months.
Active Comparator: Lansoprazole 15mg; Lansoprazole 15mg capsules will be orally administered, once a day, with NSAIDs, for up to 6 months.	Drug: Lansoprazole 15 mg; Lansoprazole 15 mg tablets will be orally administered once a day, with NSAIDs, for up to 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	week 4, 12, 24

Collaborators and Investigators

• Sponsor: HK inno.N Corporation
• Investigators: Principal Investigator: Jea Jun Kim, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2021
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: April 7, 2021
• First Submitted That Met QC Criteria: April 7, 2021
• First Posted (Actual): April 12, 2021

Study Record Updates

• Last Update Posted (Actual): July 14, 2023
• Last Update Submitted That Met QC Criteria: July 13, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Intestinal Diseases; Duodenal Diseases; Peptic Ulcer; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Dexlansoprazole; Lansoprazole
• Other Study ID Numbers: IN_APA_308

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