- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00283790
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
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
-
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New Jersey
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Bridgewater, New Jersey, United States, 08807
- Sanofi-Aventis
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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:
- 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
EXCLUSION CRITERIA:
- 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).
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 |
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Psychometric testing:
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Critical Flicker Fusion (CFF)
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Choice Reaction Time (CRT)
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Immediate and Delayed Recall of Supraspan Word Lists (WRI and WRD)
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Compensatory Tracking Task (CTT)
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Digit Symbol Substitution Test (DSST)
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Secondary Outcome Measures
Outcome Measure |
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Efficacy Measures:
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Sleep measures from Morning Sleep Questionnaire
|
Residual Effects of Zolpidem Tartrate Extended Release and Eszopiclone Vs Placebo
|
Leeds Sleep Evaluation Questionnaire (LSEQ)
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Bond & Lader (B&L) Visual Analog Scale
|
Health Outcome Measures
|
Sleep Treatment Questionnaire
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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
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PM_L_0289
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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