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.

A Phase 3, Multicenter, Single-blind, AG-1749-controlled, Parallel-group, Long-term Extension Study to Evaluate the Safety and Efficacy 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-jRCT2080221576

Enrollment

439

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 completed the preceding study 3. Outpatient (including inpatient for examinations) etc.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Incidence of treatment-emergent adverse events 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. Timeframe:28-80 weeks	—

Secondary

Measure	Time frame
Laboratory values, Electrocardiograms, Vital signs, Serum gastrin, Pepsinogen I and II, and Recurrence rate of gastric or duodenal ulcer Timeframe:28-80 weeks	—

Outcome results

None listed

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