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Comparison of TAK-438 (Vonoprazan) to Lansoprazole in the Treatment of Gastric Ulcer Participants With or Without Helicobacter Pylori Infection

Primary Purpose

Gastric Ulcer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
TAK-438
Lansoprazole
TAK-438 Placebo
Lansoprazole Placebo
Bismuth-Containing Quadruple Therapy
Sponsored by
Takeda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Ulcer focused on measuring Drug therapy

Eligibility Criteria

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

Inclusion Criteria:

1. Has endoscopic evidence of active gastric ulcer(s) (i.e. mucosal defects with white coating [including cases associated with blood coagula as long as there is no active bleeding]) measuring 5 mm or larger in longest diameter within 14 days prior to randomization.

Exclusion Criteria:

  1. Has received TAK-438 in a previous clinical study or as a therapeutic agent.
  2. Has a history or clinical manifestations of significant central nervous system (CNS), cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urological, endocrine or hematological disease that, in the opinion of the investigator, would confound the study results or compromise participant safety.
  3. Has been treated with Helicobacter pylori eradication therapy within 30 days prior to study treatment.
  4. Has any gastric ulcer of >2 cm in any diameter or with >3 separate gastric ulcers in total as evident by endoscopy within 14 days prior to randomization.
  5. Has a diagnosis of gastric malignancy or a gastric ulcer whose morphology suggested malignancy as evident by endoscopy within 14 days prior to randomization.
  6. Is suspected of having acute gastro-duodenal mucosal lesions (AGDML) as evident by endoscopy within 14 days prior to randomization.
  7. Has a linear ulcer (including a linear ulcer scar) that has been confirmed by endoscopy within 14 days prior to randomization.
  8. Has active postoperative (e.g. endoscopic mucosal resection/endoscopic submucosal dissection) ulcer(s) as confirmed by endoscopy within 14 days prior to randomization.
  9. Has duodenal ulcer that has been confirmed by endoscopy within 14 days prior to randomization.
  10. Has ulcers for which medical therapy alone is not indicated (e.g., perforation, pyloric stenosis, duodenal stenosis, major bleeding).
  11. Has undergone therapeutic upper gastrointestinal (GI) endoscopic therapy (e.g., endoscopic hemostasis or excision including biopsy) within 30 days prior to visit 1.
  12. Has Zollinger-Ellison syndrome or gastric acid hypersecretion or those with a history of gastric acid hypersecretion.
  13. Has undergone major surgical procedures within 30 days prior to Visit 1 or are scheduled to undergo surgical procedures that may affect gastric acid secretion (e.g., abdominal surgery, vagotomy or craniotomy).
  14. Has a history of malignancy or was treated for malignancy within 5 years before the start of the visit 1 (the participant may be included in the study if he/she has cured cutaneous basal cell carcinoma or cervical carcinoma in situ).
  15. Has a known acquired immunodeficiency syndrome or hepatitis infection, including hepatitis virus carriers (hepatitis B surface-antigen [HBsAg] - or hepatitis C virus (HCV)-antibody-positive) (the participant may be included in the study if he/she is HCV-viral load-RNA-negative).

  16. Laboratory tests performed prior to randomization revealed any of the following abnormalities in the participant:

    1. Creatinine levels: >2 mg/dL (>177 μmol/L).
    2. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST), or total bilirubin levels: > upper limit of normal (ULN).
  17. Has hypersensitivity to TAK-438, proton pump inhibitors (PPIs), bismuth, clarithromycin, or amoxicillin. Skin testing may be performed according to local standard practice (for HP+ participants only).

