Preventive Peptic Ulcer Clinical Trial
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
| NCT number | NCT04840550 |
| Other study ID # | IN_APA_308 |
| Secondary ID | |
| Status | Recruiting |
| Phase | Phase 3 |
| First received | |
| Last updated | |
| Start date | May 7, 2021 |
| Est. completion date | July 2024 |
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.
| Status | Recruiting |
| Enrollment | 390 |
| Est. completion date | July 2024 |
| Est. primary completion date | June 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years and older |
| Eligibility | 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 ? to ?), 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 |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Samsung Medical Center | Seoul | |
| Korea, Republic of | The catholic univ. of Korea Eunpyeong ST. Mari's hospital | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| HK inno.N Corporation |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 |