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

Phase 3

Completed

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

• Registration Number: NCT01452724
• Lead Sponsor: Takeda

Brief Summary

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

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: 2013-02
• Study Completion: 2013-02
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-19
• Last Update Posted: 2013-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 372

Inclusion Criteria

1. 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).
2. Outpatient (including short inpatient for examination and others)

Exclusion Criteria

1. Participants with a gastric ulcer which is suspected to be malignant on endoscopy at baseline (Visit 1)
2. Participants with an Acute Duodenal Mucosal Lesion (ADML) on endoscopy at baseline (Visit 1)
3. Participants with a linear ulcer (including scarring) on endoscopy at baseline (Visit 1)
4. Participants with a postoperative ulcer (e.g., Ulcer after EMR/ESD) on endoscopy at baseline (Visit 1)
5. Participants with a gastric ulcer on endoscopy at baseline (Visit 1)
6. Participants with an ulcer for which medical treatment is not indicated (e.g.,perforation, pyloric stenosis, duodenal stenosis, large hemorrhage)
7. Participants who have received endoscopic hemostasis for gastric ulcer within 30 days prior to baseline (Visit 1)
8. Participants with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders
9. Participants who have received or who are scheduled to undergo surgery which affects gastric acid secretion (e.g., resection of upper gastrointestinal tract, vagotomy)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAK-438 20 mg QD	Placebo	-
Lansoprazole 30 mg QD	Lansoprazole	-
Lansoprazole 30 mg QD	Placebo	-
TAK-438 20 mg QD	TAK-438	-

Primary Outcome Measures

Name	Time	Method
Endoscopic Healing Rate of Duodenal Ulcer Over 6 Weeks	6 weeks	Endoscopic healing rate : Rate of participants who have endoscopically confirmed all of the white coatings disappeared.

Secondary Outcome Measures

Name	Time	Method
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