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)
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 NSAID therapy during the treatment period with the study drug
- Participants who have completed the preceding study
- Outpatient (including inpatient for examinations)
Exclusion Criteria:
- 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
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
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.
Secondary Outcome Measures
Change from baseline in Laboratory values
Change from baseline in Electrocardiograms
Change from baseline in Vital signs
Change from baseline in Serum gastrin
Change from baseline in Pepsinogen I and II
Recurrence rate of gastric or duodenal ulcer
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01456260
Brief Title
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
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 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 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.
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
Participant
Allocation
Randomized
Enrollment
406 (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 28-80 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Lansoprazole placebo matching capsules, orally, once daily for 28-80 weeks.
Intervention Type
Drug
Intervention Name(s)
TAK-438
Intervention Description
TAK-438 20 mg tablets, orally, once daily for 28-80 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Lansoprazole placebo-matching capsules, orally, once daily for 28-80 weeks.
Intervention Type
Drug
Intervention Name(s)
Lansoprazole
Other Intervention Name(s)
AG-1749
Intervention Description
Lansoprazole 15 mg capsules, orally, once daily for 28-80 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
TAK-438 placebo-matching tablets, orally, once daily for 28-80 weeks.
Primary Outcome Measure Information:
Title
Incidence of treatment-emergent adverse events
Description
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.
Time Frame
Up to 80 weeks.
Secondary Outcome Measure Information:
Title
Change from baseline in Laboratory values
Time Frame
Up to 80 weeks.
Title
Change from baseline in Electrocardiograms
Time Frame
Up to 80 weeks.
Title
Change from baseline in Vital signs
Time Frame
Up to 80 weeks.
Title
Change from baseline in Serum gastrin
Time Frame
Up to 80 weeks.
Title
Change from baseline in Pepsinogen I and II
Time Frame
Up to 80 weeks.
Title
Recurrence rate of gastric or duodenal ulcer
Time Frame
Up to 80 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Senior Manager
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
City
Kasugai-shi
State/Province
Aichi
Country
Japan
City
Nagoya-shi
State/Province
Aichi
Country
Japan
City
Seto-shi
State/Province
Aichi
Country
Japan
City
Akita-shi
State/Province
Akita
Country
Japan
City
Funabashi-shi
State/Province
Chiba
Country
Japan
City
Ichihara-shi
State/Province
Chiba
Country
Japan
City
Nagareyama-shi
State/Province
Chiba
Country
Japan
City
Matsuyama-shi
State/Province
Ehime
Country
Japan
City
Niihama-shi
State/Province
Ehime
Country
Japan
City
Saijo-shi
State/Province
Ehime
Country
Japan
City
Fukui-shi
State/Province
Fukui
Country
Japan
City
Fukuoka-shi
State/Province
Fukuoka
Country
Japan
City
Itoshima-shi
State/Province
Fukuoka
Country
Japan
City
Kitakyusyu-shi
State/Province
Fukuoka
Country
Japan
City
Munakata-shi
State/Province
Fukuoka
Country
Japan
City
Onga-gun
State/Province
Fukuoka
Country
Japan
City
Tagawa-shi
State/Province
Fukuoka
Country
Japan
City
Yukuhashi-shi
State/Province
Fukuoka
Country
Japan
City
Fukushima-shi
State/Province
Fukushima
Country
Japan
City
Koriyama-shi
