Efficacy and Safety of TAK-438 for the Prevention of Recurrent Gastric or Duodenal Ulcers During Therapy of Non-steroidal Anti-inflammatory Drug (NSAID)
A Phase 3, Multicenter, Randomized, Double-blind, AG-1749-controlled, Parallel-group, Comparison Study to Evaluate the Efficacy and Safety of TAK-438 (10 mg or 20 mg, Orally, Once Daily) for the Prevention of Recurrent Gastric or Duodenal Ulcers During Long-term Therapy of Non-steroidal Anti-inflammatory Drug (NSAID).
3 other identifiers
interventional
642
1 country
102
Brief Summary
The purpose of this study is to evaluate the efficacy of TAK-438, once daily (QD), compared to AG-1749 (Lansoprazole) in patients with a history of gastric or duodenal ulcer who require long-term therapy of non-steroidal anti-Inflammatory drug (NSAID).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2011
102 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 16, 2011
CompletedStudy Start
First participant enrolled
October 1, 2011
CompletedFirst Posted
Study publicly available on registry
October 17, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedFebruary 5, 2014
February 1, 2014
1.7 years
September 16, 2011
February 4, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Recurrence rate of gastric or duodenal ulcer within 24 weeks
Mucosal defects with a white coating of 3 mm or larger will be determined as ulcers. Recurrence rate of gastric or duodenal ulcer within 24 weeks will be calculated for each treatment group.
24 weeks
Secondary Outcomes (5)
Recurrence rate of gastric or duodenal ulcer within 12 weeks
12 weeks
Gastric mucosal injury
24 Weeks
Duodenal mucosal injury
24 weeks
Occurrence rate of hemorrhagic lesion in stomach or duodenum
24 weeks
Time to recurrence of gastric or duodenal ulcer
24 weeks
Study Arms (3)
TAK-438 10 mg QD
EXPERIMENTALTAK-438 20 mg QD
EXPERIMENTALLansoprazole 15 mg QD
ACTIVE COMPARATORInterventions
Lansoprazole placebo-matching capsules, orally, once daily for up to 24 weeks.
Lansoprazole 15 mg capsules, orally, once daily for up to 24 weeks.
Eligibility Criteria
You may qualify if:
- Participants who require continuous NSAID therapy during the treatment period with the study drug
- Participants who have a history of ulcer in stomach or duodenum, endoscopically confirmed
- Outpatient (including inpatient for examinations)
You may not qualify if:
- Participants scheduled to change the type and dosage regimen of NSAID
- Participants with ulcers or bleeding in stomach or duodenum, endoscopically confirmed
- Participants with small intestine bleeding, large intestine bleeding, or gastrointestinal bleeding of unknown etiology
- 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
- Participants with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders
- Participants with a previous or current history of aspirin-induced asthma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (102)
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Kasugai-shi, Aichi-ken, Japan
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Nagoya, Aichi-ken, Japan
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Seto-shi, Aichi-ken, Japan
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Akita, Akita, Japan
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Funabashi-shi, Chiba, Japan
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Ichihara-shi, Chiba, Japan
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Nagareyama-shi, Chiba, Japan
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Matsuyama, Ehime, Japan
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Niihama-shi, Ehime, Japan
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Saijo-shi, Ehime, Japan
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Fukui-shi, Fukui, Japan
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Fukuoka, Fukuoka, Japan
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Itoshima-shi, Fukuoka, Japan
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Kitakyusyu-shi, Fukuoka, Japan
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Munakata-shi, Fukuoka, Japan
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Onga-gun, Fukuoka, Japan
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Tagawa-shi, Fukuoka, Japan
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Yukuhashi-shi, Fukuoka, Japan
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Fukushima, Fukushima, Japan
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Koriyama-shi, Fukushima, Japan
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Gifu, Gifu, Japan
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Mebashi-shi, Gunma, Japan
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Takasaki-shi, Gunma, Japan
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Fukuyama-shi, Hiroshima, Japan
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Hatsukaichi-shi, Hiroshima, Japan
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Higashihirosima-shi, Hiroshima, Japan
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Asahikawa-shi, Hokkaido, Japan
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Hakodate-shi, Hokkaido, Japan
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Obihiro-shi, Hokkaido, Japan
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Sapporo, Hokkaido, Japan
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Sunagawa-shi, Hokkaido, Japan
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Tomakomai-shi, Hokkaido, Japan
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Akashi-shi, Hyōgo, Japan
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Himeji-shi, Hyōgo, Japan
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Itami-shi, Hyōgo, Japan
