Residual Effects of Zolpidem Tartrate Extended Release and Eszopiclone Vs Placebo

NCT00283790 | Completed Phase 4

• 1 other identifier: PM_L_0289
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Insomnia

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (7)

• 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

Interventions

zolpidem tartrate DRUG

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male and female subjects aged between 18 and 45 years.
• Usual bedtime between 21:00 and 01:00
• Body mass index (BMI) between 18 and 32 kg/m2.
• Certified as healthy by a comprehensive clinical assessment (detailed medical history and a complete physical examination).
• Laboratory tests within the normal range of the laboratory (hematology, biochemistry, urinalysis) or within the acceptable range per agreement between investigator and sponsor.
• Negative urine pregnancy test for females (to be confirmed at screening and prior to every dose of study medication)
• 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.
• Written informed consent signed

You may not qualify if:

• 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
• Any disorder initiating or maintaining sleep such as Obstructive Sleep Apnea, Insomnia, Restless Leg Syndrome, Periodic Limb Movement Disorder, Circadian Rhythm Disorder and Parasomnia
• Frequent headaches and/or migraine, recurrent nausea and/or vomiting (more than twice a month).
• 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.
• History of hypersensitivity to zolpidem, eszopiclone, or flurazepam.
• Use of any medication within one month prior to study start, except occasional use of acetaminophen or ibuprofen.
• History of drug abuse during prior twelve months
• Excessive consumption of xanthine-based beverages (more than 6 cups or glasses per day) or unable to stop consumption during the overnight study periods.
• Inability to communicate or cooperate with the investigator because of a language problem, poor mental status, or impaired cerebral status.
• Positive results of urine drug screen testing (amphetamines, benzodiazepines, cannabis, barbiturates, cocaine, opiates, antidepressants).
• Any use of dietary, herbal, and/or fitness/body-building supplements (with the exception of vitamins)
• 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
• Subject is currently participating in another clinical trial with an investigation product/device (or within 30 days of screening).

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis

Bridgewater, New Jersey, 08807, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Zolpidem

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Phyllis Diener

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 27, 2006
• First Posted: January 30, 2006
• Study Start: January 1, 2006
• Study Completion: April 1, 2006
• Last Updated: April 3, 2008

Record last verified: 2008-04

Locations

US (1)