Efficacy and Safety of TAK-438 for the Prevention of Recurrent Gastric or Duodenal Ulcers During 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

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01452763

Enrollment

621

Registered

2011-10-17

Start date

2011-10-31

Completion date

2013-04-30

Last updated

2014-01-20

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

Conditions

Duodenal Ulcers, Gastric Ulcers

Keywords

Drug Therapy

Brief summary

The purpose of this study is to evaluate the efficacy of TAK-438, once daily (QD) compared to AG-1749 (Lansoprazole) in patients with a history of gastric or duodenal ulcer who require long-term therapy of low-dose aspirin.

Interventions

DRUGTAK-438

TAK-438 10 mg tablets, orally, once daily for up to 24 weeks.

DRUGPlacebo

Lansoprazole placebo-matching capsules, orally, once daily for up to 24 weeks.

DRUGLansoprazole

Lansoprazole 15 mg capsules, orally, once daily for up to 24 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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)

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

Design outcomes

Primary

Measure	Time frame	Description
Recurrence rate of gastric or duodenal ulcer within 24 weeks	24 weeks	Mucosal defects with a white coating of 3 mm or larger will be determined as ulcers. Recurrence rate of gastric or duodenal ulcer within 24 weeks will be calculated for each treatment group.

Secondary

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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026