Efficacy and Safety of TAK-438 for the Prevention of Recurrent Gastric or Duodenal Ulcers During Therapy of Non-steroidal Anti-inflammatory Drug (NSAID)

• Recurrence rate of gastric or duodenal ulcer within 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
• Gastric mucosal injury [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
• Duodenal mucosal injury [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
• Occurrence rate of hemorrhagic lesion in stomach or duodenum [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
• Time to recurrence of gastric or duodenal ulcer [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

The purpose of this study is to evaluate the efficacy of TAK-438, once daily (QD), compared to AG-1749 (Lansoprazole) in patients with a history of gastric or duodenal ulcer who require long-term therapy of non-steroidal anti-Inflammatory drug (NSAID).

• Gastric Ulcers
• Duodenal Ulcers

• Drug: TAK-438
  TAK-438 10 mg tablets, orally, once daily for up to 24 weeks.
• Drug: Placebo
  Lansoprazole placebo-matching capsules, orally, once daily for up to 24 weeks.
• Drug: TAK-438
  TAK-438 20 mg tablets, orally, once daily for up to 24 weeks.
• Drug: Lansoprazole
  Lansoprazole 15 mg capsules, orally, once daily for up to 24 weeks.
  Other Name: AG-1749
• Drug: Placebo
  TAK-438 placebo-matching tablets, orally, once daily for up to 24 weeks.

• Experimental: TAK-438 10 mg QD
  Interventions:

  • Drug: TAK-438
  • Drug: Placebo
• Experimental: TAK-438 20 mg QD
  Interventions:

  • Drug: TAK-438
  • Drug: Placebo
• Active Comparator: Lansoprazole 15 mg QD
  Interventions:

  • Drug: Lansoprazole
  • Drug: Placebo

Inclusion Criteria:

1. Participants who require continuous NSAID therapy during the treatment period with the study drug
2. Participants who have a history of ulcer in stomach or duodenum, endoscopically confirmed
3. Outpatient (including inpatient for examinations)

Exclusion Criteria:

1. Participants scheduled to change the type and dosage regimen of NSAID
2. Participants with ulcers or bleeding in stomach or duodenum, endoscopically confirmed
3. Participants with small intestine bleeding, large intestine bleeding, or gastrointestinal bleeding of unknown etiology
4. Participants who have a history of surgery which affects gastric acid secretion (e.g., resection of upper gastrointestinal tract, vagotomy) or who are scheduled to undergo such surgery
5. Participants with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders
6. Participants with a previous or current history of aspirin-induced asthma