Efficacy and Safety of TAK-438 for the Prevention of Recurrent Gastric or Duodenal Ulcers During Therapy of Non-steroidal Anti-inflammatory Drug (NSAID)
NCT ID: NCT01452750
Last Updated: 2014-02-05
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
642 participants
INTERVENTIONAL
2011-10-31
2013-06-30
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
QUADRUPLE
Study Groups
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TAK-438 10 mg QD
TAK-438
TAK-438 10 mg tablets, orally, once daily for up to 24 weeks.
Placebo
Lansoprazole placebo-matching capsules, orally, once daily for up to 24 weeks.
TAK-438 20 mg QD
TAK-438
TAK-438 20 mg tablets, orally, once daily for up to 24 weeks.
Placebo
Lansoprazole placebo-matching capsules, orally, once daily for up to 24 weeks.
Lansoprazole 15 mg QD
Lansoprazole
Lansoprazole 15 mg capsules, orally, once daily for up to 24 weeks.
Placebo
TAK-438 placebo-matching tablets, orally, once daily for up to 24 weeks.
Interventions
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TAK-438
TAK-438 10 mg tablets, orally, once daily for up to 24 weeks.
Placebo
Lansoprazole placebo-matching capsules, orally, once daily for up to 24 weeks.
TAK-438
TAK-438 20 mg tablets, orally, once daily for up to 24 weeks.
Placebo
Lansoprazole placebo-matching capsules, orally, once daily for up to 24 weeks.
Lansoprazole
Lansoprazole 15 mg capsules, orally, once daily for up to 24 weeks.
Placebo
TAK-438 placebo-matching tablets, orally, once daily for up to 24 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Participants who have a history of ulcer in stomach or duodenum, endoscopically confirmed
3. Outpatient (including inpatient for examinations)
Exclusion Criteria
2. Participants with ulcers or bleeding in stomach or duodenum, endoscopically confirmed
3. Participants with small intestine bleeding, large intestine bleeding, or gastrointestinal bleeding of unknown etiology
4. 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
5. Participants with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders
6. 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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Kasugai-shi, Aichi-ken, Japan
Nagoya, Aichi-ken, Japan
Seto-shi, Aichi-ken, Japan
Akita, Akita, Japan
Funabashi-shi, Chiba, Japan
Ichihara-shi, Chiba, Japan
Nagareyama-shi, Chiba, Japan
Matsuyama, Ehime, Japan
Niihama-shi, Ehime, Japan
Saijo-shi, Ehime, Japan
Fukui-shi, Fukui, Japan
Fukuoka, Fukuoka, Japan
Itoshima-shi, Fukuoka, Japan
Kitakyusyu-shi, Fukuoka, Japan
Munakata-shi, Fukuoka, Japan
Onga-gun, Fukuoka, Japan
Tagawa-shi, Fukuoka, Japan
Yukuhashi-shi, Fukuoka, Japan
Fukushima, Fukushima, Japan
Koriyama-shi, Fukushima, Japan
Gifu, Gifu, Japan
Mebashi-shi, Gunma, Japan
Takasaki-shi, Gunma, Japan
Fukuyama-shi, Hiroshima, Japan
Hatsukaichi-shi, Hiroshima, Japan
Higashihirosima-shi, Hiroshima, Japan
Asahikawa-shi, Hokkaido, Japan
Hakodate-shi, Hokkaido, Japan
Obihiro-shi, Hokkaido, Japan
Sapporo, Hokkaido, Japan
Sunagawa-shi, Hokkaido, Japan
Tomakomai-shi, Hokkaido, Japan
Akashi-shi, Hyōgo, Japan
Himeji-shi, Hyōgo, Japan
Itami-shi, Hyōgo, Japan
Kako-gun, Hyōgo, Japan
Kato-shi, Hyōgo, Japan
Kobe, Hyōgo, Japan
Nishinomiya-shi, Hyōgo, Japan
Higashiibaragi-gun, Ibaragi, Japan
Koga-shi, Ibaragi, Japan
Mito, Ibaragi, Japan
Hitachi-shi, Ibaraki, Japan
Hakusan-shi, Ishikawa-ken, Japan
Komatsu-shi, Ishikawa-ken, Japan
Takamatsu, Kagawa-ken, Japan
Kamakura-shi, Kanagawa, Japan
Kawasaki-shi, Kanagawa, Japan
Sagamihara-shi, Kanagawa, Japan
Yokohama, Kanagawa, Japan
Kochi, Kochi, Japan
Kumamoto, Kumamoto, Japan
Uji-shi, Kyoto, Japan
Tsu, Mie-ken, Japan
Sendai, Miyagi, Japan
Matsumoto-shi, Nagano, Japan
Nagano, Nagano, Japan
Nagasaki, Nagasaki, Japan
Ikoma-shi, Nara, Japan
Nara, Nara, Japan
Nigata-shi, Niigata, Japan
Beppu-shi, Oita Prefecture, Japan
Ōita, Oita Prefecture, Japan
Yuhu-shi, Oita Prefecture, Japan
Kurashiki-shi, Okayama-ken, Japan
Higashiosaka-shi, Osaka, Japan
Moriguchi-shi, Osaka, Japan
Osaka, Osaka, Japan
Osakasayama-shi, Osaka, Japan
Tondabayashi-shi, Osaka, Japan
Ogi-shi, Saga-ken, Japan
Saga, Saga-ken, Japan
Ageo-shi, Saitama, Japan
Hiki-gun, Saitama, Japan
Kasukabe-shi, Saitama, Japan
Kumagaya-shi, Saitama, Japan
Saitama-shi, Saitama, Japan
Sayama-shi, Saitama, Japan
Toda-shi, Saitama, Japan
Tokorozawa-shi, Saitama, Japan
Ōtsu, Shiga, Japan
Izumo-shi, Shimane, Japan
Hamamatsu, Shizuoka, Japan
Shizuoka, Shizuoka, Japan
Naruto-shi, Tokushima, Japan
Adachi-ku, Tokyo, Japan
Bunkyo-ku, Tokyo, Japan
Hachiouji-shi, Tokyo, Japan
Koto-ku, Tokyo, Japan
Meguro-ku, Tokyo, Japan
Minato-ku, Tokyo, Japan
Mitaka-shi, Tokyo, Japan
Musashimurayama-shi, Tokyo, Japan
Nakano-ku, Tokyo, Japan
Ōta-ku, Tokyo, Japan
Setagaya-ku, Tokyo, Japan
Sumida-ku, Tokyo, Japan
Yonago-shi, Tottori, Japan
Tonami-shi, Toyama, Japan
Toyama, Toyama, Japan
Shimonoseki-shi, Yamaguchi, Japan
Ube-shi, Yamaguchi, Japan
Countries
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References
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Mizokami Y, Oda K, Funao N, Nishimura A, Soen S, Kawai T, Ashida K, Sugano K. Vonoprazan prevents ulcer recurrence during long-term NSAID therapy: randomised, lansoprazole-controlled non-inferiority and single-blind extension study. Gut. 2018 Jun;67(6):1042-1051. doi: 10.1136/gutjnl-2017-314010. Epub 2017 Oct 7.
Other Identifiers
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U1111-1123-8722
Identifier Type: REGISTRY
Identifier Source: secondary_id
JapicCTI-111613
Identifier Type: REGISTRY
Identifier Source: secondary_id
TAK-438/CCT-301
Identifier Type: -
Identifier Source: org_study_id
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