Long-term Extension Study of TAK-438 for the Prevention of Recurrent Gastric or Duodenal Ulcers During 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

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01456247

Enrollment

439

Registered

2011-10-20

Start date

2012-03-31

Completion date

2013-10-31

Last updated

2014-05-08

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 safety of TAK-438, once daily (QD), during long-term concomitant low-dose aspirin therapy 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 28-80 weeks.

DRUGPlacebo

Lansoprazole placebo-matching capsules, orally, once daily for 28-80 weeks.

DRUGLansoprazole

Lansoprazole 15 mg capsules, orally, once daily for 28-80 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

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

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

Design outcomes

Primary

Measure	Time frame	Description
Incidence of treatment-emergent adverse events	Up to 80 weeks.	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 of study.

Secondary

Measure	Time frame
Change from baseline in Electrocardiograms	Up to 80 weeks.
Change from baseline in Vital signs	Up to 80 weeks.
Change from baseline in Laboratory values	Up to 80 weeks.
Change from baseline in Pepsinogen I and II	Up to 80 weeks.
Recurrence rate of gastric or duodenal ulcer	Up to 80 weeks.
Change from baseline in Serum gastrin	Up to 80 weeks.

Countries

Japan

Outcome results

None listed

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