Gastric Ulcer Clinical Trial
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
Verified date | May 2021 |
Source | Takeda |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 234 |
Est. completion date | May 26, 2020 |
Est. primary completion date | February 19, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
China | Beijing Chao Yang Hospital | Beijing | Beijing |
China | Beijing Friendship Hospital, Capital Medical University | Beijing | Beijing |
China | Beijing Tong Ren Hospital, Capital Medical University | Beijing | Beijing |
China | The Central Hospital of China Aerospace Corporation | Beijing | Beijing |
China | The General Hospital of People's Armed Police Forces China | Beijing | Beijing |
China | Peking University First Hospital | Beijing,P.R. | Beijing |
China | China-Japan Union Hospital of Jilin University | Changchun | Jilin |
China | Jilin 4th People'S hospital | Changchun | Jilin |
China | The First Hospital of Jilin University | Changchun | Jilin |
China | The 2nd Xiangya Hospital Central South University | Changsha | Hunan |
China | The First People's Hospital of Changzhou | Changzhou City | Jiangsu |
China | Chenzhou No.1 People's Hospital | Chenzhou | Hunan |
China | The Second Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing |
China | The First People's Hospital of Foshan | Foshan | Guangdong |
China | Fuzhou General Hospital of Nanjing Military Area Command of Chinese PLA | Fuzhou | Fujian |
China | Guangdong General Hospital | Guangzhou | Guangdong |
China | The Sixth Affiliated Hospital of Sun Yat-Sen University | Guangzhou | Guangdong |
China | Haikou People's Hospital | Haikou | Hainan |
China | 1st Affiliated Hospital of Zhejiang University | Hangzhou | Zhejiang |
China | Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine | Hangzhou | Zhejiang |
China | The Second Affiliated Hospital Zhejiang University School of Medicine | Hangzhou | |
China | Zhejiang Hospital | Hangzhou | Zhejiang |
China | The First Affiliated Hospital of Anhui Medical University | Hefei | Anhui |
China | Ruijin Hospital, Shanghai Jiaotong Uni. School of Med. | Huangpu Qu | Shanghai |
China | Jilin central Hospital | Jilin | Jilin |
China | Jingzhou Central Hospital | Jingzhou | Hubei |
China | The First Affiliated Hospital of Kunming Medical College | Kunming | Yunnan |
China | Jiangxi Nanchang 3rd Hospital | Nanchang | Jiangxi |
China | The First Affiliated Hospital of NanChang University | Nanchang | Jiangxi |
China | Nanjing First Hospital | Nanjing | Jiangsu |
China | Jiangxi Pingxiang People's Hospital | Pingxiang | Jiangxi |
China | Shanghai Tongji Hospital | Shanghai | Shanghai |
China | Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai |
China | Zhongshan Hospital Fudan University | Shanghai | Shanghai |
China | General Hospital of Shenyang Military Region | Shenyang | Liaoning |
China | Peking University Shenzhen Hospital | Shenzhen | Guangdong |
China | Shiyan Taihe Hospital | Shiyan | Hebei |
China | Jilin Siping Central Hospital | Siping | Jilin |
China | Tianjin Medical University Affiliated General Hospital | Tianjin | Tianjin |
China | The Second Affiliated Hospital of Wenzhou Medical College | Wenzhou | Zhejiang |
China | Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology | Wuhan | Hubei |
China | Union Hospital of Tongji Medical College of Huazhong Science and Techology University | Wuhan | Hubei |
China | Wuhan General Hospital of Guangzhou Military | Wuhan | Hubei |
China | Yijishan hospital of Wan nan Medical college | Wuhu | Anhui |
China | Wuxi 4th People's Hospital | Wuxi | Jiangsu |
China | Wuxi People's Hospital | Wuxi | Jiangsu |
China | The 2nd Hospital of Xi An Jiaotong University | Xi'an | Shanxi |
China | The First Affiliated Hospital of Xiamen University | Xiamen | Fujian |
China | People's Hospital of Qinghai Province | Xining | Qinghai |
China | General Hospital of Ningxia Medical University | Yinchuan | Ningxia |
China | Changsha Central Hospital | Yuhua | Hunan |
China | Zhangzhou Hospital | Zhangzhou | Fujian |
China | Affiliated Hospital of Jiangsu University | Zhenjiang | Jiangsu |
Korea, Republic of | Korea University Ansan Hospital | Ansan-si | Gyeonggi-do |
Korea, Republic of | The Catholic University of Korea, Bucheon St. Mary s Hospital | Bucheon-si | Gyeonggi-do |
Korea, Republic of | Dong-A University Hospital | Busan | |
Korea, Republic of | Kyungpook National University Hospital | Daegu | |
Korea, Republic of | Yeungnam University Hospital | Daegu | |
Korea, Republic of | Hanyang Univerisy Guri Hospital | Guri-si | Gyeonggi-do |
Korea, Republic of | Chonnam National University Hospital | Gwangju | |
Korea, Republic of | Wonkwang University Hospital | Iksan-si | Jeollabuk-do |
Korea, Republic of | Gachon University Gil Medical Center | Incheon | |
Korea, Republic of | The Catholic University of Korea, Incheon St. Mary's Hospital | Incheon | |
Korea, Republic of | Chonbuk National University Hospital | Jeonju-si | Jeollabuk-do |
Korea, Republic of | Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do |
Korea, Republic of | Kangbuk Samsung Hospital | Seoul | |
Korea, Republic of | Korea University Anam Hospital | Seoul | |
Korea, Republic of | Severance Hospital, Yonsei University | Seoul | |
Korea, Republic of | The Catholic University of Korea, St. Vincent's Hospital | Suwon-si | Gyeonggi-do |
Korea, Republic of | Yonsei University Wonju Severance Christian Hospital | Wonju-si | Gangwon-do |
Philippines | Cebu Doctors University Hospital | Cebu City | |
Philippines | De La Salle University Medical Center | Dasmarinas City, Cavite | |
Philippines | Davao Doctors Hospital | Davao | |
Philippines | West Visayas State University Medical Center | Iloilo City | |
Philippines | Philippine General Hospital | Manila | |
Philippines | St. Luke's Medical Center Global City | Taguig City | |
Taiwan | China Medical University Hospital | Taichung | |
Taiwan | National Taiwan University Hospital | Taipei | |
Taiwan | Taipei Veterans General Hospital | Taipei | |
Taiwan | Tri-Service General Hospital | Taipei | |
Taiwan | Chang Gung Memorial Hospital, Linkou | Taoyuan County |
Lead Sponsor | Collaborator |
---|---|
Takeda |
China, Korea, Republic of, Philippines, Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | 4 weeks post treatment (up to approximately 12 weeks) | |
Secondary | 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. | Week 4 | |
Secondary | 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. | Week 2 up to Week 8 |
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