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This study is designed to evaluate the efficacy and safety of Tegoprazan 50mg, compared to Lansoprazole 30mg in patients with healed erosive reflux disease confirmed by endoscopy following oral administration once daily(QD) of 2 weeks or 4 weeks.
This is a double blind, radomized, active-controlled, phase 4 study. Subjects will be randomly assigned to one of the two treatment groups (Tegoprazan 50mg, Lansoprazole 30mg)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tegoprazan 50mg QD | Experimental | Tegoprazan 50mg tablet, once daily, oral administration |
|
| Lansoprazole 30mg QD | Active Comparator | Lansoprazole 30mg capsule, once dauly, oral administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tegoprazan 50mg QD | Drug | Tegoprazan 50mg tablets will be orally administered, once daily, for up to 2 weeks or 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 4 weeks cumulative ERD healing rate(%) | Healing is defined as "not present" erosions or fissures according to the LA classification. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 2 weeks ERD healing rate(%) | Healing is defined as "not present" erosions or fissures according to the LA classification. | 2 weeks |
| Healing rate(%) at 2 weeks and 4 weeks according to CYP2C19 genotype type |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suk Chae Choi | Wonkwang University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wonkwang University Hospital | Iksan | Muwang-ro 895 | 54538 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39587796 | Derived | Shin CM, Choi SC, Cho JW, Kim SY, Lee OJ, Kim DH, Cho YK, Lee JY, Lee SK, Shin JE, Kim GH, Park SY, Hong SJ, Jung HK, Lee SJ, Youn YH, Jeon SW, Sung IK, Park MI, Lee OY. Comparison of Tegoprazan and Lansoprazole in Patients With Erosive Esophagitis up to 4 Weeks: A Multi-Center, Randomized, Double-Blind, Active-Comparator Phase 4 Trial. Neurogastroenterol Motil. 2025 Jan;37(1):e14969. doi: 10.1111/nmo.14969. Epub 2024 Nov 25. |
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| ID | Term |
|---|---|
| C000631239 | tegoprazan |
| D064747 | Lansoprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Lansoprazole 30mg QD | Drug | Lansoprazole 30mg tablets will be orally administered, once daily, for up to 2 weeks or 4 weeks. |
|
Extensive Metaboliser (EM), Intermediate Metaboliser (IM), Poor Metaboliser (PM)
| 2 weeks or 4 weeks |
| Percentage of days without heartburn through the clinical trial subject dairy (%) | On days with no symptoms of heartburn, '0. It is defined as a case assessed as having no symptoms. | 2 weeks or 4 weeks |
| RDQ (Reflux Disease Questionnaire) evaluation(mean change in severity) | Average scale change in RDQ severity and frequency at 2 weeks and 4 weeks after administration compared to before administration of investigational drugs for each category (heartburn, indigestion, acid reflux) | 2 weeks or 4 weeks |
| Incidence of Adverse Events [Safety] | Physical examination(weight-kg)(height-cm), vital signs(SBP, DBP, heart rate, body temperature), adverse reactions, blood chemistry test | 2 weeks or 4 weeks |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |