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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1123-9677 | Registry Identifier | WHO | |
| JapicCTI-111615 | Registry Identifier | JapicCTI |
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The purpose of this study is to determine the safety of long term use of TAK-438, once daily (QD), for the maintenance treatment of healed erosive esophagitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAK-438 10 mg QD | Experimental |
| |
| TAK-438 20 mg QD | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAK-438 | Drug | TAK-438 10 mg, tablets, orally, once daily for up to 52 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. | 52 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Laboratory Values | Baseline and Week 52 | |
| Change from Baseline in Electrocardiograms | Baseline and Week 52 | |
| Change from Baseline in Vital Signs |
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Inclusion Criteria:
Participants must have successfully completed the preceding phase 3 double-blind study (TAK-438/CCT-002: preceding study) and have endoscopically healed EE at Week 2, 4, or 8 in the preceding study.*
* "Endoscopically healed EE" is defined as those participants who have endoscopically confirmed EE of Grade O as defined by the Los Angeles (LA) Classification Grading System.
Outpatient (including inpatient for examination)
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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| TAK-438 |
| Drug |
TAK-438 20 mg, tablets, orally, once daily for up to 52 weeks. |
|
| Baseline and Week 52 |
| Change from Baseline in Serum Gastrin | Baseline and Week 52 |
| Change from Baseline in Pepsinogen I and II | Baseline and Week 52 |
| Endoscopically confirmed recurrence rate of Erosive Esophagitis | 52 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 |
| Sakaide-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 |
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