Long-term Extension Study of TAK-438 for the Prevention of Recurrent Gastric or Duodenal Ulcers During Therapy of Non-steroidal Anti-inflammatory Drug (NSAID)

• Status: Completed
• Trial end date: 2013-12-01
• 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 non-steroidal anti-inflammatory drug (NSAID) therapy in patients with a history of gastric or duodenal ulcer who require long-term therapy of NSAID.

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

Details

• Lead Sponsor: Takeda
• Treatments: Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal; Dexlansoprazole; Lansoprazole

Criteria

Inclusion Criteria:

1. Participants who require continuous NSAID 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 NSAID

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