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Efficacy and Safety of Ramelteon on Chronic Insomnia

Primary Purpose

Chronic Insomnia

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Ramelteon and Placebo (25 possible combinations total)
Sponsored by
Takeda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Insomnia focused on measuring Insomnia, Sleep Initiation and Maintenance Disorders, Drug Therapy

Eligibility Criteria

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

Inclusion Criteria:

  • Has primary chronic insomnia for at least 3 months.
  • Has a mean latency of greater than or equal to 20 minutes on 2 consecutive polysomnography screening nights with no night less than 15 minutes, and has a mean of at least 60 minutes of wake time across 2 nights with no night less than 45 minutes.
  • Has a habitual bedtime between 8:30 PM and 12:00 AM.
  • Has a body mass index that is not less than 17, but less than 34.
  • Females of childbearing potential who are sexually active must agree to use a medically accepted means of contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.

Exclusion Criteria:

  • Has a history of psychiatric disorder (including depression and anxiety), seizures, drug addiction, sleep apnea, nocturnal myoclonus and/or mental retardation as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition.
  • Has a history of alcohol abuse within the previous 2 years.
  • Has a hepatic disease, and a significant neurological, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematological or metabolic disease.
  • Has a known hypersensitivity to ramelteon or related compounds, including melatonin.
  • Has a positive hepatitis panel including hepatitis A, hepatitis B or hepatitis C.
  • Has any clinically abnormal findings as determined by a medical history, physical examination, electrocardiogram or clinical laboratory tests by the investigator or sub investigator.
  • Has experienced 3 hours or more of jet lag within 7 days preceding the polysomnography screening.
  • Has an apnea-hypopnea index (per hour of sleep) greater than or equal to 10 as seen on the first night of polysomnography screening.
  • Has periodic limb movement with arousal index (per hour o sleep) greater than or equal to 10 as seen on the first night of polysomnography screening.
  • Has participated in an excessive weight loss program that may have given influence on the evaluation of this study, or altered the participant's exercise routine within 30 days prior to double-blind study medication administration.
  • Has had a clinically significant illness within 30 days prior to double-blind study medication administration.
  • Has had sleep schedule changes required by employment (e.g., shift worker) within 3 months prior to double-blind study medication administration.
  • The investigator or sub investigator judges the study subject inappropriate for participation because it is considered difficult to complete the study, or participating in the study will not be in the best interest of the subject.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Ramelteon QD and Placebo QD (25 possible combinations total)

    Arm Description

    Outcomes

    Primary Outcome Measures

    Mean Latency to Persistent Sleep

    Secondary Outcome Measures

    Mean Total Sleep Time
    Sleep Efficiency
    Awake Time after Persistent Sleep
    Percent of Total Sleep Time in NREM sleep Stage 1
    Percent of Total Sleep Time in NREM sleep Stage 2
    Percent of Total Sleep Time in NREM sleep Stage 3/4
    Percent of Total Sleep Time in REM sleep Stage
    Latency to REM sleep stage
    Subjective Sleep Latency
    Subjective Total Sleep Time
    Subjective Sleep Quality

    Full Information

    First Posted
    June 3, 2009
    Last Updated
    May 31, 2010
    Sponsor
    Takeda
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00915135
    Brief Title
    Efficacy and Safety of Ramelteon on Chronic Insomnia
    Official Title
    A Double-Blind, Dose-Response, Cross-Over Study of TAK-375 With Chronic Insomnia (Phase II Study) -- Polysomnographic Evaluation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2002 (undefined)
    Primary Completion Date
    December 2003 (Actual)
    Study Completion Date
    December 2003 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Takeda