State/Province
Fukushima
Country
Japan
City
Mebashi-shi
State/Province
Gunma
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
Higashihirosima-shi
State/Province
Hiroshima
Country
Japan
City
Asahikawa-shi
State/Province
Hokkaido
Country
Japan
City
Hakodate-shi
State/Province
Hokkaido
Country
Japan
City
Obihiro-shi
State/Province
Hokkaido
Country
Japan
City
Sapporo-shi
State/Province
Hokkaido
Country
Japan
City
Sunagawa-shi
State/Province
Hokkaido
Country
Japan
City
Tomakomai-shi
State/Province
Hokkaido
Country
Japan
City
Akashi-shi
State/Province
Hyogo
Country
Japan
City
Himeji-shi
State/Province
Hyogo
Country
Japan
City
Itami-shi
State/Province
Hyogo
Country
Japan
City
Kako-gun
State/Province
Hyogo
Country
Japan
City
Kato-shi
State/Province
Hyogo
Country
Japan
City
Kobe-shi
State/Province
Hyogo
Country
Japan
City
Nishinomiya-shi
State/Province
Hyogo
Country
Japan
City
Higashiibaragi-gun
State/Province
Ibaragi
Country
Japan
City
Koga-shi
State/Province
Ibaragi
Country
Japan
City
Mito-shi
State/Province
Ibaragi
Country
Japan
City
Hakusan-shi
State/Province
Ishikawa
Country
Japan
City
Komatsu-shi
State/Province
Ishikawa
Country
Japan
City
Takamatsu-shi
State/Province
Kagawa
Country
Japan
City
Kamakura-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
Uji-shi
State/Province
Kyoto
Country
Japan
City
Tsu-shi
State/Province
Mie
Country
Japan
City
Sendai-shi
State/Province
Miyagi
Country
Japan
City
Matsumoto-shi
State/Province
Nagano
Country
Japan
City
Nagano-shi
State/Province
Nagano
Country
Japan
City
Nagasaki-shi
State/Province
Nagasaki
Country
Japan
City
Ikoma-shi
State/Province
Nara
Country
Japan
City
Nara-shi
State/Province
Nara
Country
Japan
City
Nigata-shi
State/Province
Nigata
Country
Japan
City
Beppu-shi
State/Province
Oita
Country
Japan
City
Oita-shi
State/Province
Oita
Country
Japan
City
Yuhu-shi
State/Province
Oita
Country
Japan
City
Kurashiki-shi
State/Province
Okayama
Country
Japan
City
Higashiosaka-shi
State/Province
Osaka
Country
Japan
City
Moriguchi-shi
State/Province
Osaka
Country
Japan
City
Osaka-shi
State/Province
Osaka
Country
Japan
City
Osakasayama-shi
State/Province
Osaka
Country
Japan
City
Tondabayashi-shi
State/Province
Osaka
Country
Japan
City
Ogi-shi
State/Province
Saga
Country
Japan
City
Ageo-shi
State/Province
Saitama
Country
Japan
City
Hiki-gun
State/Province
Saitama
Country
Japan
City
Kasukabe-shi
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
Toda-shi
State/Province
Saitama
Country
Japan
City
Tokorozawa-shi
State/Province
Saitama
Country
Japan
City
Otsu-shi
State/Province
Shiga
Country
Japan
City
Hamamatsu-shi
State/Province
Shizuoka
Country
Japan
City
Shizuoka-shi
State/Province
Shizuoka
Country
Japan
City
Naruto-shi
State/Province
Tokushima
Country
Japan
City
Adachi-ku
State/Province
Tokyo
Country
Japan
City
Bunkyo-ku
State/Province
Tokyo
Country
Japan
City
Hachiouji-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
Musashimurayama-shi
State/Province
Tokyo
Country
Japan
City
Nakano-ku
State/Province
Tokyo
Country
Japan
City
Ota-ku
State/Province
Tokyo
Country
Japan
City
Setagaya-ku
State/Province
Tokyo
Country
Japan
City
Sumida-ku
State/Province
Tokyo
Country
Japan
City
Yonago-shi
State/Province
Tottori
Country
Japan
City
Tonami-shi
State/Province
Toyama
Country
Japan
City
Toyama-shi
State/Province
Toyama
Country
Japan
City
Shimonoseki-shi
State/Province
Yamaguchi
Country
Japan
City
Ube-shi
State/Province
Yamaguchi
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
28988197
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.
Results Reference
derived
Learn more about this trial
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)
We'll reach out to this number within 24 hrs