Safety and Efficacy of Dexlansoprazole Modified Release Formulation to Treat Gastroesophageal Reflux Disease
A Phase 3 Study to Evaluate the Efficacy and Safety of Dexlansoprazole MR (30 mg QD and 60 mg QD) Compared to Placebo on Symptom Relief in Subjects With Symptomatic Nonerosive Gastroesophageal Reflux Disease (GERD)
Sponsor: Takeda
This PHASE3 trial investigates Gastroesophageal Reflux Disease and is currently completed. Takeda leads this study, which shows 8 recorded versions since 2006 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.
Study Description(click to expand)This is a Phase 3, randomized, double-blind, multicenter, placebo-controlled, 3-arm study with a 4 week treatment period. This study will compare the efficacy of Dexlansoprazole MR (30 mg QD and 60 mg QD) with that of placebo when administered orally as a single daily dose in the morning, before breakfast. The study is designed to evaluate symptom relief in subjects with symptomatic nonerosive GERD. Approximately 900 subjects will be enrolled at approximately 200 United States (US) and potentially ex-US sites. The study consists of two periods: a screening period, which will last a minimum of 7 days and a maximum of 21 days, and a treatment period, which will last 4 weeks.
This is a Phase 3, randomized, double-blind, multicenter, placebo-controlled, 3-arm study with a 4 week treatment period. This study will compare the efficacy of Dexlansoprazole MR (30 mg QD and 60 mg QD) with that of placebo when administered orally as a single daily dose in the morning, before breakfast. The study is designed to evaluate symptom relief in subjects with symptomatic nonerosive GERD. Approximately 900 subjects will be enrolled at approximately 200 United States (US) and potentially ex-US sites. The study consists of two periods: a screening period, which will last a minimum of 7 days and a maximum of 21 days, and a treatment period, which will last 4 weeks.
Status Flow
Change History
8 versions recorded-
Jan 2026 — Present [monthly]
Completed PHASE3
-
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
▶ Show 3 earlier versions
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Jun 2018 — Jan 2021 [monthly]
Completed PHASE3
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Feb 2017 — Jun 2018 [monthly]
Completed PHASE3
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Jan 2017 — Feb 2017 [monthly]
Completed PHASE3
First recorded
Jun 2006
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 .