Residual Effects of Zolpidem Tartrate Extended Release and Eszopiclone Vs Placebo

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00283790
First received: January 27, 2006
Last updated: April 1, 2008
Last verified: April 2008
  Purpose

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 Intervention Phase
Insomnia
Drug: zolpidem tartrate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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:
  • 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

Estimated Enrollment: 36
Study Start Date: January 2006
Estimated Study Completion Date: April 2006
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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00283790

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

No publications provided

ClinicalTrials.gov Identifier: NCT00283790     History of Changes
Other Study ID Numbers: PM_L_0289
Study First Received: January 27, 2006
Last Updated: April 1, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Zolpidem
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014