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A Prospective Active-Reference Study of Gaboxadol in Primary Insomnia

Primary Purpose

Primary Insomnia

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Gaboxadol
Sponsored by
H. Lundbeck A/S
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Insomnia focused on measuring Primary insomnia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: diagnosis of Primary insomnia

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Efficacy
    Safety
    Tolerability

    Secondary Outcome Measures

    Full Information

    First Posted
    September 13, 2005
    Last Updated
    March 29, 2007
    Sponsor
    H. Lundbeck A/S
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00209937
    Brief Title
    A Prospective Active-Reference Study of Gaboxadol in Primary Insomnia
    Official Title
    A Prospective Randomised Double-Blind Parallel-Group Placebo-Controlled Active-Reference Study of Gaboxadol in Primary Insomnia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2007
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2003 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    June 2004 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    H. Lundbeck A/S

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To evaluate the efficacy safety and tolerability of gaboxadol in primary insomnia
    Detailed Description
    To compare the hypnotic efficacy and safety of different dose levels of gaboxadol with placebo in non-elderly patients with primary insomnia over two weeks of treatment

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Gaboxadol
    Primary Outcome Measure Information:
    Title
    Efficacy
    Title
    Safety
    Title
    Tolerability

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: diagnosis of Primary insomnia
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Please contact: Annelies van der Hammen Legters
    Organizational Affiliation
    H. Lundbeck A/S
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    A Prospective Active-Reference Study of Gaboxadol in Primary Insomnia

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