Clinical trial NCT01456247: Long-term Extension Study of TAK-438 for the Prevention of Recurrent Gastric or Duodenal Ulcers During Therapy of Low-dose Aspirin
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 Low-dose Aspirin
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: 439
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 low-dose aspirin therapy in patients with a history of gastric or duodenal ulcer who require long-term therapy of low-dose aspirin.


Eligibility criteria: Inclusion Criteria:

1. Participants who require continuous low-dose aspirin 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 low-dose aspirin
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: Komaki-shi
country: Japan
state: Aichi
city: Seto-shi
country: Japan
state: Aichi
city: Akita-shi
country: Japan
state: Akita
city: Ichikawa-shi
country: Japan
state: Chiba
city: Kisarazu-shi
country: Japan
state: Chiba
city: Matsudo-shi
country: Japan
state: Chiba
city: Imabari-shi
country: Japan
state: Ehime
city: Matsuyama-shi
country: Japan
state: Ehime
city: Niihama-shi
country: Japan
state: Ehime
city: Fukui-shi
country: Japan
state: Fukui
city: Chikushino-shi
country: Japan
state: Fukuoka
city: Fukuoka-shi
country: Japan
state: Fukuoka
city: Kasuya-gun
country: Japan
state: Fukuoka
city: Kitakyushu-shi
country: Japan
state: Fukuoka
city: Miyako-gun
country: Japan
state: Fukuoka
city: Onga-gun
country: Japan
state: Fukuoka
city: Yanagawa-shi
country: Japan
state: Fukuoka
city: Yukuhashi-shi
country: Japan
state: Fukuoka
city: Koriyama-shi
country: Japan
state: Fukushima
city: Gifu-shi
country: Japan
state: Gifu
city: Takasaki-shi
country: Japan
state: Gunma
city: Fukuyama-shi
country: Japan
state: Hiroshima
city: Hatsukaichi-shi
country: Japan
state: Hiroshima
city: Hiroshima-shi
country: Japan
state: Hiroshima
city: Asahikawa-shi
country: Japan
state: Hokkaido
city: Obihiro-shi
country: Japan
state: Hokkaido
city: Sapporo-shi
country: Japan
state: Hokkaido
city: Tomakomaki-shi
country: Japan
state: Hokkaido
city: Kobe-shi
country: Japan
state: Hyougo
city: Nishinomiya-shi
country: Japan
state: Hyougo
city: Takarazuka-shi
country: Japan
state: Hyougo
city: Koga-shi
country: Japan
state: Ibaragi
city: Tsuchiura-shi
country: Japan
state: Ibaragi
city: Kanazawa-shi
country: Japan
state: Ishikawa
city: Komatsu-shi
country: Japan
state: Ishikawa
city: Nomi-shi
country: Japan
state: Ishikawa
city: Shiroyama-shi
country: Japan
state: Ishikawa
city: Takamatsu-shi
country: Japan
state: Kagawa
city: Ibusuki-shi
country: Japan
state: Kagoshima
city: Ichikikushikino-shi
country: Japan
state: Kagoshima
city: Izumi-shi
country: Japan
state: Kagoshima
city: Atsugi-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: Kyoto-shi
country: Japan
state: Kyoto
city: Uji-shi
country: Japan
state: Kyoto
city: Tsu-shi
country: Japan
state: Mie
city: Sendai-shi
country: Japan
state: Miyagi
city: Nagasaki-shi
country: Japan
state: Nagasaki
city: Nara-shi
country: Japan
state: Nara
city: Niigata-shi
country: Japan
state: Niigata
city: Oita-shi
country: Japan
state: Oita
city: Osaka-shi
country: Japan
state: Osaka
city: Sakai-shi
country: Japan
state: Osaka
city: Tondabayashi-shi
country: Japan
state: Osaka
city: Ageo-shi
country: Japan
state: Saitama
city: Hiki-gun
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: Tokorozawa-shi
country: Japan
state: Saitama
city: Otsu-shi
country: Japan
state: Shiga
city: Utsunomiya-shi
country: Japan
state: Tochigi
city: Adachi-ku
country: Japan
state: Tokyo
city: Hachioji-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: Shinjuku-ku
country: Japan
state: Tokyo
city: Tonami-shi
country: Japan
state: Toyama
city: Toyama-shi
country: Japan
state: Toyama
city: Iwakuni-shi
country: Japan
state: Yamaguchi
city: Shimonoseki-shi
country: Japan
state: Yamaguchi
Study officials:
affiliation: Takeda
name: Senior Manager
role: STUDY_DIRECTOR
References:
citation: 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.