Trial record 6 of 387 for:    "Sleep Initiation and Maintenance Disorders"

Safety and Efficacy Study of Ramelteon in Subjects With Chronic Insomnia

This study has been completed.
Sponsor:
Information provided by:
Takeda
ClinicalTrials.gov Identifier:
NCT00756002
First received: September 17, 2008
Last updated: May 31, 2010
Last verified: May 2010
  Purpose

The purpose of this study is to determine the safety and efficacy of 4 mg of Ramelteon, once daily (QD), in subjects with chronic insomnia.


Condition Intervention Phase
Sleep Initiation and Maintenance Disorders
Drug: Ramelteon
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Polysomnography Plus Outpatient Study to Determine the Safety and Efficacy of 4 mg Ramelteon in Adults With Chronic Insomnia

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Mean Latency to Persistent Sleep Via Polysomnography (Nights 1-2). [ Time Frame: Nights 1-2 ] [ Designated as safety issue: No ]
    Elapsed time from the beginning of the Polysomnography recording to the onset of the first 10 minutes of continuous sleep was measured over 2 nights and the average time to sleep was calculated.


Secondary Outcome Measures:
  • Mean Latency to Persistent Sleep Via Polysomnography (Nights 15-16). [ Time Frame: Nights 15-16 ] [ Designated as safety issue: No ]
    Elapsed time from the beginning of the Polysomnography recording to the onset of the first 10 minutes of continuous sleep was measured.

  • Mean Latency to Persistent Sleep Via Polysomnography (Nights 29-30). [ Time Frame: Nights 29-30 ] [ Designated as safety issue: No ]
    Elapsed time from the beginning of the Polysomnography recording to the onset of the first 10 minutes of continuous sleep was measured.

  • Subjective Sleep Latency, Per Post-sleep Questionnaire (Nights 1-2). [ Time Frame: Nights 1-2 ] [ Designated as safety issue: No ]
    Subjective sleep latency was collected by subjects answering a post-sleep questionnaire via an interactive voice response system (IVRS) following an overnight Polysomnography in the sleep lab.

  • Subjective Sleep Latency, Per Post-sleep Questionnaire (Nights 15-16). [ Time Frame: Nights 15-16 ] [ Designated as safety issue: No ]
    Subjective sleep latency was collected by subjects answering a post-sleep questionnaire (via IVRS) following an overnight Polysomnography in the sleep lab.

  • Subjective Sleep Latency, Per Post-sleep Questionnaire (Nights 29-30). [ Time Frame: Nights 29-30 ] [ Designated as safety issue: No ]
    Subjective sleep latency was collected by subjects answering a post-sleep questionnaire (via IVRS) following an overnight Polysomnography in the sleep lab.

  • Subjective Sleep Latency, Per Post-sleep Questionnaire (Week 2). [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
    Subjects answered a post-sleep questionnaire via IVRS. The Subjective Sleep Latency weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting.

  • Subjective Sleep Latency, Per Post-sleep Questionnaire (Week 4). [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    Subjects answered a post-sleep questionnaire via IVRS. The Subjective Sleep Latency weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting.

  • Subjective Sleep Latency, Per Post-sleep Questionnaire (Week 5). [ Time Frame: Week 5 ] [ Designated as safety issue: No ]
    Subjects answered a post-sleep questionnaire via IVRS. The Subjective Sleep Latency weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting.

  • Total Sleep Time, Per Polysomnography (Nights 1-2). [ Time Frame: Nights 1-2 ] [ Designated as safety issue: No ]
    All of the minutes of Stages 1, 2, 3/4 Non Rapid Eye-Movement (NREM) and Rapid-Eye-Movement (REM) sleep, as measured by Polysomnography, are summed to determine the Total Sleep Time.

  • Total Sleep Time, Per Polysomnography (Nights 15-16). [ Time Frame: Nights 15-16 ] [ Designated as safety issue: No ]
    All of the minutes of Stages 1, 2, 3/4 NREM and REM sleep, as measured by Polysomnography, are summed to determine the Total Sleep Time.

  • Total Sleep Time, Per Polysomnography (Nights 29-30). [ Time Frame: Nights 29-30 ] [ Designated as safety issue: No ]
    All of the minutes of Stages 1, 2, 3/4 NREM and REM sleep, as measured by Polysomnography, are summed to determine the Total Sleep Time.

