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ID

25348

Description

Efficacy an Safety of Volinanserin on Sleep Maintenance Insomnia With a Sub-study on Stable Type II Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT00464061

Link

https://clinicaltrials.gov/show/NCT00464061

Keywords

Versions (1)
  1. 9/1/17 9/1/17 -
Uploaded on

September 1, 2017

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License

Creative Commons BY 4.0
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    Eligibility Sleep Initiation and Maintenance Disorders NCT00464061

    English

    Eligibility Sleep Initiation and Maintenance Disorders NCT00464061

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    diagnosis of primary insomnia based on diagnostic and statistical manual of mental disorders (fourth edition) criteria
    Description

    Primary Insomnia

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0033139
    disturbances of sleep maintenance criteria based on patient's information related to sleep pattern during the preceding month
    Description

    Sleep Initiation and Maintenance Disorders | Patient Sleep pattern

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021603
    UMLS CUI [2,1]
    C0030705
    UMLS CUI [2,2]
    C0474396
    sub-study :
    Description

    Clinical Trial Part

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0008976
    UMLS CUI [1,2]
    C0449719
    patients will be included if they have an established medical diagnosis of type ii diabetes mellitus, and have been treated either with an oral hypoglycemic agent and/or insulin for at least three months prior to the screening visit (with stable regimen for at least one month prior to screening)
    Description

    Diabetes Mellitus, Non-Insulin-Dependent | Oral hypoglycemic Dose Stable | Insulin Dose Stable

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0011860
    UMLS CUI [2,1]
    C0359086
    UMLS CUI [2,2]
    C0178602
    UMLS CUI [2,3]
    C0205360
    UMLS CUI [3,1]
    C0021641
    UMLS CUI [3,2]
    C0178602
    UMLS CUI [3,3]
    C0205360
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    females who are lactating or who are pregnant
    Description

    Breast Feeding | Pregnancy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0006147
    UMLS CUI [2]
    C0032961
    night shift workers, and individuals who nap 3 or more times per week over the preceding month
    Description

    Night shift worker | Nap Frequency

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0555008
    UMLS CUI [2,1]
    C0870935
    UMLS CUI [2,2]
    C0439603
    consumption of xanthine-containing beverages (i.e. tea, coffee, cola) comprising more than 5 cups/day
    Description

    Beverages Containing Xanthine or xanthine derivative | Tea cups/day | Coffee cups/day | Cola drink

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0005329
    UMLS CUI [1,2]
    C0332256
    UMLS CUI [1,3]
    C0043315
    UMLS CUI [2,1]
    C0039400
    UMLS CUI [2,2]
    C0560654
    UMLS CUI [3,1]
    C0009237
    UMLS CUI [3,2]
    C0560654
    UMLS CUI [4]
    C0452444
    participation in another trial having received study medication within 1 month before the screening visit
    Description

    Study Subject Participation Status | Investigational New Drugs

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    UMLS CUI [2]
    C0013230
    body mass index ≥ 33
    Description

    Body mass index

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1305855
    use of over-the-counter medications such as tryptophan, valerian root, kava, melatonin, st. john's wort, alluna or prescription sleep medication
    Description

    Drugs, Non-Prescription | Tryptophan | valerian root extract | Kava preparation | Melatonin | ST. JOHN'S WORT EXTRACT | Sleep Disorder Agents

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0013231
    UMLS CUI [2]
    C0041249
    UMLS CUI [3]
    C0795674
    UMLS CUI [4]
    C0939882
    UMLS CUI [5]
    C0025219
    UMLS CUI [6]
    C0813171
    UMLS CUI [7]
    C4020625
    use of any substance with psychotropic effects or properties know to affect sleep/wake
    Description

