NCT01468038

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 111 (actual)
• Sponsor: Targeted Medical Pharma · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Sleep Disorder

Interventions

Type	Name	Description
DRUG	Trazodone	active trazodone and sentra pm-like placebo
OTHER	Sentra PM	Active Sentra PM and trazodone-like placebo
DRUG	Sentra PM and Trazodone (CoPack Kit Trazamine)	A CoPack Kit - Trazamine, consisting of the co-administration of Sentra PM and trazodone.
DRUG	Placebo trazodone and placebo Sentra PM	Trazodone-like placebo and Sentra PM-like placebo co-administered as placebo of Trazamine CoPack Kit.

Timeline

• Start date: 2008-04-01
• Primary completion: 2008-10-01
• Completion: 2008-12-01
• First posted: 2011-11-09
• Last updated: 2011-11-09

Locations

1 site across 1 country: United States