Long-term Extension Study of TAK-438 for the Prevention of Recurrent Gastric or Duodenal Ulcers During Therapy of Low-dose Aspirin
A Phase 3, Multicenter, Single-blind, AG-1749-controlled, Parallel-group, Long-term Extension Study to Evaluate the Safety and Efficacy 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 Low-dose Aspirin
3 other identifiers
interventional
439
1 country
76
Brief Summary
The purpose of this study is to evaluate the safety of TAK-438, once daily (QD), during long-term concomitant low-dose aspirin therapy in patients with a history of gastric or duodenal ulcer who require long-term therapy of low-dose aspirin.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2012
76 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
CompletedFirst Posted
Study publicly available on registry
October 20, 2011
CompletedStudy Start
First participant enrolled
March 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedMay 8, 2014
May 1, 2014
1.6 years
September 16, 2011
May 7, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of treatment-emergent adverse events
Treatment-emergent adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through the last visit of study.
Up to 80 weeks.
Secondary Outcomes (6)
Change from baseline in Laboratory values
Up to 80 weeks.
Change from baseline in Electrocardiograms
Up to 80 weeks.
Change from baseline in Vital signs
Up to 80 weeks.
Change from baseline in Serum gastrin
Up to 80 weeks.
Change from baseline in Pepsinogen I and II
Up to 80 weeks.
- +1 more secondary outcomes
Study Arms (3)
TAK-438 10 mg QD
EXPERIMENTALTAK-438 20 mg QD
EXPERIMENTALAG-1749 15 mg QD
ACTIVE COMPARATORInterventions
Lansoprazole placebo-matching capsules, orally, once daily for 28-80 weeks.
Lansoprazole 15 mg capsules, orally, once daily for 28-80 weeks.
Eligibility Criteria
You may qualify if:
- Participants who require continuous low-dose aspirin therapy during the treatment period with the study drug
- Participants who have completed the preceding study
- Outpatient (including inpatient for examinations)
You may not qualify if:
- Participants deemed to be ineligible to participate in the study by the principal investigator or investigator due to the occurrence of adverse events in the preceding study
- Participants who are scheduled to change the type and dosage regimen of low-dose aspirin
- Participants with ulcers or bleeding in stomach or duodenum, endoscopically confirmed during the preceding study
- 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 (76)
Unknown Facility
Komaki-shi, Aichi-ken, Japan
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Seto-shi, Aichi-ken, Japan
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Akita, Akita, Japan
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Ichikawa-shi, Chiba, Japan
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Kisarazu-shi, Chiba, Japan
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Matsudo-shi, Chiba, Japan
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Imabari, Ehime, Japan
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Matsuyama, Ehime, Japan
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Niihama-shi, Ehime, Japan
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Fukui-shi, Fukui, Japan
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Chikushino-shi, Fukuoka, Japan
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Fukuoka, Fukuoka, Japan
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Kasuya-gun, Fukuoka, Japan
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Kitakyushu-shi, Fukuoka, Japan
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Miyako-gun, Fukuoka, Japan
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Onga-gun, Fukuoka, Japan
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Yanagawa-shi, Fukuoka, Japan
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Yukuhashi-shi, Fukuoka, Japan
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Koriyama-shi, Fukushima, Japan
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Gifu, Gifu, 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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Hiroshima, Hiroshima, Japan
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Asahikawa-shi, Hokkaido, Japan
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Obihiro-shi, Hokkaido, Japan
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Sapporo, Hokkaido, Japan
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Tomakomaki-shi, Hokkaido, Japan
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Kobe, Hyōgo, Japan
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Nishinomiya-shi, Hyōgo, Japan
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Takarazuka-shi, Hyōgo, Japan
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Koga-shi, Ibaragi, Japan
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Tsuchiura-shi, Ibaragi, Japan
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Kanazawa, Ishikawa-ken, Japan
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Komatsu-shi, Ishikawa-ken, Japan
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Nomi-shi, Ishikawa-ken, Japan
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Shiroyama-shi, Ishikawa-ken, Japan
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Takamatsu, Kagawa-ken, Japan
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Ibusuki-shi, Kagoshima-ken, Japan
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Ichikikushikino-shi, Kagoshima-ken, Japan
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Izumi-shi, Kagoshima-ken, Japan
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Atsugi-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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Kyoto, Kyoto, 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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Nagasaki, Nagasaki, Japan
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Nara, Nara, Japan
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Niigata, Niigata, Japan
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Ōita, Oita Prefecture, Japan
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Osaka, Osaka, Japan
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Sakai-shi, Osaka, Japan
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Tondabayashi-shi, Osaka, Japan
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Ageo-shi, Saitama, Japan
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Hiki-gun, 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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Tokorozawa-shi, Saitama, Japan
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Ōtsu, Shiga, Japan
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Utsunomiya, Tochigi, Japan
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Adachi-ku, Tokyo, Japan
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Hachioji-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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Shinjuku-ku, Tokyo, Japan
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Tonami-shi, Toyama, Japan
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Toyama, Toyama, Japan
Unknown Facility
Iwakuni-shi, Yamaguchi, Japan
Unknown Facility
Shimonoseki-shi, Yamaguchi, Japan
Related Publications (1)
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.
PMID: 29196436DERIVED
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
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2011
First Posted
October 20, 2011
Study Start
March 1, 2012
Primary Completion
October 1, 2013
Study Completion
October 1, 2013
Last Updated
May 8, 2014
Record last verified: 2014-05