Last reviewed · How we verify
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
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.
Details
| Lead sponsor | Takeda |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 178 |
| Start date | 2009-02 |
| Completion | 2010-04 |
Conditions
- Gastroesophageal Reflux
Interventions
- Dexlansoprazole MR QD
Primary outcomes
- Proportion of Participants Who Remain Well Controlled After Switching From Their Current Twice-daily Proton Pump Inhibitor Therapy to Dexlansoprazole MR. — Week 3 through Week 6
Well-controlled participants were defined to be participants who completed the study having at least 23 days of evaluable diary entries between Days 15 and 42, inclusive, and had ≤4 occurrences of heartburn during this period.
Countries
United States