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

Study Overview
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Brief Summary
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The purpose of this study is to determine the efficacy of TAK-438, once daily (QD), compared to lansoprazole in patients with duodenal ulcer.

Official Title
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A Phase 3, Randomized, Double Blind, Double-Dummy, Multicenter, Parallel Group Comparison Study to on Efficacy and Safety of Oral Once-Daily Administration of TAK-438 20 mg Comparing With AG-1749 in Patients With Duodenal Ulcer

Conditions
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Duodenal Ulcer

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must have endoscopically confirmed duodenal 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). Outpatient (including short inpatient for examination and others) Exclusion Criteria: Participants with a gastric ulcer which is suspected to be malignant on endoscopy at baseline (Visit 1) Participants with an Acute Duodenal Mucosal Lesion (ADML) on endoscopy at baseline (Visit 1) Participants with a linear ulcer (including scarring) on endoscopy at baseline (Visit 1) Participants with a postoperative ulcer (e.g., Ulcer after EMR/ESD) on endoscopy at baseline (Visit 1) Participants with a gastric ulcer on endoscopy at baseline (Visit 1) Participants with an ulcer for which medical treatment is not indicated (e.g.,perforation, pyloric stenosis, duodenal stenosis, large hemorrhage) Participants who have received endoscopic hemostasis for gastric ulcer within 30 days prior to baseline (Visit 1) Participants with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders Participants who have received or who are scheduled to undergo surgery which affects gastric acid secretion (e.g., resection of upper gastrointestinal tract, vagotomy)

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAK-438 20 mg QD<br> | Drug: TAK-438<br>* TAK-438 20 mg, tablets, orally, once daily for up to 6 weeks.<br>Drug: Placebo<br>* Lansoprazole placebo-matching capsules, orally, once daily for up to 6 weeks.<br>|
| Active Comparator: Lansoprazole 30 mg QD<br> | Drug: Lansoprazole<br>* Lansoprazole 30 mg, capsules, orally, once daily for up to 6 weeks.<br>* Other names: AG-1749;Drug: Placebo<br>* TAK-438 placebo-matching tablets, orally, once daily for up to 6 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endoscopic Healing Rate of Duodenal Ulcer Over 6 Weeks | Endoscopic healing rate : Rate of participants who have endoscopically confirmed all of the white coatings disappeared. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endoscopic healing Rates of Duodenal Ulcer on Endoscopy over 4 weeks |  | 4 weeks | 
| Endoscopic healing Rates of Gastric Ulcer on Endoscopy at week 2 |  | 2 weeks | 
| Change from Baseline in the Incidence of Gastrointestinal Symptoms Associated with Duodenal Ulcer |  | Baseline and 6 weeks | 

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