  • Subjective Total Sleep Time, Per Post-sleep Questionnaire (Nights 1-2). [ Time Frame: Nights 1-2 ] [ Designated as safety issue: No ]
    Subjects answered a Post-Sleep Questionnaire in the sleep lab the morning following overnight Polysomnography. Subjective Total Sleep Time measured the average of the 2 mornings after each overnight Polysomnography Visit.

  • Subjective Total Sleep Time, Per Post-sleep Questionnaire (Nights 15-16). [ Time Frame: Nights 15-16 ] [ Designated as safety issue: No ]
    Subjects answered a Post-Sleep Questionnaire in the sleep lab the morning following overnight Polysomnography. Subjective Total Sleep Time measured the average of the 2 mornings after each overnight Polysomnography Visit.

  • Subjective Total Sleep Time, Per Post-sleep Questionnaire (Nights 29-30). [ Time Frame: Nights 29 -30 ] [ Designated as safety issue: No ]
    Subjects answered a Post-Sleep Questionnaire in the sleep lab the morning following overnight Polysomnography. Subjective Total Sleep Time measured the average of the 2 mornings after each overnight Polysomnography Visit.

  • Subjective Total Sleep Time, Per Post-sleep Questionnaire (Week 2). [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
    Subjects answered a Post-Sleep Questionnaire via IVRS. The Subjective Total Sleep Time weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting.

  • Subjective Total Sleep Time, Per Post-sleep Questionnaire (Week 4). [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    Subjects answered a Post-Sleep Questionnaire via IVRS. The Subjective Total Sleep Time weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting.

  • Subjective Total Sleep Time, Per Post-sleep Questionnaire (Week 5). [ Time Frame: Week 5 ] [ Designated as safety issue: No ]
    Subjects answered a Post-Sleep Questionnaire via IVRS. The Subjective Total Sleep Time weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting.

  • Sleep Efficiency, Per Polysomnography (Nights 1-2). [ Time Frame: Nights 1-2 ] [ Designated as safety issue: No ]
    The total sleep time was divided by the total time in bed (ie, the number of minutes from the beginning of the Polysomnography recording to the end of the recording), multiplied by 100.

  • Sleep Efficiency, Per Polysomnography (Nights 15-16). [ Time Frame: Nights 15-16 ] [ Designated as safety issue: No ]
    The total sleep time was divided by the total time in bed (ie, the number of minutes from the beginning of the Polysomnography recording to the end of the recording), multiplied by 100.

  • Sleep Efficiency, Per Polysomnography (Nights 29-30). [ Time Frame: Nights 29-30 ] [ Designated as safety issue: No ]
    The Total Sleep Time was divided by the total time in bed (ie, the number of minutes from the beginning of the Polysomnography recording to the end of the recording), multiplied by 100.

  • Subjective Sleep Quality, Per Post-sleep Questionnaire (Nights 1-2). [ Time Frame: Nights 1-2 ] [ Designated as safety issue: No ]
    Sleep quality obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography. 7=Extremely Poor; 6=Very Poor; 5=Poor; 4=Fair; 3=Good; 2=Very Good; 1=Excellent.

  • Subjective Sleep Quality, Per Post-sleep Questionnaire (Nights 15-16). [ Time Frame: Nights 15-16 ] [ Designated as safety issue: No ]
    Sleep quality obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography. 7=Extremely Poor; 6=Very Poor; 5=Poor; 4=Fair; 3=Good; 2=Very Good; 1=Excellent.

  • Subjective Sleep Quality, Per Post-sleep Questionnaire (Nights 29-30). [ Time Frame: Nights 29-30 ] [ Designated as safety issue: No ]
    Sleep quality obtained from the Post-Sleep Questionnaireperformed in the sleep lab the morning following overnight Polysomnography. 7=Extremely Poor; 6=Very Poor; 5=Poor; 4=Fair; 3=Good; 2=Very Good; 1=Excellent.

  • Subjective Sleep Quality, Per Post-sleep Questionnaire (Week 2). [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
    The subjective sleep quality weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting. 7=Extremely Poor; 6=Very Poor; 5=Poor; 4=Fair; 3=Good; 2=Very Good; 1=Excellent.

