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

Purpose

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.

Condition	Intervention	Phase
Primary Insomnia	Drug: MK4305 Drug: Comparator: MK4305. Drug: Comparator: MK4305, Drug: Comparator: MK4305..	Phase 2

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

Further study details as provided by Merck:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Enrollment:	254
Study Start Date:	November 2008
Study Completion Date:	December 2009
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 MK4305 10 mg and matching placebo	Drug: MK4305 MK4305 10 mg or placebo taken before bedtime
Experimental: 2 MK4305 20 mg and matching placebo	Drug: Comparator: MK4305. MK4305 20 mg or placebo taken before bedtime
Experimental: 3 MK4305 40 mg and matching placebo	Drug: Comparator: MK4305, MK4305 40 mg or placebo taken before bedtime
Experimental: 4 MK4305 80 mg and matching placebo	Drug: Comparator: MK4305.. MK4305 80 mg or placebo taken before bedtime

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00792298

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00792298 History of Changes
Other Study ID Numbers:	2008_583, MK4305-006
Study First Received:	November 10, 2008
Last Updated:	May 25, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias

Sleep Disorders
Nervous System Diseases
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013

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