Efficacy and Safety of TAK-438 for the Prevention of Recurrent Gastric or Duodenal Ulcers During Therapy of Non-steroidal Anti-inflammatory Drug (NSAID)

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 non-steroidal anti-Inflammatory drug (NSAID).

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 Non-steroidal Anti-inflammatory Drug (NSAID).

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 NSAID 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 NSAID 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