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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1125-1115 | Registry Identifier | WHO | |
| JapicCTI-111663 | Registry Identifier | JapicCTI |
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The purpose of this study is to investigate the superiority of efficacy of TAK-438, once daily (QD), to placebo in patients with non-erosive gastroesophageal reflux disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAK-438 10 mg QD | Experimental |
| |
| TAK-438 20 mg QD | Experimental |
| |
| Placebo QD | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAK-438 | Drug | TAK-438 10 mg, tablets, orally, once daily for 4 weeks. Thereafter, TAK-438 placebo tablets, orally, once daily for 1 week. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of symptom-free days of heartburn symptoms | Heartburn symptoms will be collected by participant diaries. | Week 4 |
| Cumulative symptom improvement rate of heartburn symptoms | Heartburn symptoms will be collected by participant diaries. | Week 4 |
| Severity of heartburn symptoms | Heartburn symptoms will be collected by participant diaries. | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Heartburn symptoms stratified by response (improvement or non-improvement) at Week 2 | Heartburn symptoms will be collected by participant diaries. Percentage of symptom-free days, cumulative symptom improvement rate, and severity of heartburn symptoms are evaluation parameters. | Week 4 |
| Heartburn Symptoms Stratified by Baseline Endoscopic Findings (Grade N or M) |
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Inclusion Criteria:
Participants with grade N or M in the modified LA classification system confirmed by endoscopy at initiation of the pre-observation period (VISIT 1).
Participants with repeated acid reflux symptoms (heartburn or regurgitation) for 2 days or more in one week in the 3 weeks before initiation of initiation of the pre-observation period (VISIT 1).
Participants with severity* of moderate or higher for acid reflux symptoms (heartburn or regurgitation) in the 3 weeks before initiation of the pre-observation period (VISIT 1)
* Severity: No symptoms, very mild (symptoms present but often forgotten), mild (not so painful), moderate (rather painful), severe (painful) and very severe (painful enough to affect night time sleep or daily activities)
Outpatients (hospitalization for testing possible)
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 | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28119763 | Derived | Kinoshita Y, Sakurai Y, Shiino M, Kudou K, Nishimura A, Miyagi T, Iwakiri K, Umegaki E, Ashida K. Evaluation of the Efficacy and Safety of Vonoprazan in Patients with Nonerosive Gastroesophageal Reflux Disease: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study. Curr Ther Res Clin Exp. 2016 Dec 21;81-82:1-7. doi: 10.1016/j.curtheres.2016.12.001. eCollection 2016. |
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| TAK-438 | Drug | TAK-438 20 mg, tablets, orally, once daily for 4 weeks. Thereafter, TAK-438 placebo tablets, orally, once daily for 1 week. |
|
| Placebo | Drug | TAK-438 placebo-matching tablets, orally, once daily for 5 weeks. |
|
Heartburn symptoms collected by participant diaries. Percentage of symptom-free days, cumulative symptom improvement rate and severity of heartburn symptoms=evaluation parameters. Participants with Non-Erosive Gastroesophageal Reflux Disease divided into Grade N (endoscopically normal) and M (minimal change) by modified Los Angeles Classification System. Grade definitions: Grade N (endoscopically normal), M (minimal change), A (Mucosal break <5 mm) B (Mucosal break ≥5 mm) C (Mucosal break continuous between 2 or more folds and <75% of circumference) and D (Mucosal break ≥75% of circumference). |
| Week 4 |
| Heartburn symptoms stratified by combination of response at Week 2 and baseline endoscopic findings (improvement and grade N, improvement and grade M, non-improvement and grade N, non-improvement and grade M.) | Heartburn symptoms will be collected by participant diaries. Percentage of symptom-free days, cumulative symptom improvement rate, and severity of heartburn symptoms are evaluation parameters. | Week 4 |
| Abiko-shi |
| Chiba |
| Japan |
| Kashiwa-shi | Chiba | Japan |
| Noda | Chiba | Japan |
| Yachiyo-shi | Chiba | Japan |
| Saijo-shi | Ehime | Japan |
| Fukuoka | Fukuoka | Japan |
| Itoshima-shi | Fukuoka | Japan |
| Kasuya-gun | Fukuoka | Japan |
| Onga-gun | Fukuoka | Japan |
| Kouriyama-shi | Fukushima | Japan |
| Gifu | Gifu | Japan |
| Takayama-shi | Gifu | Japan |
| Annaka-shi | Gunma | Japan |
| Hiroshima | Hiroshima | Japan |
| Asahikawa-shi | Hokkaido | Japan |
| Sapporo | Hokkaido | Japan |
| Amagasaki-shi | Hyōgo | Japan |
| Kobe | Hyōgo | Japan |
| Nishinomiya-shi | Hyōgo | Japan |
| Takarazuka-shi | Hyōgo | Japan |
| Sagamihara-shi | Kanagawa | Japan |
| Yokohama | Kanagawa | Japan |
| Kochi | Kochi | Japan |
| Suzaki-shi | Kochi | Japan |
| Kumamoto | Kumamoto | Japan |
| Kyoto | Kyoto | Japan |
| Sendai | Miyagi | Japan |
| Nagasaki | Nagasaki | Japan |
| Ōita | Oita Prefecture | Japan |
| Okayama | Okayama-ken | Japan |
| Osaka | Osaka | Japan |
| Takatsuki-shi | Osaka | Japan |
| Saga | Saga-ken | Japan |
| Kumagaya-shi | Saitama | Japan |
| Saitama-shi | Saitama | Japan |
| Tokorozawa-shi | Saitama | Japan |
| Otawara-shi | Tochigi | Japan |
| Bunkyo-ku | Tokyo | Japan |
| Chiyoda-ku | Tokyo | Japan |
| Chuo-ku | Tokyo | Japan |
| Hachioji-shi | Tokyo | Japan |
| Kokubunji-shi | Tokyo | Japan |
| Nakano-ku | Tokyo | Japan |
| Oota-ku | Tokyo | Japan |
| Setagaya-ku | Tokyo | Japan |
| Shibuya-ku | Tokyo | Japan |
| Shinjuku-ku | Tokyo | Japan |
| Shimonoseki-shi | Yamaguchi | Japan |
| Kofu | Yamanashi | Japan |
| Turu-shi | Yamanashi | Japan |
| Yamagata | Ymagata | Japan |
| ID | Term |
|---|---|
| C552956 | 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine |
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