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to determine the dose response of Ramelteon, once daily (QD), in Japanese subjects with Chronic Insomnia
    Detailed Description
    Complaints of sleep disorder are increasing with today's aging society and changing lifestyle. Sleep disorders not only impact one's activities of daily living, but also impede one's social life, leading to reduced productivity and sometimes accidents through carelessness. Ramelteon is a melatonin-1 receptor agonist under global development by Takeda Chemical Industries, Ltd., Osaka, Japan, for the treatment of transient and chronic insomnia and for the treatment of Circadian Rhythm Sleep Disorders.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Insomnia
    Keywords
    Insomnia, Sleep Initiation and Maintenance Disorders, Drug Therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    66 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Ramelteon QD and Placebo QD (25 possible combinations total)
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Ramelteon and Placebo (25 possible combinations total)
    Other Intervention Name(s)
    Ramelteon, Rozerem, TAK-375
    Intervention Description
    Randomized sequence over two consecutive nights for a total of five treatment periods to include the following: Ramelteon 4 mg, tablets, orally over two nights Ramelteon 8 mg, tablets, orally over two nights Ramelteon 16 mg, tablets, orally over two nights Ramelteon 32 mg, tablets, orally over two nights Ramelteon placebo-matching tablets, orally over two nights
    Primary Outcome Measure Information:
    Title
    Mean Latency to Persistent Sleep
    Time Frame
    Mean of Nights 1 and 2.
    Secondary Outcome Measure Information:
    Title
    Mean Total Sleep Time
    Time Frame
    Mean of Nights 1 and 2.
    Title
    Sleep Efficiency
    Time Frame
    Mean of Nights 1 and 2
    Title
    Awake Time after Persistent Sleep
    Time Frame
    Mean of Nights 1 and 2.
    Title
    Percent of Total Sleep Time in NREM sleep Stage 1
    Time Frame
    Mean of Nights 1 and 2.
    Title
    Percent of Total Sleep Time in NREM sleep Stage 2
    Time Frame
    Mean of Nights 1 and 2.
    Title
    Percent of Total Sleep Time in NREM sleep Stage 3/4
    Time Frame
    Mean of Nights 1 and 2.
    Title
    Percent of Total Sleep Time in REM sleep Stage
    Time Frame
    Mean of Nights 1 and 2.
    Title
    Latency to REM sleep stage
    Time Frame
    Mean of Nights 1 and 2.
    Title
    Subjective Sleep Latency
    Time Frame
    Mean of Nights 1 and 2.
    Title
    Subjective Total Sleep Time
    Time Frame
    Mean of Nights 1 and 2.
    Title
    Subjective Sleep Quality
    Time Frame
    Mean of Nights 1 and 2.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Has primary chronic insomnia for at least 3 months. Has a mean latency of greater than or equal to 20 minutes on 2 consecutive polysomnography screening nights with no night less than 15 minutes, and has a mean of at least 60 minutes of wake time across 2 nights with no night less than 45 minutes. Has a habitual bedtime between 8:30 PM and 12:00 AM. Has a body mass index that is not less than 17, but less than 34. Females of childbearing potential who are sexually active must agree to use a medically accepted means of contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study. Exclusion Criteria: Has a history of psychiatric disorder (including depression and anxiety), seizures, drug addiction, sleep apnea, nocturnal myoclonus and/or mental retardation as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition. Has a history of alcohol abuse within the previous 2 years. Has a hepatic disease, and a significant neurological, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematological or metabolic disease. Has a known hypersensitivity to ramelteon or related compounds, including melatonin. Has a positive hepatitis panel including hepatitis A, hepatitis B or hepatitis C. Has any clinically abnormal findings as determined by a medical history, physical examination, electrocardiogram or clinical laboratory tests by the investigator or sub investigator. Has experienced 3 hours or more of jet lag within 7 days preceding the polysomnography screening. Has an apnea-hypopnea index (per hour of sleep) greater than or equal to 10 as seen on the first night of polysomnography screening. Has periodic limb movement with arousal index (per hour o sleep) greater than or equal to 10 as seen on the first night of polysomnography screening. Has participated in an excessive weight loss program that may have given influence on the evaluation of this study, or altered the participant's exercise routine within 30 days prior to double-blind study medication administration. Has had a clinically significant illness within 30 days prior to double-blind study medication administration. Has had sleep schedule changes required by employment (e.g., shift worker) within 3 months prior to double-blind study medication administration. The investigator or sub investigator judges the study subject inappropriate for participation because it is considered difficult to complete the study, or participating in the study will not be in the best interest of the subject.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Director
    Organizational Affiliation
    Takeda
    Official's Role
    Study Director

    12. IPD Sharing Statement

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    Efficacy and Safety of Ramelteon on Chronic Insomnia

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