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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1123-8356 | Registry Identifier | WHO | |
| JapicCTI-111607 | Registry Identifier | JapicCTI |
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The purpose of this study is to determine the efficacy of TAK-438, once daily (QD), compared to lansoprazole in patients with erosive esophagitis of Grade A to D as defined by the LA classification grading system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAK-438 20 mg QD | Experimental |
| |
| AG-1749 30 mg QD | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAK-438 | Drug | TAK-438 20 mg, tablets, orally, once daily for up to 8 weeks. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Endoscopic Healing Rate Over 8 Weeks of Erosive Esophagitis | Endoscopic healing of erosive esophagitis is defined as those participants who have endoscopically confirmed EE of Grade O as defined by the Los Angeles (LA) Classification Grading System. The definitions of each grade are: Grade O (No mucosal break), Grade A (Mucosal break <5 mm), Grade B (Mucosal break ≥5 mm), Grade C (Mucosal break continuous between two or more folds and <75% of the circumference) and Grade D (Mucosal break ≥75% of the circumference). | 8 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Endoscopic Healing Rate Over 2 Weeks of Erosive Esophagitis | 2 Weeks | |
| Endoscopic Healing Rate Over 4 Weeks of Erosive Esophagitis | 4 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Senior Manager | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nagoya | Aichi-ken | Japan | ||||
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| Placebo |
| Drug |
Lansoprazole placebo-matching capsules, orally, once daily for up to 8 weeks. For participants whose EE is not endoscopically healed at Week 8, the participants will receive additional treatment of TAK-438 40 mg, tablets, orally, once daily for up to an additional 8 weeks. |
|
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| Lansoprazole | Drug | Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks. For participants whose EE is not endoscopically healed at Week 8, the participants will receive additional treatment of TAK-438 40 mg, tablets, orally, once daily for up to an additional 8 weeks. |
|
|
| Placebo | Drug | TAK-438 placebo-matching tablets, orally, once daily for up to 8 weeks. |
|
| Abiko-shi |
| Chiba |
| Japan |
| Fukuoka | Fukuoka | Japan |
| Itoshima-shi | Fukuoka | Japan |
| Kurume-shi | Fukuoka | Japan |
| Onga-gun | Fukuoka | Japan |
| Gifu | Gifu | Japan |
| Annaka-shi | Gunma | Japan |
| Aki-gun | Hiroshima | Japan |
| Hiroshima | Hiroshima | Japan |
| Sapporo | Hokkaido | Japan |
| Amagasaki-shi | Hyōgo | Japan |
| Kobe | Hyōgo | Japan |
| Takarazuka-shi | Hyōgo | Japan |
| Sakade-shi | Kagawa-ken | Japan |
| Yokohama | Kanagawa | Japan |
| Kochi | Kochi | Japan |
| Susaki-shi | Kochi | Japan |
| Kumamoto | Kumamoto | Japan |
| Kyoto | Kyoto | Japan |
| Nagasaki | Nagasaki | Japan |
| Ōita | Oita Prefecture | Japan |
| Okayama | Okayama-ken | Japan |
| Fuziidera-shi | Osaka | Japan |
| Shizuoka | Shizuoka | Japan |
| Otawara-shi | Tochigi | Japan |
| Chiyoda-ku | Tokyo | Japan |
| Chuo-ku | Tokyo | Japan |
| Nakano-ku | Tokyo | Japan |
| Ōta-ku | Tokyo | Japan |
| Setagaya-ku | Tokyo | Japan |
| Yamagata | Yamagata | Japan |
| ID | Term |
|---|---|
| C552956 | 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine |
| D064747 | Lansoprazole |
| 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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