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38939

Descrizione

Study ID: 111364 Clinical Study ID: 111364 Study Title: A 28-Day, Polysomnographic and subjective assessment of Vestipitant (15mg/day) for the treatment of Primary Insomnia in adult Outpatients Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00992160 Clinicaltrials.gov Links: https://clinicaltrials.gov/ct2/show/NCT00992160 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Vestipitant, Placebo Trade Name: N/A Study Indication: Primary Insomnia, Sleep Disorders This phase II, placebo-controlled, double-blind trial studies the polysomnographic and subjective effect of the neurokinin (NK1) antagonist vestipitant (15mg/day at bedtime) for the treatment of primary insomnia in adult outpatients over a period of four weeks. The study consists of a clinical Screening Visit (Visit 1), up to 21 days before investigational product/placebo initiation, two screening polysomnographies (Visits 2 and 3), followed by a placebo run-in until Visit 4, at which the subject is randomized to vestipitant or placebo, taken every night for 28 days. On Day 1 and 2 (Visits 4 and 5), polysomnographies are performed. Visit 6 is a safety visit on Day 15. On Day 27 and 28, Visits 7 and 8 are performed, which again include polysomnography studies. Subjects then undergo a 7 to 10 day placebo run-out period and have Day 7 and Day 14 Follow-Up Visit (Visits 9 and 10). This form is used to calculate the subject's mean habitual bedtime from their bedtime diary, to decide when the investigational product is to be taken (60 minutes before habitual bedtime). This form is filled in at least 8 days after the Screening Visit (Visit 1), and before Visit 2.

collegamento

https://clinicaltrials.gov/ct2/show/NCT00992160

Keywords

versioni (3)
  1. 14/11/19 14/11/19 -
  2. 14/11/19 14/11/19 -
  3. 15/11/19 15/11/19 - Sarah Riepenhausen
Titolare del copyright

GlaxoSmithKline

Caricato su

14 novembre 2019

DOI

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Licenza

Creative Commons BY-NC 3.0
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    Polysomnographic Assessment of Vestipitant for the Treatment of Primary Insomnia NCT00992160

    Inglese

    Bedtime Diary - Worksheet for Investigators

    1 moduli  
    Administrative Data
    Descrizione

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Date of Visit/Assessment
    Descrizione

    Date of Visit/Assessment

    Tipo di dati

    date

    Alias
    UMLS CUI [1]
    C1320303 (Date of visit)
    SNOMED
    406543005
    UMLS CUI [2]
    C2985720 (Assessment Date)
    Subject Identifier
    Descrizione

    Subject Identifier

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Subject Bedtime Diary
    Descrizione

    Subject Bedtime Diary

    Alias
    UMLS CUI-1
    C3890583 (Subject Diary)
    UMLS CUI-2
    C0521112 (Bedtime (qualifier value))
    SNOMED
    21029003
    Day No.
    Descrizione

    Fill in itemgroup for seven days.

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C3890583 (Subject Diary)
    UMLS CUI [1,2]
    C0439228 (day)
    SNOMED
    258703001
    UMLS CUI [1,3]
    C0750480 (Count)
    Date
    Descrizione

    Diary Entry Date

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C3890583 (Subject Diary)
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    Time (Lights-Out Last Night)
    Descrizione

    The "DE:GER (Germany/German)" version of this form uses 24hr format.

    Tipo di dati

    time

    Alias
    UMLS CUI [1,1]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    UMLS CUI [1,2]
    C4740612 (Deactivate)
    LOINC
    LA29300-3
    UMLS CUI [1,3]
    C0392223 (Lights, manufactured)
    SNOMED
    34160005
    UMLS CUI [1,4]
    C0205156 (Previous)
    SNOMED
    9130008
    LOINC
    LP21061-4
    UMLS CUI [1,5]
    C0240526 (Night time)
    SNOMED
    2546009
    LOINC
    LA25005-2
    AM/PM
    Descrizione

    The "DE:GER (Germany/German)" version of this form uses 24hr format, and this item is not included in that form.

