Efficacy and Safety of TAK-438 for the Prevention of Recurrent Gastric or Duodenal Ulcers During Therapy of Non-steroidal Anti-inflammatory Drug (NSAID)
A Phase 3, Multicenter, Randomized, Double-blind, AG-1749-controlled, Parallel-group, Comparison Study to Evaluate the Efficacy and Safety of TAK-438 (10 mg or 20 mg, Orally, Once Daily) for the Prevention of Recurrent Gastric or Duodenal Ulcers During Long-term Therapy of Non-steroidal Anti-inflammatory Drug (NSAID).
Sponsor: Takeda
This PHASE3 trial investigates Duodenal Ulcers and Gastric Ulcers and is currently completed. Takeda leads this study, which shows 6 recorded versions since 2011 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.
Status Flow
Change History
6 versions recorded-
Sep 2025 — Present [monthly]
Completed PHASE3
-
Sep 2024 — Sep 2025 [monthly]
Completed PHASE3
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE3
-
Jan 2021 — Jul 2024 [monthly]
Completed PHASE3
-
Jun 2018 — Jan 2021 [monthly]
Completed PHASE3
▶ Show 1 earlier version
-
Jan 2017 — Jun 2018 [monthly]
Completed PHASE3
First recorded
Oct 2011
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Takeda
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
Adachi-ku, Japan , Ageo-shi, Japan , Akashi-shi, Japan , Akita, Japan , Asahikawa-shi, Japan , Beppu-shi, Japan , Bunkyo-ku, Japan , Fukui-shi, Japan , Fukuoka, Japan , Fukushima, Japan and 92 more locations