Trials / Completed
CompletedNCT00627016
A Study of Dexlansoprazole Modified Release Formulation to Treat Night Heartburn
A Phase 3 Multicenter, Randomized, Double-Blind, Parallel Group, Placebo Controlled Trial to Evaluate the Efficacy of TAK-390MR (30 mg QD) Compared to Placebo on Relief of Nocturnal Heartburn in Subjects With Symptomatic Gastroesophageal Reflux Disease (GERD)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 305 (actual)
- Sponsor
- Takeda · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine whether Dexlansoprazole once daily (QD) is effective in treating patients with night heartburn.
Detailed description
This 4 week study of Dexlansoprazole (TAK-390MR) will be conducted by approximately 50 investigators in the United States in patients suffering from night heartburn.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dexlansoprazole | 30 mg capsule, orally, once daily for 4 weeks |
| DRUG | Placebo | 1 capsule, orally, once daily for 4 weeks |
Timeline
- Start date
- 2008-03-01
- Primary completion
- 2009-03-01
- Completion
- 2009-03-01
- First posted
- 2008-02-29
- Last updated
- 2011-04-28
- Results posted
- 2010-05-06
Locations
43 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00627016. Inclusion in this directory is not an endorsement.