A Phase 3, Double-Blind Study of TAK-438 (20 mg) in the Treatment of Duodenal Ulcer

A Phase 3, Randomized, Double Blind, Double-Dummy, Multicenter, Parallel Group Comparison Study to on Efficacy and Safety of Oral Once-Daily Administration of TAK-438 20 mg comparing with AG-1749 in patients with Duodenal Ulcer

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221568

Enrollment

390

Registered

2011-09-07

Start date

2011-09-07

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Duodenal Ulcer

Interventions

investigational material(s) Generic name etc : TAK-438 INN of investigational material : Therapeutic category code : 232 Agents for peptic ulcer Dosage and Administration for Investigational material

Eligibility

Sex/Gender

All

Inclusion criteria

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

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
Endoscopic healing rate of duodenal ulcer over 6 weeks Endoscopic healing rate : Rate of participants who have endoscopically comfirmed all of the white coatings disappeared. Timeframe: 6 weeks	—

Secondary

Measure	Time frame
Endoscopic Healing Rate of Duodenal Ulcer at Week 2 Timeframe: 2 Weeks Endoscopic Healing Rate of Duodenal Ulcer over 4 weeks Timeframe: 4 weeks Change from Baseline in the Incidence of Gastrointestinal Symptoms Associated with Duodenal Ulcer Timeframe: 8 weeks	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026