Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1123-8648 | Registry Identifier | WHO | |
| JapicCTI-111608 | Registry Identifier | JapicCTI |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine the efficacy of TAK-438, once daily (QD), compared to lansoprazole in patients with duodenal ulcer.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAK-438 20 mg QD | Experimental |
| |
| Lansoprazole 30 mg QD | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAK-438 | Drug | TAK-438 20 mg, tablets, orally, once daily for up to 6 weeks. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Endoscopic Healing Rate of Duodenal Ulcer Over 6 Weeks | Endoscopic healing rate : Rate of participants who have endoscopically confirmed all of the white coatings disappeared. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Endoscopic healing Rates of Duodenal Ulcer on Endoscopy over 4 weeks | 4 weeks | |
| Endoscopic healing Rates of Gastric Ulcer on Endoscopy at week 2 | 2 weeks | |
| Change from Baseline in the Incidence of Gastrointestinal Symptoms Associated with Duodenal Ulcer |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Senior Manager | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toyota-shi | Aichi-ken | Japan | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27891632 | Derived | Miwa H, Uedo N, Watari J, Mori Y, Sakurai Y, Takanami Y, Nishimura A, Tatsumi T, Sakaki N. Randomised clinical trial: efficacy and safety of vonoprazan vs. lansoprazole in patients with gastric or duodenal ulcers - results from two phase 3, non-inferiority randomised controlled trials. Aliment Pharmacol Ther. 2017 Jan;45(2):240-252. doi: 10.1111/apt.13876. Epub 2016 Nov 27. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
Lansoprazole placebo-matching capsules, orally, once daily for up to 6 weeks. |
|
| Lansoprazole | Drug | Lansoprazole 30 mg, capsules, orally, once daily for up to 6 weeks. |
|
|
| Placebo | Drug | TAK-438 placebo-matching tablets, orally, once daily for up to 6 weeks. |
|
| Baseline and 6 weeks |
| Kamagaya-shi |
| Chiba |
| Japan |
| Kisarazu-shi | Chiba | Japan |
| Fukui-shi | Fukui | Japan |
| Fukuoka | Fukuoka | Japan |
| Kitakyushu-shi | Fukuoka | Japan |
| Kurume-shi | Fukuoka | Japan |
| Onga-gun | Fukuoka | Japan |
| Tagawa-shi | Fukuoka | Japan |
| Yanagawa-shi | Fukuoka | Japan |
| Yukuhashi-shi | Fukuoka | Japan |
| Sappori-shi | Hokkaido | Japan |
| Kobe | Hyōgo | Japan |
| Nishinomiya-shi | Hyōgo | Japan |
| Takarazuka-shi | Hyōgo | Japan |
| Hitachi-shi | Ibaraki | Japan |
| Hitacinaka-shi | Ibaraki | Japan |
| Marugame-shi | Kagawa-ken | Japan |
| Takamatsu | Kagawa-ken | Japan |
| Kagoshima | Kagoshima-ken | Japan |
| Kanoya-shi | Kagoshima-ken | Japan |
| Kawasaki-shi | Kanagawa | Japan |
| Yokohama | Kanagawa | Japan |
| Kumamoto | Kumamoto | Japan |
| Yashiro-shi | Kumamoto | Japan |
| Kyoto | Kyoto | Japan |
| Nagasaki | Nagasaki | Japan |
| Sasebo-shi | Nagasaki | Japan |
| Ōita | Oita Prefecture | Japan |
| Okayama | Okayama-ken | Japan |
| Shimajiri-gun | Okinawa | Japan |
| Daito-shi | Osaka | Japan |
| Fujiidera-shi | Osaka | Japan |
| Hirakata-shi | Osaka | Japan |
| Kishiwada-shi | Osaka | Japan |
| Osaka | Osaka | Japan |
| Sakai-shi | Osaka | Japan |
| Suita-shi | Osaka | Japan |
| Takatsuki-shi | Osaka | Japan |
| Toyonaka-shi | Osaka | Japan |
| Saga | Saga-ken | Japan |
| Ageo-shi | Saitama | Japan |
| Kumagaya-shi | Saitama | Japan |
| Tokorozawa-shi | Saitama | Japan |
| Ōtsu | Shiga | Japan |
| Shizuoka | Shizuoka | Japan |
| Ashikaga-shi | Tochigi | Japan |
| Otawara-shi | Tochigi | Japan |
| Shimotsuga-gun | Tochigi | Japan |
| Shimotsuke-shi | Tochigi | Japan |
| Tokushima | Tokushima | Japan |
| Hachioji-shi | Tokyo | Japan |
| Kodaira-shi | Tokyo | Japan |
| Kokubunji-shi | Tokyo | Japan |
| Meguro-ku | Tokyo | Japan |
| Minato-ku | Tokyo | Japan |
| Mitaka-shi | Tokyo | Japan |
| Ōta-ku | Tokyo | Japan |
| Setagaya-ku | Tokyo | Japan |
| Shinagawa-ku | Tokyo | Japan |
| Wakayama | Wakayama | Japan |
| Yamagata | Yamagata | Japan |
| Shimonoseki-shi | Yamaguchi | Japan |
| Kofu | Yamanashi | Japan |
| ID | Term |
|---|---|
| D004381 | Duodenal Ulcer |
| ID | Term |
|---|---|
| D010437 | Peptic Ulcer |
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D013272 | Stomach Diseases |
Not provided
Not provided
| 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 |
Not provided
Not provided