Status:
COMPLETED
Efficacy of TAK-438, Amoxicillin and Clarithromycin in the First Line Eradication of H. Pylori
Lead Sponsor:
Takeda
Conditions:
H. Pylori Infection
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to confirm the efficacy of triple therapy with TAK-438, Amoxicillin and Clarithromycin, twice daily (BID) by demonstrating its non-inferiority to triple therapy with Lanso...
Eligibility Criteria
Inclusion
- Participants must be H. pylori-positive patients at baseline (Visit 1)
- Participants must be endoscopically confirmed to have scarred gastric ulcer or duodenal ulcer at baseline (Visit 1).
- However, if a history of ulcers is confirmed by the medical interview or previous medical record, Participants whose gastric ulcer scar or duodenal ulcer scar has disappeared may be included in the study.
- Outpatient (including inpatient for examination)
Exclusion
- Participants who have received H.pylori eradication treatment
- Participants who have either acute upper gastrointestinal bleeding, gastric ulcer \[mucosal defect (with white coating including clot adherence) of 3 mm or larger in size\], duodenal ulcer \[mucosal defect (with white coating including clot adherence) of 3 mm or larger in size\], acute gastric mucosal lesion (AGML), or acute duodenal mucosal lesion (ADML) on endoscopic examination at baseline (Visit 1).
- However, participants with gastric erosion or duodenal erosion may be included in the study.
- Participants who have received or who are scheduled to undergo surgery which affects gastric acid secretion (ex, resection of upper gastrointestinal tract, vagotomy, etc)
- Participants who cannot be treated with medicinal treatment (ex, perforation, pyloric stenosis or large hemorrhage, etc)
- Participants with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders
- Participants with hepatic or renal impairment receiving treatment with colchicines
- Participants who have a history of hypersensitivity or allergy to TAK-438 (including its excipients), PPIs, penicillin antibiotics, macrolide antibiotics, or antitrichomonal agents
- Participants with infectious mononucleosis
- Participants with an organic disease of the brain or spinal cord
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
650 Patients enrolled
Trial Details
Trial ID
NCT01505127
Start Date
January 1 2012
End Date
June 1 2013
Last Update
November 5 2013
Active Locations (35)
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1
Abiko-shi, Chiba, Japan
2
Kashiwa-shi, Chiba, Japan
3
Fukui-shi, Fukui, Japan
4
Fukuoka, Fukuoka, Japan