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Sentra PM (a Medical Food) and Trazadone in the Management of Sleep Disorders
This is a double blind placebo controlled study of one hundred and four subjects which will be randomized for treatment with Sentra PM alone, Sentra PM with trazadone, trazadone alone and placebo alone. Twenty -six subjects will be randomly placed in one of the four groups. Each of the one hundred and four subjects will undergo baseline examination to include a sleep study questionnaires and 24- hour electrocardiographic recording. The one hundred and four subjects will then be randomly placed in one of the four groups.
Details
| Lead sponsor | Targeted Medical Pharma |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 111 |
| Start date | 2008-04 |
| Completion | 2008-12 |
Conditions
- Sleep Disorder
Interventions
- Trazodone
- Sentra PM
- Sentra PM and Trazodone (CoPack Kit Trazamine)
- Placebo trazodone and placebo Sentra PM
Primary outcomes
- Time to fall asleep — 14 days
Subjects time to fall asleep will be measure by patient response to questionnaires to determine if time improved, stayed the same or worsen.
Countries
United States