Long-term Extension Study of TAK-438 for the Prevention of Recurrent Gastric or Duodenal Ulcers During Therapy of Low-dose Aspirin
NCT ID: NCT01456247
Last Updated: 2014-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
439 participants
INTERVENTIONAL
2012-03-31
2013-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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TAK-438 10 mg QD
TAK-438
TAK-438 10 mg tablets, orally, once daily for 28-80 weeks.
Placebo
Lansoprazole placebo-matching capsules, orally, once daily for 28-80 weeks.
TAK-438 20 mg QD
TAK-438
TAK-438 20 mg tablets, orally, once daily for 28-80 weeks.
Placebo
Lansoprazole placebo-matching capsules, orally, once daily for 28-80 weeks.
AG-1749 15 mg QD
Lansoprazole
Lansoprazole 15 mg capsules, orally, once daily for 28-80 weeks.
Placebo
TAK-438 placebo-matching tablets, orally, once daily for 28-80 weeks.
Interventions
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TAK-438
TAK-438 10 mg tablets, orally, once daily for 28-80 weeks.
Placebo
Lansoprazole placebo-matching capsules, orally, once daily for 28-80 weeks.
TAK-438
TAK-438 20 mg tablets, orally, once daily for 28-80 weeks.
Placebo
Lansoprazole placebo-matching capsules, orally, once daily for 28-80 weeks.
Lansoprazole
Lansoprazole 15 mg capsules, orally, once daily for 28-80 weeks.
Placebo
TAK-438 placebo-matching tablets, orally, once daily for 28-80 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Participants who have completed the preceding study
3. Outpatient (including inpatient for examinations)
Exclusion Criteria
2. Participants who are scheduled to change the type and dosage regimen of low-dose aspirin
3. Participants with ulcers or bleeding in stomach or duodenum, endoscopically confirmed during the preceding study
4. Participants with small intestine bleeding, large intestine bleeding, or gastrointestinal bleeding of unknown etiology
5. Participants who have a history of surgery which affects gastric acid secretion (e.g., resection of upper gastrointestinal tract, vagotomy) or who are scheduled to undergo such surgery
6. Participants with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders
7. Participants with a previous or current history of aspirin-induced asthma
20 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Senior Manager
Role: STUDY_DIRECTOR
Takeda
Locations
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Komaki-shi, Aichi-ken, Japan
Seto-shi, Aichi-ken, Japan
Akita, Akita, Japan
Ichikawa-shi, Chiba, Japan
Kisarazu-shi, Chiba, Japan
Matsudo-shi, Chiba, Japan
Imabari, Ehime, Japan
Matsuyama, Ehime, Japan
Niihama-shi, Ehime, Japan
Fukui-shi, Fukui, Japan
Chikushino-shi, Fukuoka, Japan
Fukuoka, Fukuoka, Japan
Kasuya-gun, Fukuoka, Japan
Kitakyushu-shi, Fukuoka, Japan
Miyako-gun, Fukuoka, Japan
Onga-gun, Fukuoka, Japan
Yanagawa-shi, Fukuoka, Japan
Yukuhashi-shi, Fukuoka, Japan
Koriyama-shi, Fukushima, Japan
Gifu, Gifu, Japan
Takasaki-shi, Gunma, Japan
Fukuyama-shi, Hiroshima, Japan
Hatsukaichi-shi, Hiroshima, Japan
Hiroshima, Hiroshima, Japan
Asahikawa-shi, Hokkaido, Japan
Obihiro-shi, Hokkaido, Japan
Sapporo, Hokkaido, Japan
Tomakomaki-shi, Hokkaido, Japan
Kobe, Hyōgo, Japan
Nishinomiya-shi, Hyōgo, Japan
Takarazuka-shi, Hyōgo, Japan
Koga-shi, Ibaragi, Japan
Tsuchiura-shi, Ibaragi, Japan
Kanazawa, Ishikawa-ken, Japan
Komatsu-shi, Ishikawa-ken, Japan
Nomi-shi, Ishikawa-ken, Japan
Shiroyama-shi, Ishikawa-ken, Japan
Takamatsu, Kagawa-ken, Japan
Ibusuki-shi, Kagoshima-ken, Japan
Ichikikushikino-shi, Kagoshima-ken, Japan
Izumi-shi, Kagoshima-ken, Japan
Atsugi-shi, Kanagawa, Japan
Kawasaki-shi, Kanagawa, Japan
Sagamihara-shi, Kanagawa, Japan
Yokohama, Kanagawa, Japan
Kochi, Kochi, Japan
Kumamoto, Kumamoto, Japan
Kyoto, Kyoto, Japan
Uji-shi, Kyoto, Japan
Tsu, Mie-ken, Japan
Sendai, Miyagi, Japan
Nagasaki, Nagasaki, Japan
Nara, Nara, Japan
Niigata, Niigata, Japan
Ōita, Oita Prefecture, Japan
Osaka, Osaka, Japan
Sakai-shi, Osaka, Japan
Tondabayashi-shi, Osaka, Japan
Ageo-shi, Saitama, Japan
Hiki-gun, Saitama, Japan
Kumagaya-shi, Saitama, Japan
Saitama-shi, Saitama, Japan
Sayama-shi, Saitama, Japan
Tokorozawa-shi, Saitama, Japan
Ōtsu, Shiga, Japan
Utsunomiya, Tochigi, Japan
Adachi-ku, Tokyo, Japan
Hachioji-shi, Tokyo, Japan
Koto-ku, Tokyo, Japan
Meguro-ku, Tokyo, Japan
Minato-ku, Tokyo, Japan
Shinjuku-ku, Tokyo, Japan
Tonami-shi, Toyama, Japan
Toyama, Toyama, Japan
Iwakuni-shi, Yamaguchi, Japan
Shimonoseki-shi, Yamaguchi, Japan
Countries
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References
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Kawai T, Oda K, Funao N, Nishimura A, Matsumoto Y, Mizokami Y, Ashida K, Sugano K. Vonoprazan prevents low-dose aspirin-associated ulcer recurrence: randomised phase 3 study. Gut. 2018 Jun;67(6):1033-1041. doi: 10.1136/gutjnl-2017-314852. Epub 2017 Dec 1.
Other Identifiers
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U1111-1123-9658
Identifier Type: REGISTRY
Identifier Source: secondary_id
JapicCTI-111616
Identifier Type: REGISTRY
Identifier Source: secondary_id
TAK-438/OCT-302
Identifier Type: -
Identifier Source: org_study_id
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