Status:
COMPLETED
A Double-blind Placebo Controlled Trial of Sentra PM, a Medical Food
Lead Sponsor:
Targeted Medical Pharma
Conditions:
Sleep Disorder
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
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 alon...
Detailed Description
Sentra PM can induce restorative sleep compared to placebo, and as good as a sleep drug (trazadone) in subjects experiencing non-restorative sleep. Sentra PM taken with trazadone works better than eit...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
111 Patients enrolled
Trial Details
Trial ID
NCT01468038
Start Date
April 1 2008
End Date
December 1 2008
Last Update
November 9 2011
Active Locations (1)
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1
Targeted Medical Pharma
Los Angeles, California, United States, 90077