A Phase 3 interventional study of TAK-438 and Placebo in Gastric Ulcers and Duodenal Ulcers, sponsored by Takeda. Completed at 102 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2014-02-05.
Sponsored by Takeda · Phase 3, Interventional, and Prevention
The purpose of this study is to evaluate the efficacy of TAK-438, once daily (QD), compared to AG-1749 (Lansoprazole) in patients with a history of gastric or duodenal ulcer who require long-term therapy of non-steroidal anti-Inflammatory drug (NSAID).
112 studies on the registry are indexed under Stomach Ulcer; 13 are open to participants now.
This study's enrollment of 642 is above the median of 265 across 86 interventional studies indexed under Stomach Ulcer.
Browse Stomach Ulcer studies →Takeda is the lead sponsor of 1,002 studies on the registry; 92 are open to participants now.
Of its 173 completed or terminated interventional studies of FDA-regulated products, 149 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: TAK-438 · Drug: Placebo
Drug: TAK-438 · Drug: Placebo
Drug: Lansoprazole · Drug: Placebo
TAK-438 10 mg tablets, orally, once daily for up to 24 weeks.
Lansoprazole placebo-matching capsules, orally, once daily for up to 24 weeks.
TAK-438 20 mg tablets, orally, once daily for up to 24 weeks.
Lansoprazole placebo-matching capsules, orally, once daily for up to 24 weeks.
Lansoprazole 15 mg capsules, orally, once daily for up to 24 weeks.
Also known as: AG-1749
TAK-438 placebo-matching tablets, orally, once daily for up to 24 weeks.
Recurrence rate of gastric or duodenal ulcer within 24 weeks
Mucosal defects with a white coating of 3 mm or larger will be determined as ulcers. Recurrence rate of gastric or duodenal ulcer within 24 weeks will be calculated for each treatment group.
Time frame: 24 weeks
Recurrence rate of gastric or duodenal ulcer within 12 weeks
Time frame: 12 weeks
Gastric mucosal injury
Time frame: 24 Weeks
Duodenal mucosal injury
Time frame: 24 weeks
Occurrence rate of hemorrhagic lesion in stomach or duodenum
Time frame: 24 weeks
Time to recurrence of gastric or duodenal ulcer
Time frame: 24 weeks
Showing the first 100 of 102 sites.
This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
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