Back to resultsEfficacy and Safety of TAK-438 for the Prevention of Recurrent Gastric or Duodenal Ulcers During Therapy of Low-dose Aspirin
Primary Purpose
Gastric Ulcers, Duodenal Ulcers
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
TAK-438
Placebo
TAK-438
Placebo
Lansoprazole
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Gastric Ulcers focused on measuring Drug Therapy
Eligibility Criteria
Inclusion Criteria:
- Participants who require continuous low-dose aspirin 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)
Exclusion Criteria:
- Participants scheduled to change the type and dosage regimen of low-dose aspirin
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
TAK-438 10 mg QD
TAK-438 20 mg QD
Lansoprazole 15 mg QD
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Recurrence rate of gastric or duodenal ulcer within 12 weeks
Gastric mucosal injury
Duodenal mucosal injury
Occurrence rate of hemorrhagic lesion in stomach or duodenum
Time to recurrence of gastric or duodenal ulcer
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01452763
Brief Title
Efficacy and Safety of TAK-438 for the Prevention of Recurrent Gastric or Duodenal Ulcers During Therapy of Low-dose Aspirin
Official Title
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 Low-dose Aspirin
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 low-dose aspirin.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Ulcers, Duodenal Ulcers
Keywords
Drug Therapy
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
621 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TAK-438 10 mg QD
Arm Type
Experimental
Arm Title
TAK-438 20 mg QD
Arm Type
Experimental
Arm Title
Lansoprazole 15 mg QD
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
TAK-438
Intervention Description
TAK-438 10 mg tablets, orally, once daily for up to 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Lansoprazole placebo-matching capsules, orally, once daily for up to 24 weeks.
Intervention Type
Drug
Intervention Name(s)
TAK-438
Intervention Description
TAK-438 20 mg tablets, orally, once daily for up to 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Lansoprazole placebo-matching capsules, orally, once daily for up to 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Lansoprazole
Other Intervention Name(s)
AG-1749
Intervention Description
Lansoprazole 15 mg capsules, orally, once daily for up to 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
TAK-438 placebo-matching tablets, orally, once daily for up to 24 weeks.
Primary Outcome Measure Information:
Title
Recurrence rate of gastric or duodenal ulcer within 24 weeks
Description
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.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Recurrence rate of gastric or duodenal ulcer within 12 weeks
Time Frame
12 weeks
Title
Gastric mucosal injury
Time Frame
24 Weeks
Title
Duodenal mucosal injury
Time Frame
24 weeks
Title
Occurrence rate of hemorrhagic lesion in stomach or duodenum
Time Frame
24 weeks
Title
Time to recurrence of gastric or duodenal ulcer
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants who require continuous low-dose aspirin 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)
Exclusion Criteria:
Participants scheduled to change the type and dosage regimen of low-dose aspirin
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Senior Manager
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
City
Komaki-shi
State/Province
Aichi
Country
Japan
City
Seto-shi
State/Province
Aichi
Country
Japan
City
Akita-shi
State/Province
Akita
Country
Japan
City
Ichikawa-shi
State/Province
Chiba
Country
Japan
City
Kisarazu-shi
State/Province
Chiba
Country
Japan
City
Matsudo-shi
State/Province
Chiba
Country
Japan
City
Imabari-shi
State/Province
Ehime
Country
Japan
City
Matsuyama-shi
State/Province
Ehime
Country
Japan
City
Niihama-shi
State/Province
Ehime
Country
Japan
City
