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

Takeda

Status and phase: Completed; Phase 3

Conditions: Gastric Ulcer

Treatments: Drug: Placebo; Drug: TAK-438; Drug: Lansoprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT01452711

U1111-1123-8551 (Registry Identifier)

TAK-438/CCT-101

JapicCTI-111612 (Registry Identifier)

Details and patient eligibility

About

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

Enrollment: 482 patients

Sex: All

Ages: 20+ years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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482 participants in 2 patient groups

TAK-438 20 mg QD

Experimental group

Treatment:

Drug: Placebo

Drug: Placebo

Drug: TAK-438

Lansoprazole 30 mg QD

Active Comparator group

Treatment:

Drug: Lansoprazole

Drug: Placebo

Drug: Placebo