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Completed

NCT Number: NCT00103818

An Investigational Study of MK0928 in Adult Outpatients With Insomnia (0928-014)(COMPLETED)

The purpose of this study is to evaluate the safety and effectiveness of MK0928 for insomnia (a sleep disorder).

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Key information

Conditions

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

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult outpatients who are between the ages of 18 and 64

Exclusion criteria

  • Adults who do not have a diagnosis of insomnia (a sleep disorder)

Treatment and study plan

Gaboxadol

Drug

Duration of Treatment: 3 months

Other names: MK0928

Comparator: Placebo (Unspecified)

Drug

Duration of Treatment: 3 months

Primary outcomes

  1. Patient-reported amount of sleep and time to fall asleep at night after 3 months

    Time frame: After 3 months

Secondary outcomes

  1. Patient-reported awakenings at night

    Time frame: After 3 months

  2. Sleep quality

    Time frame: After 3 months

  3. Functioning after 3 months

    Time frame: After 3 months

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study title

A Double-Blind, Randomized, Multicenter, Placebo-Controlled, Parallel-Group Efficacy Study of MK0928 15 mg and 10 mg in the Treatment of Adult Outpatients With Primary Insomnia

Important dates

Study start
2005
Study completion
2006
First posted
Feb 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.

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