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Stilnox Treatment in Elderly Patients With Insomnia (STEP)

Primary Purpose

Insomnia

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Zolpidem
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia

Eligibility Criteria

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

Inclusion Criteria: Primary out-patient insomniac patient defined by DSM-IV criteria Insomnia history lasted at least 3 months , this history must include a self-reported usual sleep latency of 30 minutes or more and either 3 or more awakenings per night on average or a usual total sleep time of ≤6.5 hours Exclusion Criteria: Usage of hypnotics within the previous 1-3 weeks before inclusion depending on the half-life of the hypnotics that would affect the study effect Concomitant usage of other hypnotics (benzodiazepines and Non-benzodiazepines) during the course if the study. Concomitant usage of the following Central Nervous System active medicine : antipsychotics , antidepressants ,anxiolytics, lithium and other psychotropic drugs. The score of Hamilton Depression Rating Scale (HAMD-24 ) more than 17. The score of Hamilton Anxiety Rating Scale (HAMA-14 ) more than 14. Patients having known hypersensitivity to Stilnox or any of the ingredients in the products Patient with severe respiratory insufficiency Patients suffering from sleep apnoea syndrome Patients with known severe hepatic (risk of encephalopathy) and /or renal insufficiency, or other severe organ diseases Patients suffering from severe myasthenia gravis Patients with the previous history of drug abuse, drug dependence and drug addiction Any other disease state or major psychiatric condition that might affect study result The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    1

    Arm Description

    For 3 weeks

    Outcomes

    Primary Outcome Measures

    Pittsburgh Sleep Quality Index (PSQI) score

    Secondary Outcome Measures

    Pittsburgh Sleep Quality Index score
    Subject sleeping efficacy variable
    Hamilton Depression Rating Scale (HAMD) and Hamilton Anxiety Rating Scale (HAMA) score
    Adverse events (AE) and Serious adverse events (SAE) reports
    General Lab tests including hepatic and renal function
    Vital signs

    Full Information

    First Posted
    July 31, 2006
    Last Updated
    September 14, 2009
    Sponsor
    Sanofi
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00359229
    Brief Title
    Stilnox Treatment in Elderly Patients With Insomnia
    Acronym
    STEP
    Official Title
    A Multicentre Prospective, Open Label ,3 Weeks Phase IV Study to Evaluate the Efficacy and Safety in Elder Patients With Insomnia in China
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2006 (undefined)
    Primary Completion Date
    September 2007 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Sanofi

    4. Oversight

    5. Study Description

    Brief Summary
    Primary objective: 1. To evaluate the efficacy of Zolpidem 5mg for 1 week in elderly patients with insomnia in China Secondary objectives: To evaluate the safety of Zolpidem 5mg for 3 weeks in elderly patients with insomnia in China. To evaluate the efficacy of Zolpidem 5mg for 3 weeks in elderly patients with insomnia in China

    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 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    115 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    For 3 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Zolpidem
    Intervention Description
    Administration of Zolpidem 5mg
    Primary Outcome Measure Information:
    Title
    Pittsburgh Sleep Quality Index (PSQI) score
    Time Frame
    At 1 week versus baseline
    Secondary Outcome Measure Information:
    Title
    Pittsburgh Sleep Quality Index score
    Time Frame
    At 3 weeks versus baseline
    Title
    Subject sleeping efficacy variable
    Time Frame
    At 1 week and 3 weeks versus baseline
    Title
    Hamilton Depression Rating Scale (HAMD) and Hamilton Anxiety Rating Scale (HAMA) score
    Time Frame
    At 3 weeks versus baseline
    Title
    Adverse events (AE) and Serious adverse events (SAE) reports
    Time Frame
    Throughout the study period
    Title
    General Lab tests including hepatic and renal function
    Time Frame
    At 3 weeks versus baseline
    Title
    Vital signs
    Time Frame
    At 1 week and 3 weeks versus baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Primary out-patient insomniac patient defined by DSM-IV criteria Insomnia history lasted at least 3 months , this history must include a self-reported usual sleep latency of 30 minutes or more and either 3 or more awakenings per night on average or a usual total sleep time of ≤6.5 hours Exclusion Criteria: Usage of hypnotics within the previous 1-3 weeks before inclusion depending on the half-life of the hypnotics that would affect the study effect Concomitant usage of other hypnotics (benzodiazepines and Non-benzodiazepines) during the course if the study. Concomitant usage of the following Central Nervous System active medicine : antipsychotics , antidepressants ,anxiolytics, lithium and other psychotropic drugs. The score of Hamilton Depression Rating Scale (HAMD-24 ) more than 17. The score of Hamilton Anxiety Rating Scale (HAMA-14 ) more than 14. Patients having known hypersensitivity to Stilnox or any of the ingredients in the products Patient with severe respiratory insufficiency Patients suffering from sleep apnoea syndrome Patients with known severe hepatic (risk of encephalopathy) and /or renal insufficiency, or other severe organ diseases Patients suffering from severe myasthenia gravis Patients with the previous history of drug abuse, drug dependence and drug addiction Any other disease state or major psychiatric condition that might affect study result The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bruno Jolain
    Organizational Affiliation
    Sanofi
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Stilnox Treatment in Elderly Patients With Insomnia

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