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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1123-8762 | Registry Identifier | WHO | |
| JapicCTI-111611 | Registry Identifier | JapicCTI |
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The purpose of this study is to evaluate the safety of TAK-438, once daily (QD), during long-term concomitant non-steroidal anti-inflammatory drug (NSAID) therapy in patients with a history of gastric or duodenal ulcer who require long-term therapy of NSAID.
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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 | TAK-438 10 mg tablets, orally, once daily for 28-80 weeks. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events | Treatment-emergent adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through the last visit of study. | Up to 80 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Laboratory values | Up to 80 weeks. | |
| Change from baseline in Electrocardiograms | Up to 80 weeks. | |
| Change from baseline in Vital signs |
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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 |
|---|---|---|---|---|---|---|
| Kasugai-shi | Aichi-ken | Japan | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28988197 | Derived | Mizokami Y, Oda K, Funao N, Nishimura A, Soen S, Kawai T, Ashida K, Sugano K. Vonoprazan prevents ulcer recurrence during long-term NSAID therapy: randomised, lansoprazole-controlled non-inferiority and single-blind extension study. Gut. 2018 Jun;67(6):1042-1051. doi: 10.1136/gutjnl-2017-314010. Epub 2017 Oct 7. |
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| Placebo |
| Drug |
Lansoprazole placebo matching capsules, orally, once daily for 28-80 weeks. |
|
| TAK-438 | Drug | TAK-438 20 mg tablets, orally, once daily for 28-80 weeks. |
|
| Placebo | Drug | Lansoprazole placebo-matching capsules, orally, once daily for 28-80 weeks. |
|
| Lansoprazole | Drug | Lansoprazole 15 mg capsules, orally, once daily for 28-80 weeks. |
|
|
| Placebo | Drug | TAK-438 placebo-matching tablets, orally, once daily for 28-80 weeks. |
|
| Up to 80 weeks. |
| Change from baseline in Serum gastrin | Up to 80 weeks. |
| Change from baseline in Pepsinogen I and II | Up to 80 weeks. |
| Recurrence rate of gastric or duodenal ulcer | Up to 80 weeks. |
| Nagoya |
| Aichi-ken |
| Japan |
| Seto-shi | Aichi-ken | Japan |
| Akita | Akita | Japan |
| Funabashi-shi | Chiba | Japan |
| Ichihara-shi | Chiba | Japan |
| Nagareyama-shi | Chiba | Japan |
| Matsuyama | Ehime | Japan |
| Niihama-shi | Ehime | Japan |
| Saijo-shi | Ehime | Japan |
| Fukui-shi | Fukui | Japan |
| Fukuoka | Fukuoka | Japan |
| Itoshima-shi | Fukuoka | Japan |
| Kitakyusyu-shi | Fukuoka | Japan |
| Munakata-shi | Fukuoka | Japan |
| Onga-gun | Fukuoka | Japan |
| Tagawa-shi | Fukuoka | Japan |
| Yukuhashi-shi | Fukuoka | Japan |
| Fukushima | Fukushima | Japan |
| Koriyama-shi | Fukushima | Japan |
| Mebashi-shi | Gunma | Japan |
| Takasaki-shi | Gunma | Japan |
| Fukuyama-shi | Hiroshima | Japan |
| Hatsukaichi-shi | Hiroshima | Japan |
| Higashihirosima-shi | Hiroshima | Japan |
| Asahikawa-shi | Hokkaido | Japan |
| Hakodate-shi | Hokkaido | Japan |
| Obihiro-shi | Hokkaido | Japan |
| Sapporo | Hokkaido | Japan |
| Sunagawa-shi | Hokkaido | Japan |
| Tomakomai-shi | Hokkaido | Japan |
| Akashi-shi | Hyōgo | Japan |
| Himeji-shi | Hyōgo | Japan |
| Itami-shi | Hyōgo | Japan |
| Kako-gun | Hyōgo | Japan |
| Kato-shi | Hyōgo | Japan |
| Kobe | Hyōgo | Japan |
| Nishinomiya-shi | Hyōgo | Japan |
| Higashiibaragi-gun | Ibaragi | Japan |
| Koga-shi | Ibaragi | Japan |
| Mito | Ibaragi | Japan |
| Hakusan-shi | Ishikawa-ken | Japan |
| Komatsu-shi | Ishikawa-ken | Japan |
| Takamatsu | Kagawa-ken | Japan |
| Kamakura-shi | Kanagawa | Japan |
| Kawasaki-shi | Kanagawa | Japan |
| Sagamihara-shi | Kanagawa | Japan |
| Yokohama | Kanagawa | Japan |
| Kochi | Kochi | Japan |
| Kumamoto | Kumamoto | Japan |
| Uji-shi | Kyoto | Japan |
| Tsu | Mie-ken | Japan |
| Sendai | Miyagi | Japan |
| Matsumoto-shi | Nagano | Japan |
| Nagano | Nagano | Japan |
| Nagasaki | Nagasaki | Japan |
| Ikoma-shi | Nara | Japan |
| Nara | Nara | Japan |
| Nigata-shi | Niigata | Japan |
| Beppu-shi | Oita Prefecture | Japan |
| Ōita | Oita Prefecture | Japan |
| Yuhu-shi | Oita Prefecture | Japan |
| Kurashiki-shi | Okayama-ken | Japan |
| Higashiosaka-shi | Osaka | Japan |
| Moriguchi-shi | Osaka | Japan |
| Osaka | Osaka | Japan |
| Osakasayama-shi | Osaka | Japan |
| Tondabayashi-shi | Osaka | Japan |
| Ogi-shi | Saga-ken | Japan |
| Ageo-shi | Saitama | Japan |
| Hiki-gun | Saitama | Japan |
| Kasukabe-shi | Saitama | Japan |
| Kumagaya-shi | Saitama | Japan |
| Saitama-shi | Saitama | Japan |
| Sayama-shi | Saitama | Japan |
| Toda-shi | Saitama | Japan |
| Tokorozawa-shi | Saitama | Japan |
| Ōtsu | Shiga | Japan |
| Hamamatsu | Shizuoka | Japan |
| Shizuoka | Shizuoka | Japan |
| Naruto-shi | Tokushima | Japan |
| Adachi-ku | Tokyo | Japan |
| Bunkyo-ku | Tokyo | Japan |
| Hachiouji-shi | Tokyo | Japan |
| Koto-ku | Tokyo | Japan |
| Meguro-ku | Tokyo | Japan |
| Minato-ku | Tokyo | Japan |
| Musashimurayama-shi | Tokyo | Japan |
| Nakano-ku | Tokyo | Japan |
| Ōta-ku | Tokyo | Japan |
| Setagaya-ku | Tokyo | Japan |
| Sumida-ku | Tokyo | Japan |
| Yonago-shi | Tottori | Japan |
| Tonami-shi | Toyama | Japan |
| Toyama | Toyama | Japan |
| Shimonoseki-shi | Yamaguchi | Japan |
| Ube-shi | Yamaguchi | Japan |
| ID | Term |
|---|---|
| D013276 | Stomach Ulcer |
| D004381 | Duodenal Ulcer |
| ID | Term |
|---|---|
| D010437 | Peptic Ulcer |
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D013272 | Stomach Diseases |
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| 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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