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

NCT01468038 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 111

Last updated 2011-11-09

No results posted yet for this study

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.

Conditions

  • Sleep Disorder

Interventions

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.

Sponsors & Collaborators

  • Targeted Medical Pharma

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2008-10-31
Completion
2008-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01468038 on ClinicalTrials.gov