Trials / Completed
CompletedNCT01452711
Efficacy of TAK-438 Compared to AG-1749 (Lansoprazole) in the Treatment of Gastric Ulcer
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 Gastric Ulcer.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 482 (actual)
- Sponsor
- Takeda · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to investigate the efficacy of TAK-438, once daily (QD), compared to lansoprazole in patients with gastric ulcer.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TAK-438 | TAK-438 20 mg, tablets, orally, once daily for up to 8 weeks. |
| DRUG | Placebo | Lansoprazole placebo-matching capsules, orally, once daily for up to 8 weeks. |
| DRUG | Lansoprazole | Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks. |
| DRUG | Placebo | TAK-438 placebo-matching tablets, orally, once daily for up to 8 weeks. |
Timeline
- Start date
- 2011-11-01
- Primary completion
- 2012-12-01
- Completion
- 2012-12-01
- First posted
- 2011-10-17
- Last updated
- 2013-06-21
Locations
64 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT01452711. Inclusion in this directory is not an endorsement.