A Phase 3, Double-Blind Study of TAK-438 (20 mg) in the Treatment of Duodenal Ulcer
- Conditions
- Duodenal Ulcer
- Registration Number
- JPRN-jRCT2080221568
- Lead Sponsor
- TAKEDA PHARMACEUTICAL COMPANY LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 390
1. Participants must have endoscopically confirmed duodenal ulcers (mucosal defect with white coating).At least one ulcer with white coating of 5 mm or larger in size should be observed at baseline (Visit 1).
2. Outpatient (including short inpatient for examination and others)
1. Participants with a gastric ulcer which is suspected to be malignant on endoscopy at baseline (Visit 1)
2. Participants with an Acute Duodenal Mucosal Lesion (ADML) on endoscopy at baseline (Visit 1)
3. Participants with a linear ulcer (including scarring) on endoscopy at baseline (Visit 1)
4. Participants with a postoperative ulcer (e.g., Ulcer after EMR/ESD) on endoscopy at baseline (Visit 1)
5. Participants with a gastric ulcer on endoscopy at baseline (Visit 1)
6. Participants with an ulcer for which medical treatment is not indicated (e.g., perforation, pyloric stenosis,duodenal stenosis, large hemorrhage)
7. Participants who have received endoscopic hemostasis for gastric ulcer within 30 days prior to baseline (Visit 1)
8. Participants with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders
9. Participants who have received or who are scheduled to undergo surgery which affects gastric acid secretion (e.g., resection of upper gastrointestinal tract, vagotomy)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Endoscopic healing rate of duodenal ulcer over 6 weeks<br>Endoscopic healing rate : Rate of participants who have endoscopically comfirmed all of the white coatings disappeared.<br><br>Timeframe: 6 weeks
- Secondary Outcome Measures
Name Time Method Endoscopic Healing Rate of Duodenal Ulcer at Week 2 <br>Timeframe: 2 Weeks<br>Endoscopic Healing Rate of Duodenal Ulcer over 4 weeks<br>Timeframe: 4 weeks<br>Change from Baseline in the Incidence of Gastrointestinal Symptoms Associated with Duodenal Ulcer<br>Timeframe: 8 weeks