Comparison of TAK-438 (Vonoprazan) to Lansoprazole in the Treatment of Gastric Ulcer Participants With or Without Helicobacter Pylori Infection
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
3 other identifiers
interventional
234
4 countries
81
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2017
Typical duration for phase_3
81 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 8, 2017
CompletedFirst Posted
Study publicly available on registry
February 10, 2017
CompletedStudy Start
First participant enrolled
April 17, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 19, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 26, 2020
CompletedResults Posted
Study results publicly available
June 18, 2021
CompletedJune 18, 2021
May 1, 2021
2.8 years
February 8, 2017
May 24, 2021
May 24, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Week 4 or 8
Secondary Outcomes (3)
Percentage of Helicobacter Pylori Infected (HP+) Participants With Successful HP Eradication After 4 or 8 Weeks of Treatment
4 weeks post treatment (up to approximately 12 weeks)
Percentage of Participants With Endoscopically Confirmed Healing of GU at Week 4
Week 4
Percentage of Participants With Post-treatment Resolution of Gastrointestinal Symptoms Associated With GU
Week 2 up to Week 8
Study Arms (2)
TAK-438 20 mg
EXPERIMENTALHelicobacter 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.
Lansoprazole 30 mg
EXPERIMENTALHP+ 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.
Interventions
1 g Amoxicillin, 500 mg clarithromycin and 600 mg bismuth potassium citrate/bismuth tripotassium dicitrate, twice daily (BID).
Eligibility Criteria
You may qualify if:
- \. 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.
You may not qualify if:
- 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).
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (81)
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230024, China
Yijishan hospital of Wan nan Medical college
Wuhu, Anhui, 241001, China
Beijing Chao Yang Hospital
Beijing, Beijing Municipality, 100020, China
The General Hospital of People's Armed Police Forces China
Beijing, Beijing Municipality, 100039, China
The Central Hospital of China Aerospace Corporation
Beijing, Beijing Municipality, 100049, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050, China
Beijing Tong Ren Hospital, Capital Medical University
Beijing, Beijing Municipality, 100730, China
Peking University First Hospital
Beijing,P.R., Beijing Municipality, 100034, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 40010, China
Fuzhou General Hospital of Nanjing Military Area Command of Chinese PLA
Fuzhou, Fujian, 350025, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003, China
Zhangzhou Hospital
Zhangzhou, Fujian, 363000, China
The First People's Hospital of Foshan
Foshan, Guangdong, 528000, China
Guangdong General Hospital
Guangzhou, Guangdong, 510080, China
The Sixth Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, 510655, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518000, China
Haikou People's Hospital
Haikou, Hainan, 570208, China
Shiyan Taihe Hospital
Shiyan, Hebei, 442000, China
The 2nd Xiangya Hospital Central South University
Changsha, Hu'nan, 410011, China
Chenzhou No.1 People's Hospital
Chenzhou, Hu'nan, 432000, China
Changsha Central Hospital
Yuhua, Hu'nan, 410018, China
Jingzhou Central Hospital
Jingzhou, Hubei, 434020, China
Union Hospital of Tongji Medical College of Huazhong Science and Techology University
Wuhan, Hubei, 420104, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei, 430030, China
Wuhan General Hospital of Guangzhou Military
Wuhan, Hubei, 430070, China
The First People's Hospital of Changzhou
Changzhou, Jiangsu, 213003, China
Nanjing First Hospital
Nanjing, Jiangsu, 210012, China
Wuxi 4th People's Hospital
Wuxi, Jiangsu, 214062, China
Wuxi People's Hospital
Wuxi, Jiangsu, 241023, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, 212001, China
The First Affiliated Hospital of NanChang University
Nanchang, Jiangxi, 330006, China
Jiangxi Nanchang 3rd Hospital
Nanchang, Jiangxi, 330009, China
Jiangxi Pingxiang People's Hospital
Pingxiang, Jiangxi, 337055, China
The First Hospital of Jilin University
Changchun, Jilin, 130000, China
Jilin 4th People'S hospital
Changchun, Jilin, 130012, China
China-Japan Union Hospital of Jilin University
Changchun, Jilin, 130033, China
Jilin central Hospital
Jilin, Jilin, 132011, China
Jilin Siping Central Hospital
Siping, Jilin, 136000, China
General Hospital of Shenyang Military Region
Shenyang, Liaoning, 110016, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia Hui, 750004, China
People's Hospital of Qinghai Province
Xining, Qinghai, 810007, China
The 2nd Hospital of Xi An Jiaotong University
Xi'an, Shan'xi, 710004, China
Ruijin Hospital, Shanghai Jiaotong Uni. School of Med.
