A Double-blind Placebo Controlled Trial of Sentra PM, a Medical Food
Completed · Phase 3 · Has a placebo group
Conditions studied: Sleep Disorder
In brief
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.
Key facts
- Study ID
- NCT01468038
- Run by
- Targeted Medical Pharma
- People needed
- 111
- Starts
- 2008-04-01
- Expected to finish
- 2008-12-01
- Last updated by the study team
- 2011-11-09
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Males and females over the age of 18 and below age 65.
- Patients with a history of a sleep disturbance with non-restorative sleep defined by perceived increase in sleep latency or morning/daytime grogginess.
You may not qualify if…
- Subjects who have previously taken GABAdone, SentraPM or trazadone.
- Subjects who are currently taking tricyclic anti-depressants.
- Any blood chemistry anomalies the investigator finds that may put the patient at risk or invalidate study results.
- Pregnant or lactating females.
- Subjects with implanted pacemakers or other implanted electrical devices
Where it is running
- Targeted Medical Pharma — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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