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Study of the Safety and Effectiveness of Esmirtazapine in Participants With Chronic Primary Insomnia (P05706) (RUBY)

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

Eligibility Criteria

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

Inclusion Criteria:

  • Has signed written informed consent after the scope and nature of the investigation was explained to them
  • Has difficulty falling asleep, maintaining sleep or has early morning awakenings

Exclusion Criteria:

  • Significant medical or psychiatric illness causing sleep disturbances
  • Has a history of bipolar disorder or family (immediate family) of suicide
  • Has sleep disorder such as sleep related breathing disorder, restless leg syndrome, narcolepsy
  • Has significant other medical illness such as acute or chronic pain, heart, kidney or liver disease within the last year
  • Currently diagnosed or meets the criteria for Major Depressive Disorder (MDD) or has been treated for MDD with the last 2 years
  • Substance abuse, excessive use of alcohol (as determined by the physician) or drug addiction within the last year.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    Esmirtazapine 1.5 mg

    Esmirtazapine 3.0 mg

    Esmirtazapine 4.5 mg

    Placebo

    Arm Description

    Esmirtazapine 1.5 mg tablet, oral administration in the evening, once daily, for 2 weeks

    Esmirtazapine 3.0 mg tablet, oral administration in the evening, once daily, for 2 weeks

    Esmirtazapine 4.5 mg tablet, oral administration in the evening, once daily, for 2 weeks

    Placebo to esmirtazapine

    Outcomes

    Primary Outcome Measures

    Average Total Sleep Time (TST) as Recorded Daily in the Sleep Diary During the 14-day In-treatment Period
    TST was defined as the total amount of time (measured in minutes) that was actually spent sleeping the previous night as recorded daily in the participant's sleep diary. TST values over the 14-day active 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 present was used in the analysis.

    Secondary Outcome Measures

    Average Sleep Latency (SL) as Recorded Daily in the Sleep Diary During the 14-day In-treatment Period
    SL was defined as the duration of time measured in minutes that it took a participant to fall asleep as recorded daily in the participant's sleep diary. SL values over the 14-day active treatment period were averaged for each participant, and average SL was then reported by treatment arm. For participants with missing data, the average of the nights for which TST data were present were used in the analysis.
    Number of Participants Experiencing an Adverse Event (AE) During the 14-day In-treatment Period
    The total number of participants with an AE during the 14-day In-treatment Period was tallied for each treatment arm. An AE was defined as any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
    Number of Participants Who Discontinued From Study Treatment Due to an AE During the 14-day In-Treatment Period
    The total number of participants discontinuing from study treatment due to experiencing an AE was tallied for each treatment arm. An AE was defined as any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

    Full Information

    First Posted
    June 1, 2007
    Last Updated
    September 4, 2018
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00482612
    Brief Title
    Study of the Safety and Effectiveness of Esmirtazapine in Participants With Chronic Primary Insomnia (P05706)
    Acronym
    RUBY
    Official Title
    A Two-Week, Double Blind, Placebo-Controlled, Randomized, Parallel Group, Efficacy and Safety Out-Patient 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
    December 7, 2006 (Actual)
    Primary Completion Date
    August 11, 2008 (Actual)
    Study Completion Date
    August 11, 2008 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to determine if esmirtazapine (Org 50081) is a safe and effective treatment for insomnia. It was anticipated that esmirtazapine would increase mean Total Sleep Time (TST) as recorded in sleep diaries relative to placebo.

    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
    526 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Esmirtazapine 1.5 mg
    Arm Type
    Experimental
    Arm Description
    Esmirtazapine 1.5 mg tablet, oral administration in the evening, once daily, for 2 weeks
    Arm Title
    Esmirtazapine 3.0 mg
    Arm Type
    Experimental
    Arm Description
    Esmirtazapine 3.0 mg tablet, oral administration in the evening, once daily, for 2 weeks
    Arm Title
    Esmirtazapine 4.5 mg
    Arm Type
    Experimental
    Arm Description
    Esmirtazapine 4.5 mg tablet, oral administration in the evening, once daily, for 2 weeks
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo to esmirtazapine
    Intervention Type
    Drug
    Intervention Name(s)
    Esmirtazapine
    Other Intervention Name(s)
    Org 50081, MK-8265
    Intervention Description
    Esmirtazapine maleate was provided as tablets for oral use containing either 1.5, 3.0, 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. Tablets were administered orally once daily about 30 minutes prior to bedtime.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo tablets containing the following excipients: hydroxypropyl cellulose, maize starch (USP name: corn starch), magnesium stearate, and lactose monohydrate. Tablets were administered orally once daily about 30 minutes prior to bedtime.
    Primary Outcome Measure Information:
    Title
    Average Total Sleep Time (TST) as Recorded Daily in the Sleep Diary During the 14-day In-treatment Period
    Description
    TST was defined as the total amount of time (measured in minutes) that was actually spent sleeping the previous night as recorded daily in the participant's sleep diary. TST values over the 14-day active 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 present was used in the analysis.
    Time Frame
    Day 1 to Day 15
    Secondary Outcome Measure Information:
    Title
    Average Sleep Latency (SL) as Recorded Daily in the Sleep Diary During the 14-day In-treatment Period
    Description
    SL was defined as the duration of time measured in minutes that it took a participant to fall asleep as recorded daily in the participant's sleep diary. SL values over the 14-day active treatment period were averaged for each participant, and average SL was then reported by treatment arm. For participants with missing data, the average of the nights for which TST data were present were used in the analysis.
    Time Frame
    Day 1 to Day 15
    Title
    Number of Participants Experiencing an Adverse Event (AE) During the 14-day In-treatment Period
    Description
    The total number of participants with an AE during the 14-day In-treatment Period was tallied for each treatment arm. An AE was defined as any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
    Time Frame
    Day 1 to Day 15
    Title
    Number of Participants Who Discontinued From Study Treatment Due to an AE During the 14-day In-Treatment Period
    Description
    The total number of participants discontinuing from study treatment due to experiencing an AE was tallied for each treatment arm. An AE was defined as any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
    Time Frame
    Day 1 to Day 15

    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: Has signed written informed consent after the scope and nature of the investigation was explained to them Has difficulty falling asleep, maintaining sleep or has early morning awakenings Exclusion Criteria: Significant medical or psychiatric illness causing sleep disturbances Has a history of bipolar disorder or family (immediate family) of suicide Has sleep disorder such as sleep related breathing disorder, restless leg syndrome, narcolepsy Has significant other medical illness such as acute or chronic pain, heart, kidney or liver disease within the last year Currently diagnosed or meets the criteria for Major Depressive Disorder (MDD) or has been treated for MDD with the last 2 years Substance abuse, excessive use of alcohol (as determined by the physician) or drug addiction within the last year.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Director
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    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
    26047890
    Citation
    Ivgy-May N, Roth T, Ruwe F, Walsh J. Esmirtazapine in non-elderly adult patients with primary insomnia: efficacy and safety from a 2-week randomized outpatient trial. Sleep Med. 2015 Jul;16(7):831-7. doi: 10.1016/j.sleep.2015.03.005. Epub 2015 Mar 30.
    Results Reference
    result

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