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

Sleep Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01468038
• Other study ID #: SentraPM102
• Status: Completed
• Phase: Phase 3
• First received: November 5, 2011
• Last updated: November 8, 2011
• Start date: April 2008
• Est. completion date: December 2008

Study information

• Verified date: November 2011
• Source: Targeted Medical Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: December 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Parasomnias
• Sleep Disorder
• Sleep Disorders

Intervention

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

Locations

Country	Name	City	State
United States	Targeted Medical Pharma	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Targeted Medical Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Quality of Sleep		14 days	No
Secondary	Morning grogginess		14 days	No
Secondary	Feelings of depression		14 days	No
Secondary	Feelings of anxiety		14 days	No
Secondary	Improvement in parasympathetic activity	Improved parasympathetic activity measured by 24 hour ECG holter moniter.	14 days	No

External Links

•   Physician Therapeutics