Long-term Extension Study of TAK-438 for the Prevention of Recurrent Gastric or Duodenal Ulcers During Therapy of Low-dose Aspirin

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety of TAK-438, once daily (QD), during long-term concomitant low-dose aspirin therapy in patients with a history of gastric or duodenal ulcer who require long-term therapy of low-dose aspirin.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Takeda
• Treatments: Aspirin; Dexlansoprazole; Lansoprazole

Criteria

Inclusion Criteria:

1. Participants who require continuous low-dose aspirin therapy during the treatment period with the study drug

2. Participants who have completed the preceding study

3. Outpatient (including inpatient for examinations)

Exclusion Criteria:

1. Participants deemed to be ineligible to participate in the study by the principal investigator or investigator due to the occurrence of adverse events in the preceding study

2. Participants who are scheduled to change the type and dosage regimen of low-dose aspirin

3. Participants with ulcers or bleeding in stomach or duodenum, endoscopically confirmed during the preceding study

4. Participants with small intestine bleeding, large intestine bleeding, or gastrointestinal bleeding of unknown etiology

5. 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

6. Participants with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders

7. Participants with a previous or current history of aspirin-induced asthma