Trials / Completed
CompletedNCT01505127
Efficacy of TAK-438, Amoxicillin and Clarithromycin in the First Line Eradication of H. Pylori
A Phase 3, Randomized, Double-Blind, Double Dummy, Multicenter, Parallel Group Comparison Study to Evaluate Efficacy and Safety of a Triple Therapy With TAK-438, Amoxicillin and Clarithromycin by Comparison With a Triple Therapy With AG-1749 (Lansoprazole), Amoxicillin and Clarithromycin for the First Line Eradication of H.Pylori
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 650 (actual)
- Sponsor
- Takeda · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
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 Lansoprazole, Amoxicillin and Clarithromycin in H. pylori-positive patients with scarred gastric or duodenal ulcers.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TAK-438 | |
| DRUG | Lansoprazole | |
| DRUG | Amoxicillin | |
| DRUG | Clarithromycin |
Timeline
- Start date
- 2012-01-01
- Primary completion
- 2013-06-01
- Completion
- 2013-06-01
- First posted
- 2012-01-06
- Last updated
- 2013-11-05
Locations
35 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT01505127. Inclusion in this directory is not an endorsement.