Residual Effects of Zolpidem Tartrate Extended Release and Eszopiclone Vs Placebo

• ClinicalTrials.gov Identifier: NCT00283790
• Recruitment Status: Completed
• First Posted: January 30, 2006
• Last Update Posted: April 3, 2008
• Sponsor: Sanofi
• Information provided by: Sanofi

Study Description

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

Condition or disease	Intervention/treatment	Phase
Insomnia	Drug: zolpidem tartrate	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double
• Primary Purpose: Treatment
• 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 Start Date: January 2006
• Study Completion Date: April 2006

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

1. Psychometric testing:
2. Critical Flicker Fusion (CFF)
3. Choice Reaction Time (CRT)
4. Immediate and Delayed Recall of Supraspan Word Lists (WRI and WRD)
5. Compensatory Tracking Task (CTT)
6. Digit Symbol Substitution Test (DSST)

Secondary Outcome Measures :

1. Efficacy Measures:
2. Sleep measures from Morning Sleep Questionnaire
3. Residual Effects of Zolpidem Tartrate Extended Release and Eszopiclone Vs Placebo
4. Leeds Sleep Evaluation Questionnaire (LSEQ)
5. Bond & Lader (B&L) Visual Analog Scale
6. Health Outcome Measures
7. Sleep Treatment Questionnaire

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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).

Contacts and Locations

Locations

United States, New Jersey

Sanofi-Aventis

Bridgewater, New Jersey, United States, 08807

Sponsors and Collaborators

Sanofi

Investigators

• Study Director: Phyllis Diener; Sanofi

More Information

• ClinicalTrials.gov Identifier: NCT00283790
• Other Study ID Numbers: PM_L_0289
• First Posted: January 30, 2006
• Last Update Posted: April 3, 2008
• Last Verified: April 2008

Additional relevant MeSH terms:

Sleep Initiation and Maintenance Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Zolpidem; Sleep Aids, Pharmaceutical; Hypnotics and Sedatives; Central Nervous System Depressants; Physiological Effects of Drugs; GABA-A Receptor Agonists; GABA Agonists; GABA Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action