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Investigation of Melatonin and Zolpidem Effect on Postural Instability in Healthy Adult Subjects

NCT01280734 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2011-12-13

No results posted yet for this study

Summary

This is a randomised, double-blind, 3-way crossover, single dose, placebo-controlled study investigating the effect on night time awakening body sway of melatonin and zolpidem in healthy adult subjects aged of 55 to 64 years.

Conditions

  • Postural Instability

Interventions

DRUG

Circadin (R) 2 mg

One 2 mg tablet at 23:00

DRUG

Stilnox (R) 10 mg

One 10 mg encapsulated tablet at 23:00

DRUG

Placebo

One tablet or encapsulated tablet at 23:00

Sponsors & Collaborators

  • Neurim Pharmaceuticals Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
55 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2011-04-30
Completion
2011-05-31

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

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 NCT01280734 on ClinicalTrials.gov