Duodenal Ulcer
Conditions
Keywords
Drug Therapy
Brief summary
The purpose of this study is to determine the efficacy of TAK-438, once daily (QD), compared to lansoprazole in patients with duodenal ulcer.
Interventions
DRUGTAK-438
TAK-438 20 mg, tablets, orally, once daily for up to 6 weeks.
DRUGPlacebo
Lansoprazole placebo-matching capsules, orally, once daily for up to 6 weeks.
DRUGLansoprazole
Lansoprazole 30 mg, capsules, orally, once daily for up to 6 weeks.
Sponsors
Takeda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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)
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endoscopic Healing Rate of Duodenal Ulcer Over 6 Weeks | 6 weeks | Endoscopic healing rate : Rate of participants who have endoscopically confirmed all of the white coatings disappeared. |
Secondary
| Measure | Time frame |
|---|---|
| Endoscopic healing Rates of Duodenal Ulcer on Endoscopy over 4 weeks | 4 weeks |
| Endoscopic healing Rates of Gastric Ulcer on Endoscopy at week 2 | 2 weeks |
| Change from Baseline in the Incidence of Gastrointestinal Symptoms Associated with Duodenal Ulcer | Baseline and 6 weeks |
Countries
Japan
Outcome results
None listed