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

NCT04840550 | Unknown Phase 3

• 1 other identifier: IN_APA_308
• Study Type: interventional
• Target: 390
• Locations: 1 country
• Sites: 2

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.

Conditions

Preventive Peptic Ulcer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Proportion of subjects without NSAID-related GI symptoms at Weeks 4, 12, and 24

  week 4, 12, 24

Study Arms (2)

Tegoprazan 25mg

EXPERIMENTAL

Tegoprazan 25mg tablets will be orally administered once a day, with NSAIDs, for up to 6 months.

Drug: Tegoprazan 25 mg

Lansoprazole 15mg

ACTIVE COMPARATOR

Lansoprazole 15mg capsules will be orally administered, once a day, with NSAIDs, for up to 6 months.

Drug: Lansoprazole 15 mg

Interventions

Lansoprazole 15 mg DRUG

Lansoprazole 15 mg tablets will be orally administered once a day, with NSAIDs, for up to 6 months.

Lansoprazole 15mg

Tegoprazan 25 mg DRUG

Tegoprazan 25 mg tablets will be orally administered once a day, with NSAIDs, for up to 6 months.

Tegoprazan 25mg

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• HK inno.N Corporation: lead

Study Sites (2)

Samsung Medical Center

Seoul, South Korea

RECRUITING

The catholic univ. of Korea Eunpyeong ST. Mari's hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Interventions

Lansoprazole; tegoprazan

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Jea Jun Kim

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yugyeong Park

CONTACT

82-2-6477-0269; yugyeong.park@inno-n.com

Jiwon Lee

CONTACT

82-2-6477-0273; jiwon.lee@inno-n.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: April 12, 2021
• Study Start: May 7, 2021
• Primary Completion: June 1, 2024
• Study Completion: July 1, 2024
• Last Updated: July 14, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)