    Psychotropic Drugs Affecting Sleep | Psychotropic Drugs Affecting Wake

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0033978
    UMLS CUI [1,2]
    C0392760
    UMLS CUI [1,3]
    C0037313
    UMLS CUI [2,1]
    C0033978
    UMLS CUI [2,2]
    C0392760
    UMLS CUI [2,3]
    C0442696
    history of primary hypersomnia, narcolepsy, breathing-related sleep disorder, circadian rhythm sleep disorder, parasomnia, dyssomnia
    Description

    Primary Hypersomnia | Narcolepsy | Breathing-related sleep disorder | Sleep Disorders, Circadian Rhythm | Parasomnia | Dyssomnias

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0033138
    UMLS CUI [2]
    C0027404
    UMLS CUI [3]
    C0236845
    UMLS CUI [4]
    C0877792
    UMLS CUI [5]
    C0030508
    UMLS CUI [6]
    C0700201
    clinically significant, severe or unstable, acute or chronically progressive medical or surgical disorder
    Description

    Disease Severe | Disease Unstable | Progressive Disease | Progressive Disease chronic | Disease Due to Operative Surgical Procedures

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C0205082
    UMLS CUI [2,1]
    C0012634
    UMLS CUI [2,2]
    C0443343
    UMLS CUI [3]
    C1335499
    UMLS CUI [4,1]
    C1335499
    UMLS CUI [4,2]
    C0205191
    UMLS CUI [5,1]
    C0012634
    UMLS CUI [5,2]
    C0678226
    UMLS CUI [5,3]
    C0543467
    positive qualitative urine drug screen (opiates, cocaine, amphetamine…)
    Description

    Urine drug screen positive | Opiates | Cocaine | Amphetamine

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0743300
    UMLS CUI [2]
    C0376196
    UMLS CUI [3]
    C0009170
    UMLS CUI [4]
    C0002658
    the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
    Description

    Study Subject Participation Status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2348568
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    Similar models