  • Subjective Sleep Quality, Per Post-sleep Questionnaire (Week 4). [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    The subjective sleep quality weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting. 7=Extremely Poor; 6=Very Poor; 5=Poor; 4=Fair; 3=Good; 2=Very Good; 1=Excellent.

  • Subjective Sleep Quality, Per Post-sleep Questionnaire (Week 5). [ Time Frame: Week 5 ] [ Designated as safety issue: No ]
    The subjective sleep quality weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting. 7=Extremely Poor; 6=Very Poor; 5=Poor; 4=Fair; 3=Good; 2=Very Good; 1=Excellent.

  • Wake Time After Sleep Onset, Per Polysomnography (Nights 1-2). [ Time Frame: Nights 1-2 ] [ Designated as safety issue: No ]
    The number of minutes in the Awake stage after the onset of persistent sleep to the end of the recording.

  • Wake Time After Sleep Onset, Per Polysomnography (Nights 15-16). [ Time Frame: Nights 15-16 ] [ Designated as safety issue: No ]
    The number of minutes in the Awake stage after the onset of persistent sleep to the end of the recording.

  • Wake Time After Sleep Onset, Per Polysomnography (Nights 29-30). [ Time Frame: Nights 29-30 ] [ Designated as safety issue: No ]
    The number of minutes in the Awake stage after the onset of persistent sleep to the end of the recording.

  • Subjective Wake Time After Sleep Onset, Per Post-sleep Questionnaire (Nights 1-2). [ Time Frame: Nights 1-2 ] [ Designated as safety issue: No ]
    Subjective Wake Time After Sleep Onset obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography.

  • Subjective Wake Time After Sleep Onset, Per Post-sleep Questionnaire (Nights 15-16). [ Time Frame: Nights 15-16 ] [ Designated as safety issue: No ]
    Subjective Wake Time After Sleep Onset obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography.

  • Subjective Wake Time After Sleep Onset, Per Post-sleep Questionnaire (Nights 29-30). [ Time Frame: Nights 29-30 ] [ Designated as safety issue: No ]
    Subjective Wake Time After Sleep Onset obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography.

  • Subjective Wake Time After Sleep Onset, Per Post-sleep Questionnaire (Week 2). [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
    The Subjective Wake Time After Sleep Onset weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting.

  • Subjective Wake Time After Sleep Onset, Per Post-sleep Questionnaire (Week 4). [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    The Subjective Wake Time After Sleep Onset weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting.

  • Subjective Wake Time After Sleep Onset, Per Post-sleep Questionnaire (Week 5). [ Time Frame: Week 5 ] [ Designated as safety issue: No ]
    The Subjective Wake Time After Sleep Onset weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting.

  • Number of Awakenings After Persistent Sleep, Per Polysomnography (Nights 1-2). [ Time Frame: Nights 1-2 ] [ Designated as safety issue: No ]
    Number of Awakenings is defined as the number of times after the onset of persistent sleep that there is a wake entry of at least 2 epochs in duration. Each entry must be separated by Stage 2, 3/4 NREM sleep or REM sleep in order to be counted.

  • Number of Awakenings After Persistent Sleep, Per Polysomnography (Nights 15-16). [ Time Frame: Nights 15-16 ] [ Designated as safety issue: No ]
    Number of Awakenings is defined as the number of times after the onset of persistent sleep that there is a wake entry of at least 2 epochs in duration. Each entry must be separated by Stage 2, 3/4 NREM sleep or REM sleep in order to be counted.

  • Number of Awakenings After Persistent Sleep, Per Polysomnography (Nights 29-30). [ Time Frame: Nights 29-30 ] [ Designated as safety issue: No ]
    Number of Awakenings is defined as the number of times after the onset of persistent sleep that there is a wake entry of at least 2 epochs in duration. Each entry must be separated by Stage 2, 3/4 NREM sleep or REM sleep in order to be counted.

  • Subjective Number of Awakenings, Per Post-sleep Questionnaire (Nights 1-2). [ Time Frame: Nights 1-2 ] [ Designated as safety issue: No ]
    Subjective Number of Awakenings (the subjective measure of how many times the subject believes they awoke during the night) obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography. The average of two nights' data is used for each subject at a visit.

