Status:
COMPLETED
Efficacy and Safety of TAK-438 Compared to AG-1749 (Lansoprazole) in the Treatment of Duodenal Ulcer
Lead Sponsor:
Takeda
Conditions:
Duodenal Ulcer
Eligibility:
All Genders
20+ years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
372 Patients enrolled
Trial Details
Trial ID
NCT01452724
Start Date
October 1 2011
End Date
February 1 2013
Last Update
August 20 2013
Active Locations (64)
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1
Toyota-shi, Aichi-ken, Japan
2
Kamagaya-shi, Chiba, Japan
3
Kisarazu-shi, Chiba, Japan
4
Fukui-shi, Fukui, Japan