Trials / Unknown
UnknownNCT01128582
Effect of Rozerem on the Perception of GERD Symptoms in Patients With Chronic Insomnia.
Effect of Rozerem on the Perception of Gastroesophageal Reflux Disease (GERD) Symptoms in Patients With Chronic Insomnia.
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- Sponsor
- Southern Arizona VA Health Care System · Federal
- Sex
- All
- Age
- 82 Years
- Healthy volunteers
- Not accepted
Summary
To determine if administration of Rozerem in comparison to a placebo reduces or eliminates gastroesophageal reflux disease(GERD) symptoms in individuals with both GERD and chronic insomnia.
Detailed description
This is a prospective, randomized, double-blind parallel group study comparing the effect of Rozerem vs. placebo on gastroesophageal reflux disease(GERD) symptomatology as the primary outcome, and sleep quality and quality of life as secondary outcomes.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Rozerem (ramelteon) | dosage= take 1 tablet(8 MG) 20 min. before bedtime |
| DRUG | placebo | Comparing the effect of Rozerem vs. placebo on GERD symptomatology. |
Timeline
- Start date
- 2009-03-01
- Primary completion
- 2011-12-01
- Completion
- 2011-12-01
- First posted
- 2010-05-24
- Last updated
- 2011-05-12
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01128582. Inclusion in this directory is not an endorsement.