Clinical trial NCT01456260: 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)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastric Ulcers
Duodenal Ulcers
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2011-10-20
Enrollment: 406
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

1. Participants who require continuous NSAID therapy during the treatment period with the study drug
2. Participants who have completed the preceding study
3. Outpatient (including inpatient for examinations)

Exclusion Criteria:

1. 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
2. Participants who are scheduled to change the type and dosage regimen of NSAID
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

Primary outcomes:
measure: Incidence of treatment-emergent adverse events
timeFrame: Up to 80 weeks.
Secondary outcomes:
measure: Change from baseline in Laboratory values
timeFrame: Up to 80 weeks.
measure: Change from baseline in Electrocardiograms
timeFrame: Up to 80 weeks.
measure: Change from baseline in Vital signs
timeFrame: Up to 80 weeks.
measure: Change from baseline in Serum gastrin
timeFrame: Up to 80 weeks.
measure: Change from baseline in Pepsinogen I and II
timeFrame: Up to 80 weeks.
measure: Recurrence rate of gastric or duodenal ulcer
timeFrame: Up to 80 weeks.
Other outcomes:
Locations:
city: Kasugai-shi
country: Japan
state: Aichi
city: Nagoya-shi
country: Japan
state: Aichi
city: Seto-shi
country: Japan
state: Aichi
city: Akita-shi
country: Japan
state: Akita
city: Funabashi-shi
country: Japan
state: Chiba
city: Ichihara-shi
country: Japan
state: Chiba
city: Nagareyama-shi
country: Japan
state: Chiba
city: Matsuyama-shi
country: Japan
state: Ehime
city: Niihama-shi
country: Japan
state: Ehime
city: Saijo-shi
country: Japan
state: Ehime
city: Fukui-shi
country: Japan
state: Fukui
city: Fukuoka-shi
country: Japan
state: Fukuoka
city: Itoshima-shi
country: Japan
state: Fukuoka
city: Kitakyusyu-shi
country: Japan
state: Fukuoka
city: Munakata-shi
country: Japan
state: Fukuoka
city: Onga-gun
country: Japan
state: Fukuoka
city: Tagawa-shi
country: Japan
state: Fukuoka
city: Yukuhashi-shi
country: Japan
state: Fukuoka
city: Fukushima-shi
country: Japan
state: Fukushima
city: Koriyama-shi
country: Japan
state: Fukushima
city: Mebashi-shi
country: Japan
state: Gunma
city: Takasaki-shi
country: Japan
state: Gunma
city: Fukuyama-shi
country: Japan
state: Hiroshima
city: Hatsukaichi-shi
country: Japan
state: Hiroshima
city: Higashihirosima-shi
country: Japan
state: Hiroshima
city: Asahikawa-shi
country: Japan
state: Hokkaido
city: Hakodate-shi
country: Japan
state: Hokkaido
city: Obihiro-shi
country: Japan
state: Hokkaido
city: Sapporo-shi
country: Japan
state: Hokkaido
city: Sunagawa-shi
country: Japan
state: Hokkaido
city: Tomakomai-shi
country: Japan
state: Hokkaido
city: Akashi-shi
country: Japan
state: Hyogo
city: Himeji-shi
country: Japan
state: Hyogo
city: Itami-shi
country: Japan
state: Hyogo
city: Kako-gun
country: Japan
state: Hyogo
city: Kato-shi
country: Japan
state: Hyogo
city: Kobe-shi
country: Japan
state: Hyogo
city: Nishinomiya-shi
country: Japan
state: Hyogo
city: Higashiibaragi-gun
country: Japan
state: Ibaragi
city: Koga-shi
country: Japan
state: Ibaragi
city: Mito-shi
country: Japan
state: Ibaragi
city: Hakusan-shi
country: Japan
state: Ishikawa
city: Komatsu-shi
country: Japan
state: Ishikawa
city: Takamatsu-shi
country: Japan
state: Kagawa
city: Kamakura-shi
country: Japan
state: Kanagawa
city: Kawasaki-shi
country: Japan
state: Kanagawa
city: Sagamihara-shi
country: Japan
state: Kanagawa
city: Yokohama-shi
country: Japan
state: Kanagawa
city: Kochi-shi
country: Japan
state: Kochi
city: Kumamoto-shi
country: Japan
state: Kumamoto
city: Uji-shi
country: Japan
state: Kyoto
city: Tsu-shi
country: Japan
state: Mie
city: Sendai-shi
country: Japan
state: Miyagi
city: Matsumoto-shi
country: Japan
state: Nagano
city: Nagano-shi
country: Japan
state: Nagano
city: Nagasaki-shi
country: Japan
state: Nagasaki
city: Ikoma-shi
country: Japan
state: Nara
city: Nara-shi
country: Japan
state: Nara
city: Nigata-shi
country: Japan
state: Nigata
city: Beppu-shi
country: Japan
state: Oita
city: Oita-shi
country: Japan
state: Oita
city: Yuhu-shi
country: Japan
state: Oita
city: Kurashiki-shi
country: Japan
state: Okayama
city: Higashiosaka-shi
country: Japan
state: Osaka
city: Moriguchi-shi
country: Japan
state: Osaka
city: Osaka-shi
country: Japan
state: Osaka
city: Osakasayama-shi
country: Japan
state: Osaka
city: Tondabayashi-shi
country: Japan
state: Osaka
city: Ogi-shi
country: Japan
state: Saga
city: Ageo-shi
country: Japan
state: Saitama
city: Hiki-gun
country: Japan
state: Saitama
city: Kasukabe-shi
country: Japan
state: Saitama
city: Kumagaya-shi
country: Japan
state: Saitama
city: Saitama-shi
country: Japan
state: Saitama
city: Sayama-shi
country: Japan
state: Saitama
city: Toda-shi
country: Japan
state: Saitama
city: Tokorozawa-shi
country: Japan
state: Saitama
city: Otsu-shi
country: Japan
state: Shiga
city: Hamamatsu-shi
country: Japan
state: Shizuoka
city: Shizuoka-shi
country: Japan
state: Shizuoka
city: Naruto-shi
country: Japan
state: Tokushima
city: Adachi-ku
country: Japan
state: Tokyo
city: Bunkyo-ku
country: Japan
state: Tokyo
city: Hachiouji-shi
country: Japan
state: Tokyo
city: Koto-ku
country: Japan
state: Tokyo
city: Meguro-ku
country: Japan
state: Tokyo
city: Minato-ku
country: Japan
state: Tokyo
city: Musashimurayama-shi
country: Japan
state: Tokyo
city: Nakano-ku
country: Japan
state: Tokyo
city: Ota-ku
country: Japan
state: Tokyo
city: Setagaya-ku
country: Japan
state: Tokyo
city: Sumida-ku
country: Japan
state: Tokyo
city: Yonago-shi
country: Japan
state: Tottori
city: Tonami-shi
country: Japan
state: Toyama
city: Toyama-shi
country: Japan
state: Toyama
city: Shimonoseki-shi
country: Japan
state: Yamaguchi
city: Ube-shi
country: Japan
state: Yamaguchi
Study officials:
affiliation: Takeda
name: Senior Manager
role: STUDY_DIRECTOR
References:
citation: 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.