Fukui-shi
State/Province
Fukui
Country
Japan
City
Chikushino-shi
State/Province
Fukuoka
Country
Japan
City
Fukuoka-shi
State/Province
Fukuoka
Country
Japan
City
Kasuya-gun
State/Province
Fukuoka
Country
Japan
City
Kitakyushu-shi
State/Province
Fukuoka
Country
Japan
City
Miyako-gun
State/Province
Fukuoka
Country
Japan
City
Onga-gun
State/Province
Fukuoka
Country
Japan
City
Yanagawa-shi
State/Province
Fukuoka
Country
Japan
City
Yukuhashi-shi
State/Province
Fukuoka
Country
Japan
City
Koriyama-shi
State/Province
Fukushima
Country
Japan
City
Gifu-shi
State/Province
Gifu
Country
Japan
City
Takasaki-shi
State/Province
Gunma
Country
Japan
City
Fukuyama-shi
State/Province
Hiroshima
Country
Japan
City
Hatsukaichi-shi
State/Province
Hiroshima
Country
Japan
City
Hiroshima-shi
State/Province
Hiroshima
Country
Japan
City
Asahikawa-shi
State/Province
Hokkaido
Country
Japan
City
Obihiro-shi
State/Province
Hokkaido
Country
Japan
City
Sapporo-shi
State/Province
Hokkaido
Country
Japan
City
Tomakomaki-shi
State/Province
Hokkaido
Country
Japan
City
Kobe-shi
State/Province
Hyougo
Country
Japan
City
Nishinomiya-shi
State/Province
Hyougo
Country
Japan
City
Takarazuka-shi
State/Province
Hyougo
Country
Japan
City
Koga-shi
State/Province
Ibaragi
Country
Japan
City
Tsuchiura-shi
State/Province
Ibaragi
Country
Japan
City
Kanazawa-shi
State/Province
Ishikawa
Country
Japan
City
Komatsu-shi
State/Province
Ishikawa
Country
Japan
City
Nomi-shi
State/Province
Ishikawa
Country
Japan
City
Shiroyama-shi
State/Province
Ishikawa
Country
Japan
City
Takamatsu-shi
State/Province
Kagawa
Country
Japan
City
Ibusuki-shi
State/Province
Kagoshima
Country
Japan
City
Ichikikushikino-shi
State/Province
Kagoshima
Country
Japan
City
Izumi-shi
State/Province
Kagoshima
Country
Japan
City
Atsugi-shi
State/Province
Kanagawa
Country
Japan
City
Kawasaki-shi
State/Province
Kanagawa
Country
Japan
City
Sagamihara-shi
State/Province
Kanagawa
Country
Japan
City
Yokohama-shi
State/Province
Kanagawa
Country
Japan
City
Kochi-shi
State/Province
Kochi
Country
Japan
City
Kumamoto-shi
State/Province
Kumamoto
Country
Japan
City
Kyoto-shi
State/Province
Kyoto
Country
Japan
City
Uji-shi
State/Province
Kyoto
Country
Japan
City
Tsu-shi
State/Province
Mie
Country
Japan
City
Sendai-shi
State/Province
Miyagi
Country
Japan
City
Nagasaki-shi
State/Province
Nagasaki
Country
Japan
City
Nara-shi
State/Province
Nara
Country
Japan
City
Niigata-shi
State/Province
Niigata
Country
Japan
City
Oita-shi
State/Province
Oita
Country
Japan
City
Osaka-shi
State/Province
Osaka
Country
Japan
City
Sakai-shi
State/Province
Osaka
Country
Japan
City
Tondabayashi-shi
State/Province
Osaka
Country
Japan
City
Ageo-shi
State/Province
Saitama
Country
Japan
City
Hiki-gun
State/Province
Saitama
Country
Japan
City
Kumagaya-shi
State/Province
Saitama
Country
Japan
City
Saitama-shi
State/Province
Saitama
Country
Japan
City
Sayama-shi
State/Province
Saitama
Country
Japan
City
Tokorozawa-shi
State/Province
Saitama
Country
Japan
City
Otsu-shi
State/Province
Shiga
Country
Japan
City
Utsunomiya-shi
State/Province
Tochigi
Country
Japan
City
Adachi-ku
State/Province
Tokyo
Country
Japan
City
Hachioji-shi
State/Province
Tokyo
Country
Japan
City
Koto-ku
State/Province
Tokyo
Country
Japan
City
Meguro-ku
State/Province
Tokyo
Country
Japan
City
Minato-ku
State/Province
Tokyo
Country
Japan
City
Shinjuku-ku
State/Province
Tokyo
Country
Japan
City
Tonami-shi
State/Province
Toyama
Country
Japan
City
Toyama-shi
State/Province
Toyama
Country
Japan
City
Iwakuni-shi
State/Province
Yamaguchi
Country
Japan
City
Shimonoseki-shi
State/Province
Yamaguchi
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
29196436
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.
Results Reference
derived
Learn more about this trial
Efficacy and Safety of TAK-438 for the Prevention of Recurrent Gastric or Duodenal Ulcers During Therapy of Low-dose Aspirin
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