Sites / Locations

  • The First Affiliated Hospital of Anhui Medical University
  • Yijishan hospital of Wan nan Medical college
  • Peking University First Hospital
  • Beijing Chao Yang Hospital
  • The General Hospital of People's Armed Police Forces China
  • The Central Hospital of China Aerospace Corporation
  • Beijing Friendship Hospital, Capital Medical University
  • Beijing Tong Ren Hospital, Capital Medical University
  • The Second Affiliated Hospital of Chongqing Medical University
  • Fuzhou General Hospital of Nanjing Military Area Command of Chinese PLA
  • The First Affiliated Hospital of Xiamen University
  • Zhangzhou Hospital
  • The First People's Hospital of Foshan
  • Guangdong General Hospital
  • The Sixth Affiliated Hospital of Sun Yat-Sen University
  • Peking University Shenzhen Hospital
  • Haikou People's Hospital
  • Shiyan Taihe Hospital
  • Jingzhou Central Hospital
  • Union Hospital of Tongji Medical College of Huazhong Science and Techology University
  • Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
  • Wuhan General Hospital of Guangzhou Military
  • The 2nd Xiangya Hospital Central South University
  • Chenzhou No.1 People's Hospital
  • Changsha Central Hospital
  • The First People's Hospital of Changzhou
  • Nanjing First Hospital
  • Wuxi 4th People's Hospital
  • Wuxi People's Hospital
  • Affiliated Hospital of Jiangsu University
  • The First Affiliated Hospital of NanChang University
  • Jiangxi Nanchang 3rd Hospital
  • Jiangxi Pingxiang People's Hospital
  • The First Hospital of Jilin University
  • Jilin 4th People'S hospital
  • China-Japan Union Hospital of Jilin University
  • Jilin central Hospital
  • Jilin Siping Central Hospital
  • General Hospital of Shenyang Military Region
  • General Hospital of Ningxia Medical University
  • People's Hospital of Qinghai Province
  • Ruijin Hospital, Shanghai Jiaotong Uni. School of Med.
  • Zhongshan Hospital Fudan University
  • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
  • Shanghai Tongji Hospital
  • The 2nd Hospital of Xi An Jiaotong University
  • Tianjin Medical University Affiliated General Hospital
  • The First Affiliated Hospital of Kunming Medical College
  • 1st Affiliated Hospital of Zhejiang University
  • Zhejiang Hospital
  • Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
  • The Second Affiliated Hospital of Wenzhou Medical College
  • The Second Affiliated Hospital Zhejiang University School of Medicine
  • Yonsei University Wonju Severance Christian Hospital
  • Korea University Ansan Hospital
  • The Catholic University of Korea, Bucheon St. Mary s Hospital
  • Hanyang Univerisy Guri Hospital
  • Seoul National University Bundang Hospital
  • The Catholic University of Korea, St. Vincent's Hospital
  • Wonkwang University Hospital
  • Chonbuk National University Hospital
  • Dong-A University Hospital
  • Kyungpook National University Hospital
  • Yeungnam University Hospital
  • Chonnam National University Hospital
  • The Catholic University of Korea, Incheon St. Mary's Hospital
  • Gachon University Gil Medical Center
  • Korea University Anam Hospital
  • Kangbuk Samsung Hospital
  • Severance Hospital, Yonsei University
  • Cebu Doctors University Hospital
  • De La Salle University Medical Center
  • Davao Doctors Hospital
  • West Visayas State University Medical Center
  • Philippine General Hospital
  • St. Luke's Medical Center Global City
  • China Medical University Hospital
  • National Taiwan University Hospital
  • Taipei Veterans General Hospital
  • Tri-Service General Hospital
  • Chang Gung Memorial Hospital, Linkou

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

TAK-438 20 mg

Lansoprazole 30 mg

Arm Description

Helicobacter Pylori positive (HP+) participants: TAK-438 20 mg tablet, twice daily (BID) along with lansoprazole placebo-matching, capsule BID in addition to bismuth-containing quadruple antibiotic therapy for the first 2 weeks. Following 2 weeks of eradication therapy participants received TAK-438 20 mg QD along with lansoprazole matching placebo 30 mg, capsule QD for up to 6 weeks. HP negative (HP-) participants: TAK-438 20 mg tablet, (QD) along with lansoprazole matching placebo, 30 mg capsule QD for up to 8 weeks.

HP+ participants: Lansoprazole 30 mg, capsule, orally, BID and TAK-438 placebo-matching tablet, orally, BID along with bismuth-containing quadruple antibiotic therapy for first 2 weeks. Following 2 weeks participants received Lansoprazole 30 mg, capsule, orally, QD along with TAK-438 placebo-matching tablet, orally, QD for up to 6 weeks. HP- participants: Lansoprazole 30 mg, capsule, orally, QD along with TAK-438 placebo-matching tablet, orally, QD for up to 8 weeks.

Outcomes

Primary Outcome Measures

Percentage of Participants With Endoscopically Confirmed Healing of Gastric Ulcers (GUs) at Weeks 4 or 8
Endoscopic healing was defined as the disappearance of all white coats associated with GUs confirmed endoscopically.

