Residual Effects of Zolpidem Tartrate Extended Release and Eszopiclone Vs Placebo

April 1, 2008 updated by: Sanofi

Investigation of Psycliomotor and Cognitive Residual Effects After Single Oral Doses of Zolpidem Tartrate Extended Release 12.5 mg and Eszopielone 3 mg Compared to Placebo in Healthy Young Volunteers, Using Plurazepam 30 mg As An External Comparator

Investigation of Psychomotor and Cognitive Residual Effects of Single Oral Doses of Zolpidem Tartrate Extended Release 12.5 mg and Eszopiclone 3 mg Compared to Placebo in Healthy Young Volunteers, Using Flurazepam 30 mg as an External Comparator

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a crossover study, with 4 different treatments (Ambien, Lunesta, placebo, and flurazepam). The flurazepam arm always comes last due to the long washout period associated with it. The other 3 arms are randomized.

Study Type

Interventional

Enrollment

36

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New Jersey
      • Bridgewater, New Jersey, United States, 08807
        • Sanofi-Aventis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

INCLUSION CRITERIA:

  1. Healthy male and female subjects aged between 18 and 45 years.
  2. Usual bedtime between 21:00 and 01:00
  3. Body mass index (BMI) between 18 and 32 kg/m2.
  4. Certified as healthy by a comprehensive clinical assessment (detailed medical history and a complete physical examination).
  5. Laboratory tests within the normal range of the laboratory (hematology, biochemistry, urinalysis) or within the acceptable range per agreement between investigator and sponsor.
  6. Negative urine pregnancy test for females (to be confirmed at screening and prior to every dose of study medication)
  7. Women must use a medically acceptable form of contraception (steroidal contraceptive, double-barrier, or intra-uterine device) during the entire study period, or they must be surgically sterilized or post-menopausal. If abstinent, women must agree to use double-barrier contraception throughout the study period should they become sexually active.
  8. Written informed consent signed

EXCLUSION CRITERIA:

  1. Presence or history of clinically relevant cardiovascular, hepatic, pulmonary, gastrointestinal, renal, metabolic, hematological, neurologic or psychiatric disease, any acute infectious disease or signs of acute illness, and myasthenia gravis
  2. Any disorder initiating or maintaining sleep such as Obstructive Sleep Apnea, Insomnia, Restless Leg Syndrome, Periodic Limb Movement Disorder, Circadian Rhythm Disorder and Parasomnia
  3. Frequent headaches and/or migraine, recurrent nausea and/or vomiting (more than twice a month).
  4. Symptomatic hypotension, whatever the decrease of blood pressure, or asymptomatic postural hypotension defined by a decrease in SBP equal to or greater than 20 mmHg within two minutes when changing from the supine to the standing position.
  5. History of hypersensitivity to zolpidem, eszopiclone, or flurazepam.
  6. Use of any medication within one month prior to study start, except occasional use of acetaminophen or ibuprofen.
  7. History of drug abuse during prior twelve months
  8. Excessive consumption of xanthine-based beverages (more than 6 cups or glasses per day) or unable to stop consumption during the overnight study periods.
  9. Inability to communicate or cooperate with the investigator because of a language problem, poor mental status, or impaired cerebral status.
  10. Positive results of urine drug screen testing (amphetamines, benzodiazepines, cannabis, barbiturates, cocaine, opiates, antidepressants).
  11. Any use of dietary, herbal, and/or fitness/body-building supplements (with the exception of vitamins)
  12. Current use of tobacco products including cigarettes, cigars, pipes, or chewing tobacco, current participation in a smoking cessation program, or discontinuation of smoking within 3 months prior to screening
  13. Subject is currently participating in another clinical trial with an investigation product/device (or within 30 days of screening).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Psychometric testing:
Critical Flicker Fusion (CFF)
Choice Reaction Time (CRT)
Immediate and Delayed Recall of Supraspan Word Lists (WRI and WRD)
Compensatory Tracking Task (CTT)
Digit Symbol Substitution Test (DSST)

Secondary Outcome Measures

Outcome Measure
Efficacy Measures:
Sleep measures from Morning Sleep Questionnaire
Residual Effects of Zolpidem Tartrate Extended Release and Eszopiclone Vs Placebo
Leeds Sleep Evaluation Questionnaire (LSEQ)
Bond & Lader (B&L) Visual Analog Scale
Health Outcome Measures
Sleep Treatment Questionnaire

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Study Completion

April 1, 2006

Study Registration Dates

First Submitted

January 27, 2006

First Submitted That Met QC Criteria

January 27, 2006

First Posted (Estimate)

January 30, 2006

Study Record Updates

Last Update Posted (Estimate)

April 3, 2008

Last Update Submitted That Met QC Criteria

April 1, 2008

Last Verified

April 1, 2008

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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