MK0928 Study in Adult Patients With Primary Insomnia (0928-040)(COMPLETED)

A study to evaluate the efficacy, safety and tolerability of MK-0928 in Primary Insomnia.

Completed

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Key information

Conditions

Primary Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

20 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with a diagnosis of primary insomnia

Exclusion criteria

Patients with an active psychiatric disorder other than primary insomnia

Treatment and study plan

MK0928, gaboxadol / Duration of Treatment 3 Weeks

Drug

Placebo / Duration of Treatment 3 Weeks

Drug

Primary outcomes

Patient-reported total sleep time.

Secondary outcomes

Patient-reported time to sleep onset, number of awakenings, wake time after sleep onset and premature awakening.

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study title

MK0928 Phase IIb Dose-range Finding Study -Primary Insomnia

Important dates

Study start: 2005
Study completion: 2006
First posted: Dec 16, 2005
Registry last updated: Jan 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed