Residual Effects of Zolpidem Tartrate Extended Release and Eszopiclone Vs Placebo
Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Insomnia
Intervention: zolpidem tartrate (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Sanofi Official(s) and/or principal investigator(s): Phyllis Diener, Study Director, Affiliation: Sanofi
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
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: 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: 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
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
Criteria:
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).
Locations and Contacts
Sanofi-Aventis, Bridgewater, New Jersey 08807, United States
Additional Information
Starting date: January 2006
Last updated: April 1, 2008
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