Efficacy and Safety of TAK-438 Compared to AG-1749 (Lansoprazole) in the Treatment of Duodenal Ulcer
Study Details
Study Description
Brief Summary
The purpose of this study is to determine the efficacy of TAK-438, once daily (QD), compared to lansoprazole in patients with duodenal ulcer.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: TAK-438 20 mg QD
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Drug: TAK-438
TAK-438 20 mg, tablets, orally, once daily for up to 6 weeks.
Drug: Placebo
Lansoprazole placebo-matching capsules, orally, once daily for up to 6 weeks.
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Active Comparator: Lansoprazole 30 mg QD
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Drug: Lansoprazole
Lansoprazole 30 mg, capsules, orally, once daily for up to 6 weeks.
Other Names:
Drug: Placebo
TAK-438 placebo-matching tablets, orally, once daily for up to 6 weeks.
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Outcome Measures
Primary Outcome Measures
- Endoscopic Healing Rate of Duodenal Ulcer Over 6 Weeks [6 weeks]
Endoscopic healing rate : Rate of participants who have endoscopically confirmed all of the white coatings disappeared.
Secondary Outcome Measures
- 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 [Baseline and 6 weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Participants must have endoscopically confirmed duodenal ulcers (mucosal defect with white coating) .At least one ulcer with white coating of 5 mm or larger in size should be observed at baseline (Visit 1).
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Outpatient (including short inpatient for examination and others)
Exclusion Criteria:
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Participants with a gastric ulcer which is suspected to be malignant on endoscopy at baseline (Visit 1)
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Participants with an Acute Duodenal Mucosal Lesion (ADML) on endoscopy at baseline (Visit 1)
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Participants with a linear ulcer (including scarring) on endoscopy at baseline (Visit
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Participants with a postoperative ulcer (e.g., Ulcer after EMR/ESD) on endoscopy at baseline (Visit 1)
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Participants with a gastric ulcer on endoscopy at baseline (Visit 1)
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Participants with an ulcer for which medical treatment is not indicated (e.g.,perforation, pyloric stenosis, duodenal stenosis, large hemorrhage)
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Participants who have received endoscopic hemostasis for gastric ulcer within 30 days prior to baseline (Visit 1)
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Participants with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders
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Participants who have received or who are scheduled to undergo surgery which affects gastric acid secretion (e.g., resection of upper gastrointestinal tract, vagotomy)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Toyota-shi | Aichi | Japan | ||
2 | Kamagaya-shi | Chiba | Japan | ||
3 | Kisarazu-shi | Chiba | Japan | ||
4 | Fukui-shi | Fukui | Japan | ||
5 | Fukuoka-shi | Fukuoka | Japan | ||
6 | Kitakyushu-shi | Fukuoka | Japan | ||
7 | Kurume-shi | Fukuoka | Japan | ||
8 | Onga-gun | Fukuoka | Japan | ||
9 | Tagawa-shi | Fukuoka | Japan | ||
10 | Yanagawa-shi | Fukuoka | Japan | ||
11 | Yukuhashi-shi | Fukuoka | Japan | ||
12 | Sappori-shi | Hokkaido | Japan | ||
13 | Kobe-shi | Hyogo | Japan | ||
14 | Nishinomiya-shi | Hyogo | Japan | ||
15 | Takarazuka-shi | Hyogo | Japan | ||
16 | Hitachi-shi | Ibaraki | Japan | ||
17 | Hitacinaka-shi | Ibaraki | Japan | ||
18 | Marugame-shi | Kagawa | Japan | ||
19 | Takamatsu-shi | Kagawa | Japan | ||
20 | Kagoshima-shi | Kagoshima | Japan | ||
21 | Kanoya-shi | Kagoshima | Japan | ||
22 | Kawasaki-shi | Kanagawa | Japan | ||
23 | Yokohama-shi | Kanagawa | Japan | ||
24 | Kumamoto-shi | Kumamoto | Japan | ||
25 | Yashiro-shi | Kumamoto | Japan | ||
26 | Kyoto-shi | Kyoto | Japan | ||
27 | Nagasaki-shi | Nagasaki | Japan | ||
28 | Sasebo-shi | Nagasaki | Japan | ||
29 | Oita-shi | Oita | Japan | ||
30 | Okayama-shi | Okayama | Japan | ||
31 | Shimajiri-gun | Okinawa | Japan | ||
32 | Daito-shi | Osaka | Japan | ||
33 | Fujiidera-shi | Osaka | Japan | ||
34 | Hirakata-shi | Osaka | Japan | ||
35 | Kishiwada-shi | Osaka | Japan | ||
36 | Osaka-shi | Osaka | Japan | ||
37 | Sakai-shi | Osaka | Japan | ||
38 | Suita-shi | Osaka | Japan | ||
39 | Takatsuki-shi | Osaka | Japan | ||
40 | Toyonaka-shi | Osaka | Japan | ||
41 | Saga-shi | Saga | Japan | ||
42 | Ageo-shi | Saitama | Japan | ||
43 | Kumagaya-shi | Saitama | Japan | ||
44 | Tokorozawa-shi | Saitama | Japan | ||
45 | Otsu-shi | Shiga | Japan | ||
46 | Shizuoka-shi | Shizuoka | Japan | ||
47 | Ashikaga-shi | Tochigi | Japan | ||
48 | Otawara-shi | Tochigi | Japan | ||
49 | Shimotsuga-gun | Tochigi | Japan | ||
50 | Shimotsuke-shi | Tochigi | Japan | ||
51 | Tokushima-shi | Tokushima | Japan | ||
52 | Hachioji-shi | Tokyo | Japan | ||
53 | Kodaira-shi | Tokyo | Japan | ||
54 | Kokubunji-shi | Tokyo | Japan | ||
55 | Meguro-ku | Tokyo | Japan | ||
56 | Minato-ku | Tokyo | Japan | ||
57 | Mitaka-shi | Tokyo | Japan | ||
58 | Ota-ku | Tokyo | Japan | ||
59 | Setagaya-ku | Tokyo | Japan | ||
60 | Shinagawa-ku | Tokyo | Japan | ||
61 | Wakayama-shi | Wakayama | Japan | ||
62 | Yamagata-shi | Yamagata | Japan | ||
63 | Shimonoseki-shi | Yamaguchi | Japan | ||
64 | Kofu-shi | Yamanashi | Japan |
Sponsors and Collaborators
- Takeda
Investigators
- Study Director: Senior Manager, Takeda
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TAK-438/CCT-102
- U1111-1123-8648
- JapicCTI-111608