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A Double-blind Placebo Controlled Trial of Sentra PM, a Medical Food

NCT ID: NCT01468038

Last Updated: 2011-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2008-12-31

Brief Summary

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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.

Detailed Description

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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 either product alone. Twenty-six subjects will be randomized to a two week ingestion of Sentra PM at bedtime, twenty-six subjects will be randomized to a two week ingestion of trazadone at bedtime, twenty-six subjects will be randomized to a two week ingestion of Sentra PM with trazadone at bedtime and twenty -six subjects will be randomized to a two week ingestion of placebo at bedtime. Each morning after ingestion of either active product or placebo, the subject will fill out sleep questionnaires. On the fourteenth day of ingestion, a repeat 24-Hour ECG examination will be performed on all one hundred and four subjects and each subject will give a second blood sample for analysis. On the morning of the 14th day of ingestion the final sleep questionnaires will be completed.

Conditions

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Sleep Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Active trazodone and placebo

trazodone 50mg with Sentra PM-like placebo

Group Type ACTIVE_COMPARATOR

Trazodone

Intervention Type DRUG

active trazodone and sentra pm-like placebo

placebo and active Sentra PM

Trazodone-like placebo and Sentra PM

Group Type ACTIVE_COMPARATOR

Sentra PM

Intervention Type OTHER

Active Sentra PM and trazodone-like placebo

Sentra PM and trazodone

Active Sentra PM and active trazodone

Group Type ACTIVE_COMPARATOR

Sentra PM and Trazodone (CoPack Kit Trazamine)

Intervention Type DRUG

A CoPack Kit - Trazamine, consisting of the co-administration of Sentra PM and trazodone.

placebo trazodone and placebo Sentra PM

trazadone-like placebo and Sentra PM-like placebo

Group Type PLACEBO_COMPARATOR

Placebo trazodone and placebo Sentra PM

Intervention Type DRUG

Trazodone-like placebo and Sentra PM-like placebo co-administered as placebo of Trazamine CoPack Kit.

Interventions

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Trazodone

active trazodone and sentra pm-like placebo

Intervention Type DRUG

Sentra PM

Active Sentra PM and trazodone-like placebo

Intervention Type OTHER

Sentra PM and Trazodone (CoPack Kit Trazamine)

A CoPack Kit - Trazamine, consisting of the co-administration of Sentra PM and trazodone.

Intervention Type DRUG

Placebo trazodone and placebo Sentra PM

Trazodone-like placebo and Sentra PM-like placebo co-administered as placebo of Trazamine CoPack Kit.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Targeted Medical Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Targeted Medical Pharma

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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SentraPM102

Identifier Type: -

Identifier Source: org_study_id