Huangpu Qu, Shanghai Municipality, 200020, China
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032, China
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200092, China
Shanghai Tongji Hospital
Shanghai, Shanghai Municipality, 200442, China
Tianjin Medical University Affiliated General Hospital
Tianjin, Tianjin Municipality, 300052, China
The First Affiliated Hospital of Kunming Medical College
Kunming, Yun'nan, 650032, China
1st Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310003, China
Zhejiang Hospital
Hangzhou, Zhejiang, 310013, China
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
Hangzhou, Zhejiang, 310016, China
The Second Affiliated Hospital of Wenzhou Medical College
Wenzhou, Zhejiang, 325027, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, 310009, China
Cebu Doctors University Hospital
Cebu City, 6000, Philippines
St. Luke's Medical Center Global City
City of Taguig, 1634, Philippines
De La Salle University Medical Center
Dasmarinas City, Cavite, 4114, Philippines
Davao Doctors Hospital
Davao City, 8000, Philippines
West Visayas State University Medical Center
Iloilo City, 5000, Philippines
Philippine General Hospital
Manila, 1000, Philippines
Yonsei University Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, 26426, South Korea
Korea University Ansan Hospital
Ansan-si, Gyeonggi-do, 15355, South Korea
The Catholic University of Korea, Bucheon St. Mary s Hospital
Bucheon-si, Gyeonggi-do, 14647, South Korea
Hanyang Univerisy Guri Hospital
Guri-si, Gyeonggi-do, 11923, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
The Catholic University of Korea, St. Vincent's Hospital
Suwon, Gyeonggi-do, 16247, South Korea
Wonkwang University Hospital
Iksan-si, Jeollabuk-do, 54538, South Korea
Chonbuk National University Hospital
Jeonju, Jeollabuk-do, 54907, South Korea
Dong-A University Hospital
Busan, 49201, South Korea
Kyungpook National University Hospital
Daegu, 41944, South Korea
Yeungnam University Hospital
Daegu, 42415, South Korea
Chonnam National University Hospital
Gwangju, 61469, South Korea
The Catholic University of Korea, Incheon St. Mary's Hospital
Incheon, 21431, South Korea
Gachon University Gil Medical Center
Incheon, 21565, South Korea
Korea University Anam Hospital
Seoul, 02841, South Korea
Kangbuk Samsung Hospital
Seoul, 03181, South Korea
Severance Hospital, Yonsei University
Seoul, 03722, South Korea
China Medical University Hospital
Taichung, 40447, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Tri-Service General Hospital
Taipei, 11490, Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan, 333, Taiwan
Related Publications (1)
Hou X, Wang J, Du Q, Tian D, Hu N, Liu D, Zhou F, Xie L, Gu L, Kudou K, Zhang S. Efficacy and Safety of Vonoprazan-Based Quadruple Therapy for the Eradication of Helicobacter pylori in Patients with Peptic Ulcers: A Pooled Analysis of Two Randomized, Double-Blind, Double-Dummy, Phase 3 Trials. Biol Pharm Bull. 2024;47(8):1405-1414. doi: 10.1248/bpb.b24-00011.
PMID: 39085080DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Takeda
Study Officials
- STUDY DIRECTOR
Study Director Clinical Science
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 8, 2017
First Posted
February 10, 2017
Study Start
April 17, 2017
Primary Completion
February 19, 2020
Study Completion
May 26, 2020
Last Updated
June 18, 2021
Results First Posted
June 18, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- NOTE: IPD Sharing Time Frame has not been entered.
- 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.
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.