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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Gastric Ulcers, Duodenal Ulcers

Intervention / Treatment
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* Drug: TAK-438
* Drug: Placebo
* Drug: TAK-438
* Drug: Placebo
* Drug: Lansoprazole
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants who require continuous low-dose aspirin therapy during the treatment period with the study drug Participants who have a history of ulcer in stomach or duodenum, endoscopically confirmed Outpatient (including inpatient for examinations) Exclusion Criteria: Participants scheduled to change the type and dosage regimen of low-dose aspirin Participants with ulcers or bleeding in stomach or duodenum, endoscopically confirmed Participants with small intestine bleeding, large intestine bleeding, or gastrointestinal bleeding of unknown etiology 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 Participants with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders Participants with a previous or current history of aspirin-induced asthma

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAK-438 10 mg QD<br> | Drug: TAK-438<br>* TAK-438 10 mg tablets, orally, once daily for up to 24 weeks.<br>Drug: Placebo<br>* Lansoprazole placebo-matching capsules, orally, once daily for up to 24 weeks.<br>|
| Experimental: TAK-438 20 mg QD<br> | Drug: TAK-438<br>* TAK-438 20 mg tablets, orally, once daily for up to 24 weeks.<br>Drug: Placebo<br>* Lansoprazole placebo-matching capsules, orally, once daily for up to 24 weeks.<br>|
| Active Comparator: Lansoprazole 15 mg QD<br> | Drug: Lansoprazole<br>* Lansoprazole 15 mg capsules, orally, once daily for up to 24 weeks.<br>* Other names: AG-1749;Drug: Placebo<br>* TAK-438 placebo-matching tablets, orally, once daily for up to 24 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence rate of gastric or duodenal ulcer within 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. | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug Therapy