  • Subjective Number of Awakenings, Per Post-sleep Questionnaire (Nights 15-16). [ Time Frame: Nights 15-16 ] [ Designated as safety issue: No ]
    Subjective Number of Awakenings (the subjective measure of how many times the subject believes they awoke during the night) obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography. The average of two nights' data is used for each subject at a visit.

  • Subjective Number of Awakenings, Per Post-sleep Questionnaire (Nights 29-30). [ Time Frame: Nights 29-30 ] [ Designated as safety issue: No ]
    Subjective Number of Awakenings (the subjective measure of how many times the subject believes they awoke during the night) obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography. The average of two nights' data is used for each subject at a visit.

  • Subjective Number of Awakenings, Per Post-sleep Questionnaire (Week 2). [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
    The Subjective Number of Awakenings weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting.

  • Subjective Number of Awakenings, Per Post-sleep Questionnaire (Week 4). [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    The Subjective Number of Awakenings weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting.

  • Subjective Number of Awakenings, Per Post-sleep Questionnaire (Week 5). [ Time Frame: Week 5 ] [ Designated as safety issue: No ]
    The Subjective Number of Awakenings weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting.


Enrollment: 259
Study Start Date: August 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ramelteon 4 mg QD Drug: Ramelteon
Ramelteon 4 mg, tablets, orally, once daily for up to 5 weeks.
Other Names:
  • Rozerem™
  • Ramelteon
  • TAK-375
Placebo Comparator: Placebo QD Drug: Placebo
Ramelteon placebo-matching tablets, orally, once daily for up to 5 weeks.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A female subject of childbearing potential who is sexually active agrees to use adequate contraception from Screening throughout the duration of the study.
  • Has a body mass index between 18 and 34, inclusive.
  • Based on sleep history, the subject has had chronic insomnia for at least 3 months, as defined by the following:

    • The predominant complaint is difficulty initiating or maintaining sleep, or non-restorative sleep, for at least 3 months.
    • The sleep disturbance (or associated daytime fatigue) causes clinically significant distress or impairment in social, occupational, or other important areas of functioning.
    • The sleep disturbance does not occur exclusively during the course of narcolepsy, breathing-related sleep disorder, circadian rhythm sleep disorder, or parasomnia.
    • The disturbance does not occur exclusively during the course of another mental disorder (eg, major depressive disorder, generalized anxiety disorder, delirium).
    • The disturbance is not due to the direct physiological effects of a substance or a general medical condition.
  • Based on sleep history, the subject reports a history of subjective sleep latency ≥45 minutes and a subjective total sleep time ≤6.5 hours for at least 3 months.
  • Based on sleep history, the subject's habitual bedtime is between 10:00 PM and 1:00 AM.
  • On at least 3 of the first 5 nights of single blind run-in placebo treatment, the subject must have an subjective sleep latency of ≥45 minutes and a subjective total sleep time of <6.5 hours.
  • The difference of the average subjective sleep latency from first 3 nights of data in the first week of single-blind run-in to the average of the last 3 nights of data in the first week of single-blind run-in must be ≤30 minutes.
  • The difference of the average subjective sleep latency from first 3 nights of data in the first week of single-blind run-in to the average of the last 3 nights of data in the second week of single-blind run-in must be ≤30 minutes.
  • The difference of the average subjective sleep latency from first 3 nights of data in the first week of single-blind run-in to the average of the last 3 nights of data in the third week of single-blind run-in must be ≤30 minutes.
  • Is willing to have a fixed bedtime and agrees to go to bed within ± 30 minutes of the habitual bedtime during the entire study, exceptions will be allowed at weekends that are not within 2 days of a polysomnography visit.
  • Has consistent access to a touch-tone phone and is willing to complete all telephone questionnaires within 60 minutes of wake time each morning throughout the entire duration of the study.
  • Is willing to remain in bed for at least 6.5 hours each night during the entire study.
  • Based on sleep history, the subject normally uses pharmacologic assistance to sleep 0 to 4 (maximum allowable) times per week in the last 3 months. Subjects must agree to discontinue the use of all sleep aids beginning 1 week prior to the first dose of single-blind study medication and throughout the entire duration of the study.
  • The subject must complete the post-sleep questionnaire morning questionnaire on at least 5 of 7 mornings for all 3 weeks of single-blind run-in.
  • Has a mean latency to persistent sleep of ≥20 minutes on 2 consecutive screening nights, with neither night less than 15 minutes, via polysomnography screening assessment during the single-blind placebo run-in period.

