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

Information source: Targeted Medical Pharma
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Sleep Disorder

Intervention: Trazodone (Drug); Sentra PM (Other); Sentra PM and Trazodone (CoPack Kit Trazamine) (Drug); Placebo trazodone and placebo Sentra PM (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Targeted Medical Pharma

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.

Clinical Details

Official title: Sentra PM (a Medical Food) and Trazadone in the Management of Sleep Disorders

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Time to fall asleep

Secondary outcome:

Quality of Sleep

Morning grogginess

Feelings of depression

Feelings of anxiety

Improvement in parasympathetic activity

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 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.

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Targeted Medical Pharma, Los Angeles, California 90077, United States
Additional Information

Physician Therapeutics

Starting date: April 2008
Last updated: November 8, 2011

Page last updated: August 23, 2015

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