Trials / Completed
CompletedNCT00660660
Local Phase IV, Gastroesophageal Reflux Disease (GERD) Sleep Study US
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Efficacy Study Comparing 4 Weeks of Treatment With Esomeprazole 20 mg qd to Placebo qd in Patients With Heartburn and Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD)
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 276 (actual)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this research study is to compare the safety and effectiveness (how well the medicine works) of esomeprazole (study drug) to placebo (a capsule that does not contain any medication) taken daily in relieving nighttime heartburn and problems sleeping in patients with gastroesophageal reflux disease (GERD).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Esomeprazole | Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate |
| DRUG | Placebo | once daily |
Timeline
- Start date
- 2008-04-01
- Primary completion
- 2008-07-01
- Completion
- 2008-07-01
- First posted
- 2008-04-17
- Last updated
- 2015-03-02
- Results posted
- 2015-03-02
Locations
45 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00660660. Inclusion in this directory is not an endorsement.