Exclusion Criteria:

  • Has a known hypersensitivity to ramelteon or related compounds, including melatonin.
  • Has participated in a study involving ramelteon within 6 months of initial Screening Visit.
  • Has participated in any other investigational study and/or taken any investigational drug within 30 days or 5 half-lives (whichever is longer) prior to the first night of single-blind study medication.
  • Has sleep schedule changes required by employment (eg, shift worker) within 3 months prior to the first night of single-blind study medication, or has flown across greater than 3 time zones within 7 days prior to Screening.
  • Has participated in a weight loss program or has substantially altered his or her exercise routine within 30 days prior to the first night of single-blind study medication.
  • Has ever had a history of seizures, sleep apnea, restless leg syndrome, periodic leg movements during sleep, chronic obstructive pulmonary disease, fibromyalgia, schizophrenia, bipolar disorder, mental retardation or a cognitive disorder.
  • Has a history of psychiatric disorder (including anxiety or depression) within the past 12 months.
  • Has a history of drug addiction or alcohol abuse and/or regularly consumes 4 or more alcoholic drinks per day within the past 12 months, as defined in Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Revised.
  • Has a current significant neurological (including cognitive and psychiatric disorders), hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematological, or metabolic disease, unless currently controlled and stable with protocol-allowed medication 30 days prior to the first night of single blind study medication.
  • The subject uses tobacco products (including nicotine gum and patch) during nightly awakenings.
  • The subject has any clinically important abnormal finding as determined by a medical history, physical examination, electrocardiogram, or clinical laboratory tests, as determined by the investigator.
  • The subject is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:

    • Anxiolytics
    • Central nervous system active drugs (including herbal)
    • Hypnotics
    • Narcotic analgesics
    • Antidepressants
    • Beta-blockers
    • Anticonvulsants
    • Systemic steroids
    • Sedating H1 antihistamines
    • Respiratory stimulants
    • Muscle relaxants
    • Sedatives
    • Antipsychotics
    • Sedating decongestants
    • Kava-kava
    • St. John's wort
    • Ginkgo biloba
    • Over-the counter and prescription stimulants, diet aids and sleep aids
    • Drugs that are known or are suspected to significantly inhibit CYP450
    • Melatonin
  • Has a positive urine drug screen for an illegal substance at the initial Screening Visit.
  • Has a positive urine drug screen at polysomnography screening or a positive alcohol breathalyzer test at polysomnography screening or randomization.
  • Exhibits a placebo response during the single-blind placebo run-in period. A placebo response is defined as having:

    • a difference in average subjective sleep latency >30 minutes from first 3 nights of data in the first week of single-blind run-in to the average of the last 3 nights of data in the first week of single-blind run-in.
    • a difference in average subjective sleep latency >30 minutes from first 3 nights of data in the first week of single-blind run-in to the average of the last 3 nights of data in the second week of single-blind run-in.
    • a difference in average subjective sleep latency >30 minutes from first 3 nights of data in the first week of single-blind run-in to the average of the last 3 nights of data in the third week of single-blind run-in.
  • Has periodic leg movements during sleep with arousal index (per hour of sleep) >10 as seen on polysomnography on the first night of polysomnography screening.
  • Has any additional condition(s) that in the Investigator's opinion would:

    • Affect sleep/wake function
    • Prohibit the subject from completing the study
    • Not be in the best interest of the subject to complete the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00756002

Sponsors and Collaborators
Takeda
Investigators
Study Director: Medical Director Clinical Science Takeda
  More Information

Additional Information:
No publications provided

Responsible Party: Sr VP, Clinical Science, Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier: NCT00756002     History of Changes
Other Study ID Numbers: 01-06-TL-375-081, 2007-000403-15, U1111-1115-2084
Study First Received: September 17, 2008
Results First Received: April 3, 2009
Last Updated: May 31, 2010
Health Authority: European Union: European Medicines Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Finland: Finnish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Takeda:
Chronic Insomnia
DIMS (Disorders of Initiating and Maintaining Sleep)
Disorders of Initiating and Maintaining Sleep
Insomnia Disorder Sleep Initiation Dysfunction
Transient Insomnia
Drug Therapy
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders

ClinicalTrials.gov processed this record on July 24, 2014