TAK-438
DrugTAK-438 20 mg, tablets, orally, once daily for up to 8 weeks.
NCT Number: NCT01452698
The purpose of this study is to determine the efficacy of TAK-438, once daily (QD), compared to lansoprazole in patients with erosive esophagitis of Grade A to D as defined by the LA classification grading system.
Looking for future studies?
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 20 mg, tablets, orally, once daily for up to 8 weeks.
Lansoprazole placebo-matching capsules, orally, once daily for up to 8 weeks.
For participants whose EE is not endoscopically healed at Week 8, the participants will receive additional treatment of TAK-438 40 mg, tablets, orally, once daily for up to an additional 8 weeks.
Other names: AG-1749
Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
For participants whose EE is not endoscopically healed at Week 8, the participants will receive additional treatment of TAK-438 40 mg, tablets, orally, once daily for up to an additional 8 weeks.
Other names: AG-1749
Time frame: 8 Weeks
Endoscopic healing of erosive esophagitis is defined as those participants who have endoscopically confirmed EE of Grade O as defined by the Los Angeles (LA) Classification Grading System. The definitions of each grade are: Grade O (No mucosal break), Grade A (Mucosal break <5 mm), Grade B (Mucosal break ≥5 mm), Grade C (Mucosal break continuous between two or more folds and <75% of the circumference) and Grade D (Mucosal break ≥75% of the circumference).
Time frame: 2 Weeks
Time frame: 4 Weeks
Takeda
Industry
A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of TAK-438 (20 mg Once-Daily) Compared to AG-1749 (30mg Once-Daily) in Patients With Erosive Esophagitis
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.
Published trials that share one or more normalized conditions with this study.
NCT05055128
Erosive Esophagitis
Tampa, Florida, United States
View Trial DetailsNCT05587309
Erosive Esophagitis
Homewood, Alabama, United States
View Trial DetailsNCT05890001
Deglutition Disorders, Digestive System Diseases
Huntsville, Alabama, United States
View Trial DetailsNCT06391177
Erosive Esophagitis, Heartburn
Las Vegas, Nevada, United States
View Trial Details