Secondary Outcome Measures

Percentage of Helicobacter Pylori Infected (HP+) Participants With Successful HP Eradication After 4 or 8 Weeks of Treatment
HP infection status was determined by 13C-UBT. The urea breath test is used to detect infection with HP, a bacteria associated with stomach ulcers, by testing individual breath samples in a central laboratory. The data is provided only for HP+ participants. The participant could take 4 or 8 weeks of treatment for GU healing, then additional 4 weeks later, to have the urea breath test (UBT) test to detect HP.
Percentage of Participants With Endoscopically Confirmed Healing of GU at Week 4
Endoscopic healing was defined as the disappearance of all white coats associated with GUs confirmed endoscopically.
Percentage of Participants With Post-treatment Resolution of Gastrointestinal Symptoms Associated With GU
The gastrointestinal symptoms included epigastric pain [postprandial, fasting, nocturnal], abdominal bloating, nausea/vomiting, heartburn, lack of appetite. The severity of gastrointestinal symptoms associated with GU were recorded as: none = 0, mild = 1, moderate = 2 or severe = 3. The data is reported in categories for percentage of participants with resolution of gastrointestinal symptoms associated with GU.

Full Information

First Posted
February 8, 2017
Last Updated
May 24, 2021
Sponsor
Takeda
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1. Study Identification

