drugset / Trial / NCT01452711

Efficacy of TAK-438 Compared to AG-1749 (Lansoprazole) in the Treatment of Gastric Ulcer

NCT01452711 ↗

Phase 3 Completed 482 enrolled Takeda
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2011-11
Primary completion
2012-12
Completion
2012-12

Outcome

Met primary endpoint

paper non-inferiority of vonoprazan to lansoprazole was confirmed [difference = -0.3% (95% CI -4.750, 4.208); P = 0.0011]. PMID 27891632 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Lansoprazole Other / unclassified 30 mg Oral
Subject Vonoprazan Other / unclassified 20 mg Oral

Indications