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

Phase 3

Completed

• Conditions: Gastric Ulcers; Duodenal Ulcers
• Interventions: Drug: TAK-438; Drug: Lansoprazole; Drug: Placebo

• Registration Number: NCT01452763
• Lead Sponsor: Takeda

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-09-16
• Study Start: 2011-10
• Study First Submitted QC: 2011-10-14
• Study First Posted: 2011-10-17
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-17
• Last Update Posted: 2014-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 621

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAK-438 10 mg QD	Placebo	-
TAK-438 20 mg QD	Placebo	-
Lansoprazole 15 mg QD	Placebo	-
TAK-438 10 mg QD	TAK-438	-
TAK-438 20 mg QD	TAK-438	-
Lansoprazole 15 mg QD	Lansoprazole	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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