    Eligibility Sleep Initiation and Maintenance Disorders NCT00464061

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Primary Insomnia
    Item
    diagnosis of primary insomnia based on diagnostic and statistical manual of mental disorders (fourth edition) criteria
    boolean
    C0033139 (UMLS CUI [1])
    Sleep Initiation and Maintenance Disorders | Patient Sleep pattern
    Item
    disturbances of sleep maintenance criteria based on patient's information related to sleep pattern during the preceding month
    boolean
    C0021603 (UMLS CUI [1])
    C0030705 (UMLS CUI [2,1])
    C0474396 (UMLS CUI [2,2])
    Clinical Trial Part
    Item
    sub-study :
    boolean
    C0008976 (UMLS CUI [1,1])
    C0449719 (UMLS CUI [1,2])
    Diabetes Mellitus, Non-Insulin-Dependent | Oral hypoglycemic Dose Stable | Insulin Dose Stable
    Item
    patients will be included if they have an established medical diagnosis of type ii diabetes mellitus, and have been treated either with an oral hypoglycemic agent and/or insulin for at least three months prior to the screening visit (with stable regimen for at least one month prior to screening)
    boolean
    C0011860 (UMLS CUI [1])
    C0359086 (UMLS CUI [2,1])
    C0178602 (UMLS CUI [2,2])
    C0205360 (UMLS CUI [2,3])
    C0021641 (UMLS CUI [3,1])
    C0178602 (UMLS CUI [3,2])
    C0205360 (UMLS CUI [3,3])
    Item Group
    C0680251 (UMLS CUI)
    Breast Feeding | Pregnancy
    Item
    females who are lactating or who are pregnant
    boolean
    C0006147 (UMLS CUI [1])
    C0032961 (UMLS CUI [2])
    Night shift worker | Nap Frequency
    Item
    night shift workers, and individuals who nap 3 or more times per week over the preceding month
    boolean
    C0555008 (UMLS CUI [1])
    C0870935 (UMLS CUI [2,1])
    C0439603 (UMLS CUI [2,2])
    Beverages Containing Xanthine or xanthine derivative | Tea cups/day | Coffee cups/day | Cola drink
    Item
    consumption of xanthine-containing beverages (i.e. tea, coffee, cola) comprising more than 5 cups/day
    boolean
    C0005329 (UMLS CUI [1,1])
    C0332256 (UMLS CUI [1,2])
    C0043315 (UMLS CUI [1,3])
    C0039400 (UMLS CUI [2,1])
    C0560654 (UMLS CUI [2,2])
    C0009237 (UMLS CUI [3,1])
    C0560654 (UMLS CUI [3,2])
    C0452444 (UMLS CUI [4])
    Study Subject Participation Status | Investigational New Drugs
    Item
    participation in another trial having received study medication within 1 month before the screening visit
    boolean
    C2348568 (UMLS CUI [1])
    C0013230 (UMLS CUI [2])
    Body mass index
    Item
    body mass index ≥ 33
    boolean
    C1305855 (UMLS CUI [1])
    Drugs, Non-Prescription | Tryptophan | valerian root extract | Kava preparation | Melatonin | ST. JOHN'S WORT EXTRACT | Sleep Disorder Agents
    Item
    use of over-the-counter medications such as tryptophan, valerian root, kava, melatonin, st. john's wort, alluna or prescription sleep medication
    boolean
    C0013231 (UMLS CUI [1])
    C0041249 (UMLS CUI [2])
    C0795674 (UMLS CUI [3])
    C0939882 (UMLS CUI [4])
    C0025219 (UMLS CUI [5])
    C0813171 (UMLS CUI [6])
    C4020625 (UMLS CUI [7])
    Psychotropic Drugs Affecting Sleep | Psychotropic Drugs Affecting Wake
    Item
    use of any substance with psychotropic effects or properties know to affect sleep/wake
    boolean
    C0033978 (UMLS CUI [1,1])
    C0392760 (UMLS CUI [1,2])
    C0037313 (UMLS CUI [1,3])
    C0033978 (UMLS CUI [2,1])
    C0392760 (UMLS CUI [2,2])
    C0442696 (UMLS CUI [2,3])
    Primary Hypersomnia | Narcolepsy | Breathing-related sleep disorder | Sleep Disorders, Circadian Rhythm | Parasomnia | Dyssomnias
    Item
    history of primary hypersomnia, narcolepsy, breathing-related sleep disorder, circadian rhythm sleep disorder, parasomnia, dyssomnia
    boolean
    C0033138 (UMLS CUI [1])
    C0027404 (UMLS CUI [2])
    C0236845 (UMLS CUI [3])
    C0877792 (UMLS CUI [4])
    C0030508 (UMLS CUI [5])
    C0700201 (UMLS CUI [6])
    Disease Severe | Disease Unstable | Progressive Disease | Progressive Disease chronic | Disease Due to Operative Surgical Procedures
    Item
    clinically significant, severe or unstable, acute or chronically progressive medical or surgical disorder
    boolean
    C0012634 (UMLS CUI [1,1])
    C0205082 (UMLS CUI [1,2])
    C0012634 (UMLS CUI [2,1])
    C0443343 (UMLS CUI [2,2])
    C1335499 (UMLS CUI [3])
    C1335499 (UMLS CUI [4,1])
    C0205191 (UMLS CUI [4,2])
    C0012634 (UMLS CUI [5,1])
    C0678226 (UMLS CUI [5,2])
    C0543467 (UMLS CUI [5,3])
    Urine drug screen positive | Opiates | Cocaine | Amphetamine
    Item
    positive qualitative urine drug screen (opiates, cocaine, amphetamine…)
    boolean
    C0743300 (UMLS CUI [1])
    C0376196 (UMLS CUI [2])
    C0009170 (UMLS CUI [3])
    C0002658 (UMLS CUI [4])
    Study Subject Participation Status
    Item
    the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
    boolean
    C2348568 (UMLS CUI [1])
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