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

Tracking Information

First Received Date ^ICMJE

June 23, 2008

Last Updated Date

April 22, 2009

Start Date ^ICMJE

July 2008

Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

onset to persistent sleep [ Time Frame: minutes ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

onset to persistant sleep [ Time Frame: minutes ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00716521 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

awakenings after sleep onset [ Time Frame: minutes ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

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

Condition ^ICMJE

Methodology Study

Intervention ^ICMJE

Drug: placebo
single oral dose placebo
Drug: zolpidem
single oral dose, 5 mg zolpidem
Drug: zolpidem
single oral dose, 10 mg zolpidem

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2008

Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00716521

Other Study ID Numbers ^ICMJE

A9001390

Has Data Monitoring Committee

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer, Inc.

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

April 2009

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

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