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A Six Week, Double-Blind Randomized, Efficacy and Safety, Sleep Lab Trial With Esmirtazapine (Org 50081) (P05707)

Primary Purpose

Insomnia

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Esmirtazapine
Placebo
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia focused on measuring Sleep Initiation and Maintenance Disorders, Sleep Disorders, Intrinsic Dyssomnias, Sleep Disorders, Nervous System Diseases, Mental Disorders

Eligibility Criteria

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

Inclusion Criteria:

  • Documented diagnosis of chronic primary insomnia

Exclusion Criteria:

  • Other sleep disorder such as sleep apnea, restless leg syndrome, narcolepsy, sleep/wake rhythm disorders
  • Has significant medical or psychiatric illness as causing the sleep disorder
  • Diagnosed with major depressive disorder
  • Substance abuse within the past year
  • Night worker or work on rotating shifts
  • Has had serious head injury, stroke, epilepsy
  • Has a history of bipolar disorder or family (immediate family) history of suicide
  • Smokes more than 15 cigarettes per day and cannot abstain from smoking during the night or in the sleep laboratory
  • Drinks beverages containing more than 500 mg caffeine per day

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    Esmirtazapine 3.0 mg

    Esmirtazapine 4.5 mg

    Placebo

    Arm Description

    Participants took placebo tablets on Days -7 and -6, esmirtazapine 3.0 mg tablets on Days 1-42, and placebo tablets on Days 43-50. Tablets were taken by mouth once daily in the evening.

    Participants took placebo tablets on Days -7 and -6, esmirtazapine 4.5 mg tablets on Days 1-42, and placebo tablets on Days 43-50. Tablets were taken by mouth once daily in the evening.

    Participants took placebo tablets on Days -7 and -6, placebo tablets on Days 1-42, and placebo tablets on Days 43-50. Tablets were taken by mouth once daily in the evening.

    Outcomes

    Primary Outcome Measures

    Average Wake Time After Sleep Onset (WASO) During the In-Treatment Period
    WASO was defined as the total objective time awake after the onset of persistent sleep until the end of the 8-hour sleep cycle period as measured by polysomnography (PSG). WASO was calculated as the mean of Nights 1, 15, and 36.

    Secondary Outcome Measures

    Average Latency to Persistent Sleep (LPS) During the In-Treatment Period
    LPS was defined as the time in minutes from lights out to the first 20 consecutive epochs scored as sleep as measured by PSG. LPS was calculated as the mean of Nights 1, 15, and 36.
    Average Subjective Total Sleep Time (TST) During the In-Treatment Period
    TST was defined as the total amount of time in minutes that was actually spent sleeping the previous night as recorded daily in the participant's sleep diary. TST values over the 6 week In-Treatment Period were averaged for each participant, and average TST was then reported by treatment arm. For participants with missing data, the average of the nights for which TST data were available was used in the analysis.

    Full Information

    First Posted
    July 23, 2007
    Last Updated
    September 4, 2018
    Sponsor
    Merck Sharp & Dohme LLC
    Collaborators
    Parexel
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00506389
    Brief Title
    A Six Week, Double-Blind Randomized, Efficacy and Safety, Sleep Lab Trial With Esmirtazapine (Org 50081) (P05707)
    Official Title
    A Six-Week Double-Blind Randomized, Placebo-Controlled, Parallel Group, Efficacy and Safety, Sleep Lab Trial With Org 50081 in Patients With Chronic Primary Insomnia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    June 6, 2007 (Actual)
    Primary Completion Date
    February 13, 2008 (Actual)
    Study Completion Date
    February 13, 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC
    Collaborators
    Parexel

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this trial is to investigate the efficacy, safety and tolerability of esmirtazapine (Org 50081) compared to placebo in patients with chronic primary insomnia.
    Detailed Description
    Insomnia is a common complaint or disorder throughout the world. About one third of the population in the industrial countries reports difficulty initiating or maintaining sleep, resulting in a non-refreshing or non-restorative sleep. The majority of the insomniacs suffer chronically from their complaints. It has been reported that in patients with chronic insomnia lasting longer than six months, 50% had a past or current mental disorder. This raises the possibility that treatment of insomnia may reduce the risk for psychological conditions. This double-blind, placebo-controlled, parallel, randomized clinical trial is designed to assess the efficacy and safety of esmirtazapine in patients suffering from chronic primary insomnia.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Insomnia
    Keywords
    Sleep Initiation and Maintenance Disorders, Sleep Disorders, Intrinsic Dyssomnias, Sleep Disorders, Nervous System Diseases, Mental Disorders

