A Double-blind Placebo Controlled Trial of Sentra PM, a Medical Food
Sentra PM (a Medical Food) and Trazadone in the Management of Sleep Disorders
1 other identifier
interventional
111
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2008
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 5, 2011
CompletedFirst Posted
Study publicly available on registry
November 9, 2011
CompletedNovember 9, 2011
November 1, 2011
6 months
November 5, 2011
November 8, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Time to fall asleep
Subjects time to fall asleep will be measure by patient response to questionnaires to determine if time improved, stayed the same or worsen.
14 days
Secondary Outcomes (5)
Quality of Sleep
14 days
Morning grogginess
14 days
Feelings of depression
14 days
Feelings of anxiety
14 days
Improvement in parasympathetic activity
14 days
Study Arms (4)
Active trazodone and placebo
ACTIVE COMPARATORtrazodone 50mg with Sentra PM-like placebo
placebo and active Sentra PM
ACTIVE COMPARATORTrazodone-like placebo and Sentra PM
Sentra PM and trazodone
ACTIVE COMPARATORActive Sentra PM and active trazodone
placebo trazodone and placebo Sentra PM
PLACEBO COMPARATORtrazadone-like placebo and Sentra PM-like placebo
Interventions
A CoPack Kit - Trazamine, consisting of the co-administration of Sentra PM and trazodone.
Trazodone-like placebo and Sentra PM-like placebo co-administered as placebo of Trazamine CoPack Kit.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Targeted Medical Pharma
Los Angeles, California, 90077, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 5, 2011
First Posted
November 9, 2011
Study Start
April 1, 2008
Primary Completion
October 1, 2008
Study Completion
December 1, 2008
Last Updated
November 9, 2011
Record last verified: 2011-11