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Efficacy and Safety 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
Takeda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gastric Ulcers focused on measuring Drug Therapy

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Participants who require continuous NSAID therapy during the treatment period with the study drug
  2. Participants who have a history of ulcer in stomach or duodenum, endoscopically confirmed
  3. Outpatient (including inpatient for examinations)

Exclusion Criteria:

  1. Participants scheduled to change the type and dosage regimen of NSAID
  2. Participants with ulcers or bleeding in stomach or duodenum, endoscopically confirmed
  3. Participants with small intestine bleeding, large intestine bleeding, or gastrointestinal bleeding of unknown etiology
  4. 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
  5. Participants with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders
  6. 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

First Posted
September 16, 2011
Last Updated
February 4, 2014
Sponsor
Takeda
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1. Study Identification

Unique Protocol Identification Number
NCT01452750
Brief Title
Efficacy and Safety 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, 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 Non-steroidal Anti-inflammatory Drug (NSAID).
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 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 non-steroidal anti-Inflammatory drug (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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
642 (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 NSAID 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 NSAID 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
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
Gifu-shi
State/Province
Gifu
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
Hitachi-shi
State/Province
Ibaraki
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
Saga-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
Izumo-shi
State/Province
Shimane
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
Mitaka-shi
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

Efficacy and Safety of TAK-438 for the Prevention of Recurrent Gastric or Duodenal Ulcers During Therapy of Non-steroidal Anti-inflammatory Drug (NSAID)

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