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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Methodology Study
 Drug: placebo
Drug: zolpidem
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • onset to persistent sleep [ Time Frame: minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • awakenings after sleep onset [ Time Frame: minutes ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: July 2008
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
groups of 3-4 subjects for overnight polysomnography assessments
 Drug: placebo
single oral dose placebo
Experimental: Low dose Zolpidem Drug: zolpidem
single oral dose, 5 mg zolpidem
Experimental: High dose zolpidem Drug: zolpidem
single oral dose, 10 mg zolpidem

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00716521

Locations
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00716521     History of Changes
Other Study ID Numbers: A9001390
Study First Received: June 23, 2008
Last Updated: April 22, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Pfizer:
mobile actigraphy inpatient polysomnography actigraphy ambien

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 May 21, 2013