TAK-438
DrugTAK-438 10 mg, tablets, orally, once daily for up to 52 weeks.
NCT Number: NCT01452776
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.
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Notify Me20 year and older
All sexes
Interventional
Phase 3
Nagoya, Aichi-ken, Japan
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
TAK-438 10 mg, tablets, orally, once daily for up to 52 weeks.
Time frame: 52 Weeks
Treatment-emergent adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through the last visit.
Time frame: Baseline and Week 52
Time frame: Baseline and Week 52
Time frame: Baseline and Week 52
Time frame: Baseline and Week 52
Time frame: Baseline and Week 52
Time frame: 52 Weeks
Takeda
Industry
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)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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