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OpenTrials
Completed

NCT Number: NCT00095069

Efficacy and Safety of MK0928 for Insomnia in Adults (0928-003)(COMPLETED)

The purpose of this trial is to study the safety and effectiveness of MK0928 for adults with insomnia.

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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

  • Diagnosis of insomnia

Treatment and study plan

MK0928, gaboxadol / Duration of Treatment - 1 year

Drug

Comparator: placebo / Duration of Treatment -1 year

Drug

Primary outcomes

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

Secondary outcomes

  1. Patient-reported awakenings at night

  2. Sleep quality

  3. Functioning 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-Groups Efficacy and Safety Extension Study of MK0928 in the Treatment of Adult Outpatients With Primary Insomnia

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Nov 1, 2004
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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