A Unblinded Study of TAK-438 (20 mg) for Prevention of Recurrence of Gastric or Duodenal Ulcer During Long-Term Low-Dose Aspirin Therapy

Exclusion Criteria

• •1. Participants who received treatment with another study drug (including approved drugs under post-marketing surveillance) within 84 days prior to commencement of screening
• •2. Participants who have previously received TAK-438 in a clinical study or as a treatment
• •3. Participants who are employees of institutions participating in this study and family members of such employees, participants in a dependent relationship with employees of institutions involved in conduct of the study (e.g., spouse, parent, child, sibling), and participants who are under duress in giving their consent
• •4. Participant who have donated 400 mL or more of blood within 90 days prior to the commencement of screening
• •5. Participants with a plan to change the type, dosage or administration of low-dose aspirin.
• •6. Participants with ulcer (mucosal defects of 3 mm or larger with white moss) or active hemorrhage confirmed during gastric or duodenal endoscopy on the study drug initiation day (Visit 2)
• •7. Participants with small intestinal hemorrhage, large intestinal hemorrhage, or gastrointestinal hemorrhage of unknown cause
• •8. Participants with a history of surgery or scheduled surgery influencing gastric acid secretion (resection of upper gastrointestinal tract or vagotomy etc)
• •9. Participants with a history or complication of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders
• •10. Participants with a history or complication of aspirin asthma
• •11. Participants who have a history of hypersensitivity or allergy to TAK-438 (including its excipients) or aspirin or salicylic acid agents.
• •12. Participants with current use of illicit drug or a history of drug abuse. and/or alcohol dependence within one year prior to the commencement of screening
• •13. Participants who require treatment with prohibited concomitant drugs or therapies (see 7.3)
• •14. Female participants who are pregnant or lactating; those who plan to become pregnant or donate ova during treatment period, from giving consent until 4 weeks after final dose
• •15. Participants with serious central nervous system disorders, cardiovascular disease, pulmonary disease, hepatic disease, renal disease, metabolic disease, gastrointestinal disorders, urinary disorders, endocrine disease, or blood dyscrasia
• •16. Participants who plan to undergo surgery requiring hospitalization or requires surgery during the study period
• •17. Participants with a history of a malignancy (or treatment thereof) within 5 years prior to the commencement of screening; however, participants with completely cured of basal cell carcinoma of skin or carcinoma in situ of the cervix may be included in the study.
• •18. Participants with acquired immune deficiency syndrome (AIDS; including HIV carriers) or hepatitis (including viral hepatitis carriers \[HBs antigen positive or HCV antibody positive\]); however, Participants who are hepatitis C virus (HCV) antigen negative or HCV-RNA negative may be included in the study.
• •19. Participants who meet either of the following laboratory test values at the beginning of screening (Visit 1)
• •* Serum creatinine value: higher than 2 mg/dL
• •* Alanine transaminase (ALT) or aspartate aminotransferase (AST): higher than 2.5 × the upper limit of normal
• •* Total bilirubin: higher than 2.0 × the upper limit of normal