Long-term Extension Study 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, 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 Non-steroidal Anti-inflammatory Drug (NSAID)
3 other identifiers
interventional
406
1 country
97
Brief Summary
The purpose of this study is to evaluate the safety of TAK-438, once daily (QD), during long-term concomitant non-steroidal anti-inflammatory drug (NSAID) therapy in patients with a history of gastric or duodenal ulcer who require long-term therapy of NSAID.
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 Sep 2011
97 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
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 16, 2011
CompletedFirst Posted
Study publicly available on registry
October 20, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedMay 8, 2014
May 1, 2014
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
EXPERIMENTALLansoprazole 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 NSAID 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 NSAID
- 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 (97)
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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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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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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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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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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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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
- 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
September 1, 2011
Study Completion
December 1, 2013
Last Updated
May 8, 2014
Record last verified: 2014-05