Effect Of Treatment With Oral Zolpidem On Polysomnography And Actigraphy Measures In Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00716521
First received: June 23, 2008
Last updated: April 22, 2009
Last verified: April 2009

June 23, 2008
April 22, 2009
July 2008
October 2008   (final data collection date for primary outcome measure)
onset to persistent sleep [ Time Frame: minutes ] [ Designated as safety issue: No ]
onset to persistant sleep [ Time Frame: minutes ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00716521 on ClinicalTrials.gov Archive Site
awakenings after sleep onset [ Time Frame: minutes ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effect Of Treatment With Oral Zolpidem On Polysomnography And Actigraphy Measures In Healthy Volunteers
Subject- And Investigator-Blinded, Sponsor-Open, Randomized, Single-Dose, Placebo-Controlled, 3-Way Crossover Study To Study Effect Of Treatment With Oral Zolpidem On Polysomnography And Actigraphy Measures In Healthy Volunteers

This study will assess the feasibility of conducting sleep studies in a clinical research unit environment. In addition, the sensitivity of polysomnography and mobile actigraphy technologies will be compared for evaluating sleep stages and sleep architecture.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Methodology Study
  • Drug: placebo
    single oral dose placebo
  • Drug: zolpidem
    single oral dose, 5 mg zolpidem
  • Drug: zolpidem
    single oral dose, 10 mg zolpidem
  • Placebo Comparator: Placebo
    groups of 3-4 subjects for overnight polysomnography assessments
    Intervention: Drug: placebo
  • Experimental: Low dose Zolpidem
    Intervention: Drug: zolpidem
  • Experimental: High dose zolpidem
    Intervention: Drug: zolpidem
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
11
October 2008
October 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 18-55
  • BMI 18-30 kg/m2
  • body weight > 50 kg

Exclusion Criteria:

  • no history of sleep disorder
  • no concurrent medications
  • no alcohol use
  • no medical issues
  • no smoking
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00716521
A9001390
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP