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The objective of this clinical trial is to compare which of the two drugs best resolves symptoms in patients diagnosed with erosive and non-erosive gastroesophageal reflux disease, adult males and females. The main question is What is the proportion of patients with resolution of the main symptoms of gastroesophageal reflux disease at four weeks of treatment with pantoprazole vs tegoprazan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-erosive GERD - Test product | Experimental | Non-erosive GERD - Tegoprazan |
|
| Non-erosive GERD - Comparator | Active Comparator | Non-erosive GERD - Pantoprazole |
|
| Erosive GERD - Test product | Experimental | Erosive GERD - Tegoprazan |
|
| Erosive GERD - Comparator | Active Comparator | Erosive GERD - Pantoprazol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tegoprazan | Drug | Tegoprazan 50 mg daily for 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with resolution of the main symptoms of gastroesophageal reflux disease | Carlsson-Dent Questionnaire. These tool consists of 7 multiple-choice questions, using a cut-off point ≥ 4 to be considered positive, which qualitatively assesses symptoms associated with GERD and triggering factors such as diet, posture and medications used. | From enrollment to the end of treatment at 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jose M Remes-Troche, Dr | Digestive Physiology and Motility Lab, Instituto de Investigaciones Médico Biológicas, Veracruz , México | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gastrologen S.A. de C.V. | Recruiting | Mexico City | Mexico City | 01900 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36314172 | Background | Cho YK, Kim JH, Kim HS, Kim TO, Oh JH, Choi SC, Moon JS, Lee SK, Jung SW, Kim SS, Jung HK, Lee SP, Cheon GJ, Park MI, Jung HY, Ko KH, Sung IK, Lee SH, Lee JY, Lee ST, Rhee PL, Kim N, Hong SJ, Kim HJ, Kim GH, Lee KJ, Kim SK, Shin WG, Lee OY. Randomised clinical trial: comparison of tegoprazan and lansoprazole as maintenance therapy for healed mild erosive oesophagitis. Aliment Pharmacol Ther. 2023 Jan;57(1):72-80. doi: 10.1111/apt.17255. Epub 2022 Oct 31. |
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Only IPD used in the results publication
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| Pantoprazole | Drug | Pantoprazole 40 mg daily for 28 days |
|
| Saluz Investigación, S.C. | Recruiting | Boca del RÃo | Veracruz | 94299 | Mexico |
|
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000631239 | tegoprazan |
| D000077402 | Pantoprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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