Unique Protocol Identification Number
NCT03050307
Brief Title
Comparison of TAK-438 (Vonoprazan) to Lansoprazole in the Treatment of Gastric Ulcer Participants With or Without Helicobacter Pylori Infection
Official Title
A Randomized Double-Blind, Double-Dummy, Phase 3 Study to Evaluate the Efficacy and Safety of Oral TAK-438 20mg Compared to Lansoprazole 30mg Once- or Twice-Daily in the Treatment of Endoscopically Confirmed Gastric Ulcer Subjects With or Without Helicobacter Pylori Infection
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
April 17, 2017 (Actual)
Primary Completion Date
February 19, 2020 (Actual)
Study Completion Date
May 26, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to demonstrate the non-inferior efficacy of TAK-438 versus lansoprazole in the treatment of participants with gastric ulcer.
Detailed Description
The drug being tested in this study is called TAK-438. TAK-438 is being tested to treat people who have stomach ulcers and also may or may not have Helicobacter pylori (HP) infection. This study will look at stomach ulcer healing and also the elimination of HP in people who take TAK-438 versus lansoprazole. The study will enroll approximately 830 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which will remain undisclosed to the participants and study doctor during the study (unless there is an urgent medical need): TAK-438 20 mg Lansoprazole 30 mg Study treatment will depend upon the Helicobacter pylori infection status of the participant, and include bismuth-containing quadruple therapy for the first 2 weeks in H pylori infected (HP+) participants. HP+ participants will be asked to take a TAK- 438 tablet or a lansoprazole capsule twice daily in conjunction with bismuth-containing quadruple therapy for 2 weeks, followed up by a TAK-438 tablet or a lansoprazole capsule once daily for up to 6 weeks. HP- participants will be asked to take a TAK-438 tablet or a lansoprazole capsule once daily for up to 8 weeks. This multi-center trial will be conducted in China, Korea, Taiwan, and Philippines. The overall time to participate in this study is up to 12 weeks. Participants will make multiple visits plus final visit at 2 weeks or 4 weeks after last dose of study drug for a follow-up assessment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Ulcer
Keywords
Drug therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
234 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TAK-438 20 mg
Arm Type
Experimental
Arm Description
Helicobacter Pylori positive (HP+) participants: TAK-438 20 mg tablet, twice daily (BID) along with lansoprazole placebo-matching, capsule BID in addition to bismuth-containing quadruple antibiotic therapy for the first 2 weeks. Following 2 weeks of eradication therapy participants received TAK-438 20 mg QD along with lansoprazole matching placebo 30 mg, capsule QD for up to 6 weeks. HP negative (HP-) participants: TAK-438 20 mg tablet, (QD) along with lansoprazole matching placebo, 30 mg capsule QD for up to 8 weeks.
Arm Title
Lansoprazole 30 mg
Arm Type
Experimental
Arm Description
HP+ participants: Lansoprazole 30 mg, capsule, orally, BID and TAK-438 placebo-matching tablet, orally, BID along with bismuth-containing quadruple antibiotic therapy for first 2 weeks. Following 2 weeks participants received Lansoprazole 30 mg, capsule, orally, QD along with TAK-438 placebo-matching tablet, orally, QD for up to 6 weeks. HP- participants: Lansoprazole 30 mg, capsule, orally, QD along with TAK-438 placebo-matching tablet, orally, QD for up to 8 weeks.
Intervention Type
Drug
Intervention Name(s)
TAK-438
Other Intervention Name(s)
Vonoprazan
Intervention Description
TAK-438 tablets
Intervention Type
Drug
Intervention Name(s)
Lansoprazole
Other Intervention Name(s)
Prevacid
Intervention Description
Lansoprazole capsules
Intervention Type
Drug
Intervention Name(s)
TAK-438 Placebo
Intervention Description
TAK-438 placebo-matching tablets
Intervention Type
Drug
Intervention Name(s)
Lansoprazole Placebo
Intervention Description
Lansoprazole placebo-matching capsules
Intervention Type
Drug
Intervention Name(s)
Bismuth-Containing Quadruple Therapy
Intervention Description
1 g Amoxicillin, 500 mg clarithromycin and 600 mg bismuth potassium citrate/bismuth tripotassium dicitrate, twice daily (BID).
Primary Outcome Measure Information:
Title
Percentage of Participants With Endoscopically Confirmed Healing of Gastric Ulcers (GUs) at Weeks 4 or 8
Description
Endoscopic healing was defined as the disappearance of all white coats associated with GUs confirmed endoscopically.
Time Frame
Week 4 or 8
Secondary Outcome Measure Information:
Title
Percentage of Helicobacter Pylori Infected (HP+) Participants With Successful HP Eradication After 4 or 8 Weeks of Treatment
Description
HP infection status was determined by 13C-UBT. The urea breath test is used to detect infection with HP, a bacteria associated with stomach ulcers, by testing individual breath samples in a central laboratory. The data is provided only for HP+ participants. The participant could take 4 or 8 weeks of treatment for GU healing, then additional 4 weeks later, to have the urea breath test (UBT) test to detect HP.
Time Frame
4 weeks post treatment (up to approximately 12 weeks)
Title
Percentage of Participants With Endoscopically Confirmed Healing of GU at Week 4
Description
Endoscopic healing was defined as the disappearance of all white coats associated with GUs confirmed endoscopically.
Time Frame
Week 4
Title
Percentage of Participants With Post-treatment Resolution of Gastrointestinal Symptoms Associated With GU
Description
The gastrointestinal symptoms included epigastric pain [postprandial, fasting, nocturnal], abdominal bloating, nausea/vomiting, heartburn, lack of appetite. The severity of gastrointestinal symptoms associated with GU were recorded as: none = 0, mild = 1, moderate = 2 or severe = 3. The data is reported in categories for percentage of participants with resolution of gastrointestinal symptoms associated with GU.
Time Frame