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Esmirtazapine 3.0 mg
    Arm Type
    Experimental
    Arm Description
    Participants took placebo tablets on Days -7 and -6, esmirtazapine 3.0 mg tablets on Days 1-42, and placebo tablets on Days 43-50. Tablets were taken by mouth once daily in the evening.
    Arm Title
    Esmirtazapine 4.5 mg
    Arm Type
    Experimental
    Arm Description
    Participants took placebo tablets on Days -7 and -6, esmirtazapine 4.5 mg tablets on Days 1-42, and placebo tablets on Days 43-50. Tablets were taken by mouth once daily in the evening.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Participants took placebo tablets on Days -7 and -6, placebo tablets on Days 1-42, and placebo tablets on Days 43-50. Tablets were taken by mouth once daily in the evening.
    Intervention Type
    Drug
    Intervention Name(s)
    Esmirtazapine
    Other Intervention Name(s)
    ORG 50081
    Intervention Description
    Esmirtazapine maleate was provided as tablets for oral use containing 3.0 mg, or 4.5 mg of active compound. In addition, tablets contain the following excipients: hydroxypropyl cellulose, maize starch (United States Pharmacopeia [USP] name corn starch), magnesium stearate, and lactose monohydrate.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    The placebo tablets contained the following excipients: hydroxypropyl cellulose, maize starch (USP name corn starch), magnesium stearate, and lactose monohydrate.
    Primary Outcome Measure Information:
    Title
    Average Wake Time After Sleep Onset (WASO) During the In-Treatment Period
    Description
    WASO was defined as the total objective time awake after the onset of persistent sleep until the end of the 8-hour sleep cycle period as measured by polysomnography (PSG). WASO was calculated as the mean of Nights 1, 15, and 36.
    Time Frame
    From Day 1 to Day 36
    Secondary Outcome Measure Information:
    Title
    Average Latency to Persistent Sleep (LPS) During the In-Treatment Period
    Description
    LPS was defined as the time in minutes from lights out to the first 20 consecutive epochs scored as sleep as measured by PSG. LPS was calculated as the mean of Nights 1, 15, and 36.
    Time Frame
    From Day 1 to Day 36
    Title
    Average Subjective Total Sleep Time (TST) During the In-Treatment Period
    Description
    TST was defined as the total amount of time in minutes that was actually spent sleeping the previous night as recorded daily in the participant's sleep diary. TST values over the 6 week In-Treatment Period were averaged for each participant, and average TST was then reported by treatment arm. For participants with missing data, the average of the nights for which TST data were available was used in the analysis.
    Time Frame
    From Day 1 to Day 36

    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: Documented diagnosis of chronic primary insomnia Exclusion Criteria: Other sleep disorder such as sleep apnea, restless leg syndrome, narcolepsy, sleep/wake rhythm disorders Has significant medical or psychiatric illness as causing the sleep disorder Diagnosed with major depressive disorder Substance abuse within the past year Night worker or work on rotating shifts Has had serious head injury, stroke, epilepsy Has a history of bipolar disorder or family (immediate family) history of suicide Smokes more than 15 cigarettes per day and cannot abstain from smoking during the night or in the sleep laboratory Drinks beverages containing more than 500 mg caffeine per day

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
    IPD Sharing URL
    http://engagezone.msd.com/ds_documentation.php
    Citations:
    PubMed Identifier
    26047892
    Citation
    Ivgy-May N, Ruwe F, Krystal A, Roth T. Esmirtazapine in non-elderly adult patients with primary insomnia: efficacy and safety from a randomized, 6-week sleep laboratory trial. Sleep Med. 2015 Jul;16(7):838-44. doi: 10.1016/j.sleep.2015.04.001. Epub 2015 Apr 16.
    Results Reference
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    A Six Week, Double-Blind Randomized, Efficacy and Safety, Sleep Lab Trial With Esmirtazapine (Org 50081) (P05707)

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