Comparison of TAK-438 (Vonoprazan) to Lansoprazole in the Treatment of Duodenal Ulcer Participants With or Without Helicobacter Pylori Infection
Condition: Duodenal Ulcer
MeSH terms: Duodenal Ulcer; Ulcer
Intervention: TAK-438; Lansoprazole; TAK-438 Placebo; Lansoprazole Placebo; Bismuth-Containing Quadruple Therapy
Intervention description: TAK-438 tablets; Lansoprazole capsules; TAK-438 placebo-matching tablets.; Lansoprazole placebo-matching capsules; 1 g Amoxicillin, 500 mg clarithromycin and 600 mg bismuth potassium citrate/bismuth tripotassium dicitrate, twice daily (BID).
Intervention MeSH terms: Lansoprazole; Dexlansoprazole; Bismuth
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 533.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Drug therapy; Gastrointestinal Diseases; Digestive System Diseases; Lansoprazole; Anti-Ulcer Agents; Gastrointestinal Agents; Proton Pump Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action

Summary:

      The purpose of this study is to demonstrate the non-inferior efficacy of TAK-438 versus
      lansoprazole in the treatment of participants with duodenal ulcer.
    

Eligibility criteria:

        Inclusion Criteria:

        1. Has endoscopic evidence of active duodenal ulcer(s) (i.e., mucosal defects with white
        coating [including cases associated with blood coagulation 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 a diagnosis of duodenal malignancy or a duodenal ulcer whose morphology suggested
             malignancy as evident by endoscopy within 14 days prior to randomization.

          5. Is suspected of having acute gastro-duodenal mucosal lesions (AGDML) as evident by
             endoscopy within 14 days prior to randomization.

          6. Has a linear ulcer (including a linear ulcer scar) that has been confirmed as evident
             by endoscopy within 14 days prior to randomization.

          7. Has active postoperative (eg, endoscopic mucosal resection / endoscopic submucosal
             dissection) ulcer(s) as confirmed by endoscopy within 14 days prior to randomization.

          8. Has gastric ulcer that has been confirmed by endoscopy within 14 days prior to
             randomization.

          9. Has ulcers for which medical therapy alone is not indicated (eg, perforation, pyloric
             stenosis, duodenal stenosis, major bleeding).

         10. Has undergone therapeutic upper gastrointestinal (GI) endoscopic therapy (eg,
             endoscopic hemostasis or excision including biopsy) within 30 days prior to visit 1.

         11. Has Zollinger-Ellison syndrome or gastric acid hypersecretion or those with a history
             of gastric acid hypersecretion.

         12. 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 (eg,
             abdominal surgery, vagotomy or craniotomy).

         13. 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).

         14. Has a known acquired immunodeficiency syndrome (AIDS) 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).

         15. 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).

         16. 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).