Elderly Primary Insomnia Polysomnographic Study

This study has been terminated.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00094666

First received: October 21, 2004

Last updated: January 21, 2010

Last verified: January 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

October 21, 2004

Last Updated Date

January 21, 2010

Start Date ^ICMJE

November 2004

Primary Completion Date

March 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Amount of time spent awake and time to fall asleep at night after two days

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00094666 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Amount of time spent awake and time to fall asleep at night after 30 days
Amount of deep sleep after two days

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Elderly Primary Insomnia Polysomnographic Study

Official Title ^ICMJE

A Double-Blind, Randomized, Placebo-Controlled, Multicenter, 30-Night Polysomnographic Study of MK0928 in Elderly Patients With Primary Insomnia

Brief Summary

The purpose of the study is to test the safety and effectiveness of an Investigational Drug on insomnia in the elderly.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Primary Insomnia

Intervention ^ICMJE

Drug: MK0928, gaboxadol / Duration of Treatment - 6 weeks
Drug: Comparator: placebo / Duration of Treatment - 6 weeks

Study Arm (s)

Not Provided

Publications *

Lankford DA, Corser BC, Zheng YP, Li Z, Snavely DB, Lines CR, Deacon S. Effect of gaboxadol on sleep in adult and elderly patients with primary insomnia: results from two randomized, placebo-controlled, 30-night polysomnography studies. Sleep. 2008 Oct 1;31(10):1359-70.

* 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

Terminated

Enrollment ^ICMJE

465

Completion Date

March 2007

Primary Completion Date

March 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Elderly patients with a diagnosis of primary insomnia and in good physical and mental health

Gender

Both

Ages

65 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00094666

Other Study ID Numbers ^ICMJE

2004_085, MK0928-002

Has Data Monitoring Committee

Not Provided

Responsible Party

Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

January 2010

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

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