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

Targeted Medical Pharma

Status and phase: Completed; Phase 3

Conditions: Sleep Disorder

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01468038

SentraPM102

Details and patient eligibility

About

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.

Full 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.

Enrollment: 111 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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111 participants in 4 patient groups, including a placebo group

Active trazodone and placebo

Active Comparator group

Description:

trazodone 50mg with Sentra PM-like placebo

Treatment:

Drug: Trazodone

placebo and active Sentra PM

Active Comparator group

Description:

Trazodone-like placebo and Sentra PM

Treatment:

Other: Sentra PM

Sentra PM and trazodone

Active Comparator group

Description:

Active Sentra PM and active trazodone

Treatment:

Drug: Sentra PM and Trazodone (CoPack Kit Trazamine)

placebo trazodone and placebo Sentra PM

Placebo Comparator group

Description:

trazadone-like placebo and Sentra PM-like placebo

Treatment:

Drug: Placebo trazodone and placebo Sentra PM