Trials / Completed
CompletedNCT01452776
Long-Term Safety Study of TAK-438 in the Maintenance Treatment of Healed Erosive Esophagitis
A Phase 3, Randomized, Single-Blind, Multicenter Study to Evaluate the Safety of TAK-438 (10 and 20 mg Once-daily) in a 52-week Maintenance Treatment in Patients With Healed Erosive Esophagitis (EE)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 305 (actual)
- Sponsor
- Takeda · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine the safety of long term use of TAK-438, once daily (QD), for the maintenance treatment of healed erosive esophagitis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TAK-438 | TAK-438 10 mg, tablets, orally, once daily for up to 52 weeks. |
| DRUG | TAK-438 | TAK-438 20 mg, tablets, orally, once daily for up to 52 weeks. |
Timeline
- Start date
- 2011-09-01
- Primary completion
- 2013-07-01
- Completion
- 2013-07-01
- First posted
- 2011-10-17
- Last updated
- 2013-11-05
Locations
32 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT01452776. Inclusion in this directory is not an endorsement.