At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 178 enrolled
Drug / intervention
Dexlansoprazole MR QDdrug
Likely dose
Dexlansoprazole MR QD 30 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3b Multicenter, Single-Blind Trial to Evaluate the Efficacy of Dexlansoprazole MR 30 mg in Maintaining Control of Gastroesophageal Reflux Disease Symptoms in Subjects on Prior Twice Daily Proton Pump Inhibitor Therapy
In Brief
A Phase 3 clinical trial evaluating Dexlansoprazole MR QD for Gastroesophageal Reflux. Completed, enrolled 178 participants across 52 sites.
Detailed Summary
The purpose of this study is to determine if patients with well-controlled heartburn symptoms on twice-daily proton pump inhibitor therapy remain well-controlled after stepping down to once-daily (QD) dexlansoprazole modified release (MR) 30 mg.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastroesophageal Reflux
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2009
First PostedFeb 2009
Primary CompletionApr 2010
TodayJul 2026
First PostedFeb 19, 2009
Enrollment StartFeb 1, 2009
Primary CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 17.4 years ago
Interventions
Dexlansoprazole MR QDdrug
Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.