drugset / Trial / NCT01456260

Long-term Extension Study of TAK-438 for the Prevention of Recurrent Gastric or Duodenal Ulcers During Therapy of Non-steroidal Anti-inflammatory Drug (NSAID)

NCT01456260

Phase 3 Completed 406 enrolled Takeda
RandomizedParallel-groupSingle-blindPrevention

Summary

The purpose of this study is to evaluate the safety of TAK-438, once daily (QD), during long-term concomitant non-steroidal anti-inflammatory drug (NSAID) therapy in patients with a history of gastric or duodenal ulcer who require long-term therapy of NSAID.

Timeline

Start
2011-09
Primary completion
Completion
2013-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Lansoprazole Other / unclassified 15 mg Oral
Subject Vonoprazan Other / unclassified 10 mg Oral
Subject Vonoprazan Other / unclassified 20 mg Oral