A Phase 3, Double-blind, Comparison 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.

A Phase 3, Multicenter, Randomized, Double-blind, AG-1749-controlled, Parallel-group, Comparison Study to Evaluate the Efficacy and Safety of TAK-438 (10 mg or 20 mg, Orally, Once Daily) for the Prevention of Recurrent Gastric or Duodenal Ulcers during Long-term Therapy of Low-dose Aspirin.

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221570

Enrollment

630

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

Gastric or duodenal ulcers caused by low-dose aspirin

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 who require continuous low-dose aspirin therapy during the treatment period with the study drug 2. Participants who have a history of ulcer in stomach or duodenum, endoscopically confirmed 3. Outpatient (including inpatient for examinations) etc.

Exclusion criteria

Exclusion criteria: 1. Participants scheduled to change the type and dosage regimen of low-dose aspirin 2. Participants with ulcers or bleeding in stomach or duodenum, endoscopically confirmed 3. Participants with small intestine bleeding, large intestine bleeding, or gastrointestinal bleeding of unknown etiology 4. 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 5. Participants with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders 6. Participants with a previous or current history of aspirin-induced asthma etc.

Design outcomes

Primary

Measure	Time frame
Recurrence rate of gastric or duodenal ulcer within 24 weeks Mucosal defects with a white coating of 3 mm or larger will be determined as ulcers Timeframe: 24 weeks	—

Secondary

Measure	Time frame
Recurrence rate of gastric or duodenal ulcer within 12 weeks, Gastric mucosal injury, Duodenal mucosal injury, Occurrence rate of hemorrhagic lesion in stomach or duodenum, Time to recurrence of gastric or duodenal ulcer Timeframe: 12 weeks, 24 weeks	—

Outcome results

None listed

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