Phase IIB 2-Period Crossover PSG Study in Patients With Primary Insomnia

This study has been completed.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00792298

First received: November 10, 2008

Last updated: May 25, 2010

Last verified: May 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

November 10, 2008

Last Updated Date

May 25, 2010

Start Date ^ICMJE

November 2008

Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Improvement in sleep efficiency as measured by polysomnography [ Time Frame: polysomnography over 4 weeks of treatment ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Improvement in sleep efficiency (100 x time asleep divided by time in bed) as measured by polysomnography. [ Time Frame: Polysomnography on Night 1 and after 4 weeks of treatment ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00792298 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Improvement in wake after sleep onset and latency to persistent sleep. [ Time Frame: polysomnography over 4 weeks of treatment ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Evaluate the efficacy of MK4305 compared with placebo in improving wake after sleep onset and latency to persistent sleep. [ Time Frame: Polysomnography on Night 1 and after 4 weeks of treatment ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Phase IIB 2-Period Crossover PSG Study in Patients With Primary Insomnia

Official Title ^ICMJE

A Phase IIb, Multicenter, Randomized, Double-Blind Placebo-Controlled, 2-period Crossover Polysomnography Study to Evaluate Safety and Efficacy of MK4305 in Patients With Primary Insomnia

Brief Summary

A cross-over, polysomnography study to test the safety, tolerability and effectiveness of different doses of MK4305 in the treatment of patients with primary insomnia.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Primary Insomnia

Intervention ^ICMJE

Drug: MK4305
MK4305 10 mg or placebo taken before bedtime
Drug: Comparator: MK4305.
MK4305 20 mg or placebo taken before bedtime
Drug: Comparator: MK4305,
MK4305 40 mg or placebo taken before bedtime
Drug: Comparator: MK4305..
MK4305 80 mg or placebo taken before bedtime

Study Arm (s)

Experimental: 1
MK4305 10 mg and matching placebo

Intervention: Drug: MK4305
Experimental: 2
MK4305 20 mg and matching placebo

Intervention: Drug: Comparator: MK4305.
Experimental: 3
MK4305 40 mg and matching placebo

Intervention: Drug: Comparator: MK4305,
Experimental: 4
MK4305 80 mg and matching placebo

Intervention: Drug: Comparator: MK4305..

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

254

Completion Date

December 2009

Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Between the ages of 18 and 64 years
Must be willing to stay overnight at a sleep laboratory
Must be willing to stay in bed for at least 8 hours each night while at the sleep laboratory
Regular bedtime is between 9 PM and 12 AM (midnight)

Exclusion Criteria:

Breast feeding, pregnant or planning to become pregnant during the study
Within the past 6 months before starting the study you have a history of significant cardiovascular disorder such as unstable angina, congestive heart - failure or acute coronary syndrome
Currently participating or have participated in a study with an investigational compound or device within the last 30 days.
Have traveled across 3 or more time zones in the last 2 weeks or plan on traveling across 3 or more time zones during the next 2 months.
Have done shift work within the past 2 weeks
Have donated blood products within the last 8 weeks
Have difficulty sleeping due to a medical condition

Gender

Both

Ages

18 Years to 64 Years

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

NCT00792298

Other Study ID Numbers ^ICMJE

2008_583, MK4305-006

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

May 2010

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

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