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

Primary Purpose

Insomnia

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK0928, gaboxadol / Duration of Treatment - 1 year
Comparator: placebo / Duration of Treatment -1 year
Sponsored by
H. Lundbeck A/S
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of insomnia

Sites / Locations

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Patient-reported awakenings at night
    Sleep quality
    Functioning after 3 months

    Full Information

    First Posted
    October 29, 2004
    Last Updated
    January 13, 2015
    Sponsor
    H. Lundbeck A/S
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00095069
    Brief Title
    Efficacy and Safety of MK0928 for Insomnia in Adults (0928-003)(COMPLETED)
    Official 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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2004 (undefined)
    Primary Completion Date
    February 2007 (Actual)
    Study Completion Date
    February 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    H. Lundbeck A/S

    4. Oversight

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Insomnia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    600 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    MK0928, gaboxadol / Duration of Treatment - 1 year
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: placebo / Duration of Treatment -1 year
    Primary Outcome Measure Information:
    Title
    Patient-reported amount of sleep and time to fall sleep at night after three months
    Secondary Outcome Measure Information:
    Title
    Patient-reported awakenings at night
    Title
    Sleep quality
    Title
    Functioning after 3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    64 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of insomnia
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    20191935
    Citation
    Roth T, Lines C, Vandormael K, Ceesay P, Anderson D, Snavely D. Effect of gaboxadol on patient-reported measures of sleep and waking function in patients with Primary Insomnia: results from two randomized, controlled, 3-month studies. J Clin Sleep Med. 2010 Feb 15;6(1):30-9.
    Results Reference
    derived

    Learn more about this trial

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

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