Week 2 up to Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Has endoscopic evidence of active gastric ulcer(s) (i.e. mucosal defects with white coating [including cases associated with blood coagula as long as there is no active bleeding]) measuring 5 mm or larger in longest diameter within 14 days prior to randomization. Exclusion Criteria: Has received TAK-438 in a previous clinical study or as a therapeutic agent. Has a history or clinical manifestations of significant central nervous system (CNS), cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urological, endocrine or hematological disease that, in the opinion of the investigator, would confound the study results or compromise participant safety. Has been treated with Helicobacter pylori eradication therapy within 30 days prior to study treatment. Has any gastric ulcer of >2 cm in any diameter or with >3 separate gastric ulcers in total as evident by endoscopy within 14 days prior to randomization. Has a diagnosis of gastric malignancy or a gastric ulcer whose morphology suggested malignancy as evident by endoscopy within 14 days prior to randomization. Is suspected of having acute gastro-duodenal mucosal lesions (AGDML) as evident by endoscopy within 14 days prior to randomization. Has a linear ulcer (including a linear ulcer scar) that has been confirmed by endoscopy within 14 days prior to randomization. Has active postoperative (e.g. endoscopic mucosal resection/endoscopic submucosal dissection) ulcer(s) as confirmed by endoscopy within 14 days prior to randomization. Has duodenal ulcer that has been confirmed by endoscopy within 14 days prior to randomization. Has ulcers for which medical therapy alone is not indicated (e.g., perforation, pyloric stenosis, duodenal stenosis, major bleeding). Has undergone therapeutic upper gastrointestinal (GI) endoscopic therapy (e.g., endoscopic hemostasis or excision including biopsy) within 30 days prior to visit 1. Has Zollinger-Ellison syndrome or gastric acid hypersecretion or those with a history of gastric acid hypersecretion. Has undergone major surgical procedures within 30 days prior to Visit 1 or are scheduled to undergo surgical procedures that may affect gastric acid secretion (e.g., abdominal surgery, vagotomy or craniotomy). Has a history of malignancy or was treated for malignancy within 5 years before the start of the visit 1 (the participant may be included in the study if he/she has cured cutaneous basal cell carcinoma or cervical carcinoma in situ). Has a known acquired immunodeficiency syndrome or hepatitis infection, including hepatitis virus carriers (hepatitis B surface-antigen [HBsAg] - or hepatitis C virus (HCV)-antibody-positive) (the participant may be included in the study if he/she is HCV-viral load-RNA-negative). Laboratory tests performed prior to randomization revealed any of the following abnormalities in the participant: Creatinine levels: >2 mg/dL (>177 μmol/L). Alanine aminotransferase (ALT) or aspartate aminotransferase (AST), or total bilirubin levels: > upper limit of normal (ULN). Has hypersensitivity to TAK-438, proton pump inhibitors (PPIs), bismuth, clarithromycin, or amoxicillin. Skin testing may be performed according to local standard practice (for HP+ participants only).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director Clinical Science
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
The First Affiliated Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230024
Country
China
Facility Name
Yijishan hospital of Wan nan Medical college
City
Wuhu
State/Province
Anhui
ZIP/Postal Code
241001
Country
China
Facility Name
Peking University First Hospital
City
Beijing,P.R.
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Beijing Chao Yang Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China
Facility Name
The General Hospital of People's Armed Police Forces China
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100039
Country
China
Facility Name
The Central Hospital of China Aerospace Corporation
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100049
Country
China
Facility Name
Beijing Friendship Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
Beijing Tong Ren Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
The Second Affiliated Hospital of Chongqing Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
40010
Country
China
Facility Name
Fuzhou General Hospital of Nanjing Military Area Command of Chinese PLA
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350025
Country
China
Facility Name
The First Affiliated Hospital of Xiamen University
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361003
Country
China
Facility Name
Zhangzhou Hospital
City
Zhangzhou
State/Province
Fujian
ZIP/Postal Code
363000
Country
China
Facility Name
The First People's Hospital of Foshan
City
Foshan
State/Province
Guangdong
ZIP/Postal Code
528000
Country
China
Facility Name
Guangdong General Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
The Sixth Affiliated Hospital of Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510655
Country
China
Facility Name
Peking University Shenzhen Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518000
Country
China
Facility Name
Haikou People's Hospital
City
Haikou
State/Province
Hainan
ZIP/Postal Code
570208
Country
China
Facility Name
Shiyan Taihe Hospital
City
Shiyan
State/Province
Hebei
ZIP/Postal Code
442000
Country
China
Facility Name
Jingzhou Central Hospital
City
Jingzhou
State/Province
Hubei
ZIP/Postal Code
434020
Country
China
Facility Name
Union Hospital of Tongji Medical College of Huazhong Science and Techology University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
420104
Country
China
Facility Name
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Facility Name
Wuhan General Hospital of Guangzhou Military
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430070
Country
China
Facility Name
The 2nd Xiangya Hospital Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
Facility Name
Chenzhou No.1 People's Hospital
City
Chenzhou
State/Province
Hunan
ZIP/Postal Code
432000
Country
China
Facility Name
Changsha Central Hospital
City
Yuhua
State/Province
Hunan
ZIP/Postal Code
410018
Country
China
Facility Name
The First People's Hospital of Changzhou
City
