Study of MK0928 in Healthy Adult Volunteers in a Model of Insomnia

This study has been completed.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00102167

First received: January 21, 2005

Last updated: January 21, 2010

Last verified: January 2010

History of Changes

Purpose

A study to evaluate the safety and effectiveness of Study of MK0928 in Healthy Adult Volunteers in a Model of Insomnia for insomnia (a sleep disorder).

Condition	Intervention	Phase
Insomnia	Drug: gaboxadol	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Study of MK0928 in Healthy Adult Volunteers Participating in a 4-Hour Phase Advance Model of Transient Insomnia

Further study details as provided by Merck:

Primary Outcome Measures:

Amount of time spent awake and time to fall asleep during one night [ Time Frame: one night ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Amount of deep sleep during one night. [ Time Frame: one night ] [ Designated as safety issue: No ]
Patient-reported sleep quality and awakenings during 1 night. [ Time Frame: one night ] [ Designated as safety issue: No ]

Enrollment:	663
Study Start Date:	February 2005
Study Completion Date:	December 2005

Intervention Details:

Duration of Treatment -1 day

Other Name: MK0928

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy adults who are between the ages of 18 and 64

Exclusion Criteria:

Adults who are diagnosed with insomnia

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00102167

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Publications:

Walsh JK, Mayleben D, Guico-Pabia C, Vandormael K, Martinez R, Deacon S. Efficacy of the selective extrasynaptic GABA A agonist, gaboxadol, in a model of transient insomnia: a randomized, controlled clinical trial. Sleep Med. 2008 May;9(4):393-402. Epub 2007 Aug 30.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ma J, Dijk DJ, Svetnik V, Tymofyeyev Y, Ray S, Walsh JK, Deacon S. EEG power spectra response to a 4-h phase advance and gaboxadol treatment in 822 men and women. J Clin Sleep Med. 2011 Oct 15;7(5):493-501A.

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00102167 History of Changes
Other Study ID Numbers:	2004_092, MK0928-006
Study First Received:	January 21, 2005
Last Updated:	January 21, 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
4,5,6,7-tetrahydroisoxazolo(5,4-c)pyridin-3-ol
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses

Pharmacologic Actions
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 19, 2013

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