Long-term Extension Study 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 safety of TAK-438, once daily (QD), during long-term concomitant non-steroidal anti-inflammatory drug (NSAID) therapy in patients with a history of gastric or duodenal ulcer who require long-term therapy of NSAID.

Official Title
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A Phase 3, Multicenter, Single-blind, AG-1749-controlled, Parallel-group, Long-term Extension Study to Evaluate the Safety and Efficacy 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 completed the preceding study Outpatient (including inpatient for examinations) Exclusion Criteria: Participants deemed to be ineligible to participate in the study by the principal investigator or investigator due to the occurrence of adverse events in the preceding study Participants who are scheduled to change the type and dosage regimen of NSAID Participants with ulcers or bleeding in stomach or duodenum, endoscopically confirmed during the preceding study 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: Single


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 28-80 weeks.<br>Drug: Placebo<br>* Lansoprazole placebo matching capsules, orally, once daily for 28-80 weeks.<br>|
| Experimental: TAK-438 20 mg QD<br> | Drug: TAK-438<br>* TAK-438 20 mg tablets, orally, once daily for 28-80 weeks.<br>Drug: Placebo<br>* Lansoprazole placebo-matching capsules, orally, once daily for 28-80 weeks.<br>|
| Active Comparator: Lansoprazole 15 mg QD<br> | Drug: Lansoprazole<br>* Lansoprazole 15 mg capsules, orally, once daily for 28-80 weeks.<br>* Other names: AG-1749;Drug: Placebo<br>* TAK-438 placebo-matching tablets, orally, once daily for 28-80 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment-emergent adverse events | Treatment-emergent adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through the last visit of study. | Up to 80 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Laboratory values |  | Up to 80 weeks. | 
| Change from baseline in Electrocardiograms |  | Up to 80 weeks. | 
| Change from baseline in Vital signs |  | Up to 80 weeks. | 
| Change from baseline in Serum gastrin |  | Up to 80 weeks. | 
| Change from baseline in Pepsinogen I and II |  | Up to 80 weeks. | 
| Recurrence rate of gastric or duodenal ulcer |  | Up to 80 weeks. | 

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