Changzhou City
State/Province
Jiangsu
ZIP/Postal Code
213003
Country
China
Facility Name
Nanjing First Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210012
Country
China
Facility Name
Wuxi 4th People's Hospital
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214062
Country
China
Facility Name
Wuxi People's Hospital
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
241023
Country
China
Facility Name
Affiliated Hospital of Jiangsu University
City
Zhenjiang
State/Province
Jiangsu
ZIP/Postal Code
212001
Country
China
Facility Name
The First Affiliated Hospital of NanChang University
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Name
Jiangxi Nanchang 3rd Hospital
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330009
Country
China
Facility Name
Jiangxi Pingxiang People's Hospital
City
Pingxiang
State/Province
Jiangxi
ZIP/Postal Code
337055
Country
China
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130000
Country
China
Facility Name
Jilin 4th People'S hospital
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130012
Country
China
Facility Name
China-Japan Union Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130033
Country
China
Facility Name
Jilin central Hospital
City
Jilin
State/Province
Jilin
ZIP/Postal Code
132011
Country
China
Facility Name
Jilin Siping Central Hospital
City
Siping
State/Province
Jilin
ZIP/Postal Code
136000
Country
China
Facility Name
General Hospital of Shenyang Military Region
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110016
Country
China
Facility Name
General Hospital of Ningxia Medical University
City
Yinchuan
State/Province
Ningxia
ZIP/Postal Code
750004
Country
China
Facility Name
People's Hospital of Qinghai Province
City
Xining
State/Province
Qinghai
ZIP/Postal Code
810007
Country
China
Facility Name
Ruijin Hospital, Shanghai Jiaotong Uni. School of Med.
City
Huangpu Qu
State/Province
Shanghai
ZIP/Postal Code
200020
Country
China
Facility Name
Zhongshan Hospital Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200092
Country
China
Facility Name
Shanghai Tongji Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200442
Country
China
Facility Name
The 2nd Hospital of Xi An Jiaotong University
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710004
Country
China
Facility Name
Tianjin Medical University Affiliated General Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300052
Country
China
Facility Name
The First Affiliated Hospital of Kunming Medical College
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650032
Country
China
Facility Name
1st Affiliated Hospital of Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Facility Name
Zhejiang Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310013
Country
China
Facility Name
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310016
Country
China
Facility Name
The Second Affiliated Hospital of Wenzhou Medical College
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325027
Country
China
Facility Name
The Second Affiliated Hospital Zhejiang University School of Medicine
City
Hangzhou
ZIP/Postal Code
310009
Country
China
Facility Name
Yonsei University Wonju Severance Christian Hospital
City
Wonju-si
State/Province
Gangwon-do
ZIP/Postal Code
26426
Country
Korea, Republic of
Facility Name
Korea University Ansan Hospital
City
Ansan-si
State/Province
Gyeonggi-do
ZIP/Postal Code
15355
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Bucheon St. Mary s Hospital
City
Bucheon-si
State/Province
Gyeonggi-do
ZIP/Postal Code
14647
Country
Korea, Republic of
Facility Name
Hanyang Univerisy Guri Hospital
City
Guri-si
State/Province
Gyeonggi-do
ZIP/Postal Code
11923
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, St. Vincent's Hospital
City
Suwon-si
State/Province
Gyeonggi-do
ZIP/Postal Code
16247
Country
Korea, Republic of
Facility Name
Wonkwang University Hospital
City
Iksan-si
State/Province
Jeollabuk-do
ZIP/Postal Code
54538
Country
Korea, Republic of
Facility Name
Chonbuk National University Hospital
City
Jeonju-si
State/Province
Jeollabuk-do
ZIP/Postal Code
54907
Country
Korea, Republic of
Facility Name
Dong-A University Hospital
City
Busan
ZIP/Postal Code
49201
Country
Korea, Republic of
Facility Name
Kyungpook National University Hospital
City
Daegu
ZIP/Postal Code
41944
Country
Korea, Republic of
Facility Name
Yeungnam University Hospital
City
Daegu
ZIP/Postal Code
42415
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital
City
Gwangju
ZIP/Postal Code
61469
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Incheon St. Mary's Hospital
City
Incheon
ZIP/Postal Code
21431
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center
City
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Facility Name
Kangbuk Samsung Hospital
City
Seoul
ZIP/Postal Code
03181
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Cebu Doctors University Hospital
City
Cebu City
ZIP/Postal Code
6000
Country
Philippines
Facility Name
De La Salle University Medical Center
City
Dasmarinas City, Cavite
ZIP/Postal Code
4114
Country
Philippines
Facility Name
Davao Doctors Hospital
City
Davao
ZIP/Postal Code
8000
Country
Philippines
Facility Name
West Visayas State University Medical Center
City
Iloilo City
ZIP/Postal Code
5000
Country
Philippines
Facility Name
Philippine General Hospital
City
Manila
ZIP/Postal Code
1000
Country
Philippines
Facility Name
St. Luke's Medical Center Global City
City
Taguig City
ZIP/Postal Code
1634
Country
Philippines
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Tri-Service General Hospital
City
Taipei
ZIP/Postal Code
11490
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital, Linkou
City
Taoyuan County
ZIP/Postal Code
333
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
IPD Sharing Time Frame
NOTE: IPD Sharing Time Frame has not been entered.
IPD Sharing Access Criteria
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
IPD Sharing URL
https://vivli.org/ourmember/takeda/

Learn more about this trial

Comparison of TAK-438 (Vonoprazan) to Lansoprazole in the Treatment of Gastric Ulcer Participants With or Without Helicobacter Pylori Infection

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