A Phase 3, Long-term Extension Study of TAK-438 (10 mg or 20 mg) for the Prevention of Recurrent Gastric or Duodenal Ulcers during Long-term Therapy of Low-dose Aspirin.
- Conditions
- Gastric or duodenal ulcers caused by low-dose aspirin
- Registration Number
- JPRN-jRCT2080221576
- Lead Sponsor
- TAKEDA PHARMACEUTICAL COMPANY LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 439
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)
etc.
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
etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of treatment-emergent adverse events<br>Treatment-emergent adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through the last visit.<br><br>Timeframe:28-80 weeks
- Secondary Outcome Measures
Name Time Method aboratory values, Electrocardiograms, Vital signs, Serum gastrin, Pepsinogen I and II, and Recurrence rate of gastric or duodenal ulcer<br>Timeframe:28-80 weeks