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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1125-1054 | Registry Identifier | WHO | |
| JapicCTI-111662 | Registry Identifier | JapicCTI |
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The purpose of this study is to confirm the efficacy of TAK-438, once daily (QD), compared to lansoprazole for the maintenance treatment of healed erosive esophagitis and to determine the clinical dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAK-438 10 mg QD | Experimental |
| |
| TAK-438 20 mg QD | Experimental |
| |
| Lansoprazole 15 mg QD | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAK-438 | Drug | In the treatment period, the participants will receive treatment of TAK-438 20 mg, tablets, orally, once daily for up to 8 weeks. In the maintenance treatment period, the participants will receive treatment of TAK-438 10 mg, tablets, orally, once daily and lansoprazole placebo-matching capsules, orally, once daily for up to 24 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Endoscopically confirmed recurrence rate of erosive esophagitis after 24 weeks of maintenance treatment | Endoscopic recurrence of erosive esophagitis is defined as those participants who have endoscopically confirmed EE of Grade A to D 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). | 24 Weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Endoscopically confirmed recurrence rate of erosive esophagitis after 12 weeks of maintenance treatment | 12 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 |
|---|---|---|---|---|---|---|
| Kashiwa-shi | Chiba | Japan | ||||
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|
| TAK-438 | Drug | In the treatment period, the participants will receive treatment of TAK-438 20 mg, tablets, orally, once daily for up to 8 weeks. In the maintenance treatment period, the participants will receive treatment of TAK-438 20 mg, tablets, orally, once daily and lansoprazole placebo-matching capsules, orally, once daily for up to 24 weeks. |
|
| Lansoprazole | Drug | In the treatment period, the participants will receive treatment of TAK-438 20 mg, tablets, orally, once daily for up to 8 weeks. In the maintenance treatment period, the participants will receive treatment of TAK-438 placebo-matching tablets, orally, once daily and lansoprazole 15 mg, capsules, orally, once daily for up to 24 weeks. |
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|
| Yachiyo-shi |
| Chiba |
| Japan |
| Saijo-shi | Ehime | Japan |
| Fukuoka | Fukuoka | Japan |
| Kasuya-gun | Fukuoka | Japan |
| Koriyama-shi | Fukushima | Japan |
| Takayama-shi | Gifu | Japan |
| Annaka-shi | Gunma | Japan |
| Asahikawa-shi | Hokkaido | Japan |
| Sapporo | Hokkaido | Japan |
| Itami-shi | Hyōgo | Japan |
| Kobe | Hyōgo | Japan |
| Nishinomiya-shi | Hyōgo | Japan |
| Fujisawa-shi | Kanagawa | Japan |
| Yokohama | Kanagawa | Japan |
| Kochi | Kochi | Japan |
| Kumamoto | Kumamoto | Japan |
| Kyoto | Kyoto | Japan |
| Sendai | Miyagi | Japan |
| Nagasaki | Nagasaki | Japan |
| Kishiwada-shi | Osaka | Japan |
| Osaka | Osaka | Japan |
| Suita-shi | Osaka | Japan |
| Takatsuki-shi | Osaka | Japan |
| Saga | Saga-ken | Japan |
| Kumagaya-shi | Saitama | Japan |
| Saitama-shi | Saitama | Japan |
| Tokorozawa-shi | Saitama | Japan |
| Bunkyo-ku | Tokyo | Japan |
| Chuo-ku | Tokyo | Japan |
| Hachioji-shi | Tokyo | Japan |
| Kokubunji-shi | Tokyo | Japan |
| Shibuya-ku | Tokyo | Japan |
| Shinjuku-ku | Tokyo | Japan |
| Toshima-ku | Tokyo | Japan |
| Shimonoseki-shi | Yamaguchi | Japan |
| Tsuru-shi | Yamanashi | 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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