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Kako-gun, Hyōgo, Japan
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Kato-shi, Hyōgo, Japan
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Kobe, Hyōgo, Japan
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Nishinomiya-shi, Hyōgo, Japan
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Higashiibaragi-gun, Ibaragi, Japan
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Koga-shi, Ibaragi, Japan
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Mito, Ibaragi, Japan
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Hitachi-shi, Ibaraki, Japan
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Hakusan-shi, Ishikawa-ken, Japan
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Komatsu-shi, Ishikawa-ken, Japan
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Takamatsu, Kagawa-ken, Japan
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Kamakura-shi, Kanagawa, Japan
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Kawasaki-shi, Kanagawa, Japan
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Sagamihara-shi, Kanagawa, Japan
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Yokohama, Kanagawa, Japan
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Kochi, Kochi, Japan
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Kumamoto, Kumamoto, Japan
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Uji-shi, Kyoto, Japan
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Tsu, Mie-ken, Japan
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Sendai, Miyagi, Japan
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Matsumoto-shi, Nagano, Japan
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Nagano, Nagano, Japan
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Nagasaki, Nagasaki, Japan
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Ikoma-shi, Nara, Japan
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Nara, Nara, Japan
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Nigata-shi, Niigata, Japan
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Beppu-shi, Oita Prefecture, Japan
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Ōita, Oita Prefecture, Japan
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Yuhu-shi, Oita Prefecture, Japan
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Kurashiki-shi, Okayama-ken, Japan
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Higashiosaka-shi, Osaka, Japan
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Moriguchi-shi, Osaka, Japan
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Osaka, Osaka, Japan
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Osakasayama-shi, Osaka, Japan
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Tondabayashi-shi, Osaka, Japan
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Ogi-shi, Saga-ken, Japan
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Saga, Saga-ken, Japan
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Ageo-shi, Saitama, Japan
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Hiki-gun, Saitama, Japan
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Kasukabe-shi, Saitama, Japan
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Kumagaya-shi, Saitama, Japan
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Saitama-shi, Saitama, Japan
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Sayama-shi, Saitama, Japan
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Toda-shi, Saitama, Japan
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Tokorozawa-shi, Saitama, Japan
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Ōtsu, Shiga, Japan
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Izumo-shi, Shimane, Japan
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Hamamatsu, Shizuoka, Japan
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Shizuoka, Shizuoka, Japan
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Naruto-shi, Tokushima, Japan
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Adachi-ku, Tokyo, Japan
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Bunkyo-ku, Tokyo, Japan
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Hachiouji-shi, Tokyo, Japan
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Koto-ku, Tokyo, Japan
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Meguro-ku, Tokyo, Japan
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Minato-ku, Tokyo, Japan
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Mitaka-shi, Tokyo, Japan
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Musashimurayama-shi, Tokyo, Japan
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Nakano-ku, Tokyo, Japan
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Ōta-ku, Tokyo, Japan
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Setagaya-ku, Tokyo, Japan
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Sumida-ku, Tokyo, Japan
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Yonago-shi, Tottori, Japan
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Tonami-shi, Toyama, Japan
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Toyama, Toyama, Japan
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Shimonoseki-shi, Yamaguchi, Japan
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Ube-shi, Yamaguchi, Japan
Related Publications (1)
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.
PMID: 28988197DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Senior Manager
Takeda
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2011
First Posted
October 17, 2011
Study Start
October 1, 2011
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
February 5, 2014
Record last verified: 2014-02