Efficacy of TAK-438 Compared to AG-1749 (Lansoprazole) in the Treatment of Gastric 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 Gastric Ulcer.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01452711

Enrollment

482

Registered

2011-10-17

Start date

2011-11-30

Completion date

2012-12-31

Last updated

2013-06-21

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

Conditions

Gastric Ulcer

Keywords

Drug Therapy

Brief summary

The purpose of this study is to investigate the efficacy of TAK-438, once daily (QD), compared to lansoprazole in patients with gastric ulcer.

Interventions

DRUGTAK-438

TAK-438 20 mg, tablets, orally, once daily for up to 8 weeks.

DRUGPlacebo

Lansoprazole placebo-matching capsules, orally, once daily for up to 8 weeks.

DRUGLansoprazole

Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Participants must have endoscopically confirmed gastric 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

1. Participants with a gastric ulcer which is suspected to be malignant on endoscopy at baseline (Visit 1) 2. Participants with an Acute Gastric Mucosal Lesion (AGML) 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 duodenal 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	Description
Endoscopic Healing Rate of Gastric Ulcer Over 8 weeks	8 weeks	Endoscopic healing rate : Rate of participants who have endoscopically confirmed all of the white coatings disappeared.

Secondary

Measure	Time frame
Change from Baseline in the Incidence of Gastrointestinal Symptoms Associated with Gastric Ulcer	Baseline and 8 weeks
Endoscopic healing Rates of Gastric Ulcer on Endoscopy over 4 weeks	4 weeks
Endoscopic healing Rates of Gastric Ulcer on Endoscopy at week 2	2 weeks

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026