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C1521902 (To specify)
    UMLS CUI [1,2]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    Bedtimes ranked chronologically
    Descrizione

    Bedtimes ranked chronologically

    Alias
    UMLS CUI-1
    C0521112 (Bedtime (qualifier value))
    SNOMED
    21029003
    UMLS CUI-2
    C1705176 (Order (arrangement))
    Bedtime No.
    Descrizione

    Bedtime No.

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C0521112 (Bedtime (qualifier value))
    SNOMED
    21029003
    UMLS CUI [1,2]
    C0750480 (Count)
    Bedtime
    Descrizione

    Bedtime

    Tipo di dati

    time

    Alias
    UMLS CUI [1]
    C0521112 (Bedtime (qualifier value))
    SNOMED
    21029003
    Median Habitual Bedtime
    Descrizione

    Median Habitual Bedtime

    Alias
    UMLS CUI-1
    C2348143 (Sample Mean)
    UMLS CUI-2
    C0205353 (Habitual)
    SNOMED
    40451002
    UMLS CUI-3
    C0521112 (Bedtime (qualifier value))
    SNOMED
    21029003
    UMLS CUI-4
    C1441506 (Calculation)
    SNOMED
    702873001
    LOINC
    LP6168-1
    Median Habitual Bedtime
    Descrizione

    Median of odd number of bedtimes is the bedtime (non-rounded) with equal number of earlier and later times after ranking chronologically; median of even number of bedtimes is mean of 2 middle times after ranking.

    Tipo di dati

    time

    Alias
    UMLS CUI [1,1]
    C2348143 (Sample Mean)
    UMLS CUI [1,2]
    C0205353 (Habitual)
    SNOMED
    40451002
    UMLS CUI [1,3]
    C0521112 (Bedtime (qualifier value))
    SNOMED
    21029003
    Median Habitual Bedtime rounded to nearest quarter hour
    Descrizione

    Call the subject back to schedule the date and time of their arrival at the clinic for their first PSG screening visit. Note: Subjects are to arrive at the clinic in the evening no less than 2 hours before receiving study medication, which is taken 60 minutes before the Median Habitual Bedtime (determined from the Subject Bedtime Diary calculations).

    Tipo di dati

    time

    Alias
    UMLS CUI [1,1]
    C2348143 (Sample Mean)
    UMLS CUI [1,2]
    C0205353 (Habitual)
    SNOMED
    40451002
    UMLS CUI [1,3]
    C0521112 (Bedtime (qualifier value))
    SNOMED
    21029003
    Median calculated by
    Descrizione

    Print Name

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C2348143 (Sample Mean)
    UMLS CUI [1,2]
    C0205353 (Habitual)
    SNOMED
    40451002
    UMLS CUI [1,3]
    C0521112 (Bedtime (qualifier value))
    SNOMED
    21029003
    UMLS CUI [1,4]
    C1441506 (Calculation)
    SNOMED
    702873001
    LOINC
    LP6168-1
    UMLS CUI [1,5]
    C2826892 (Investigator Name)
    Signature
    Descrizione

    Signature of Investigator calculating Median Habitual Bedtime

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C2348143 (Sample Mean)
    UMLS CUI [1,2]
    C0205353 (Habitual)
    SNOMED
    40451002
    UMLS CUI [1,3]
    C0521112 (Bedtime (qualifier value))
    SNOMED
    21029003
    UMLS CUI [1,4]
    C1441506 (Calculation)
    SNOMED
    702873001
    LOINC
    LP6168-1
    UMLS CUI [1,5]
    C2346576 (Investigator Signature)
    Date Completed
    Descrizione

    Date of Median Habitual Bedtime Calculation

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,2]
    C2348143 (Sample Mean)
    UMLS CUI [1,3]
    C0205353 (Habitual)
    SNOMED
    40451002
    UMLS CUI [1,4]
    C0521112 (Bedtime (qualifier value))
    SNOMED
    21029003
    UMLS CUI [1,5]
    C1441506 (Calculation)
    SNOMED
    702873001
    LOINC
    LP6168-1
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    Similar models

    Bedtime Diary - Worksheet for Investigators

    1 moduli
    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Date of Visit/Assessment
    Item
    Date of Visit/Assessment
    date
    C1320303 (UMLS CUI [1])
    C2985720 (UMLS CUI [2])
    Subject Identifier
    Item
    Subject Identifier
    text
    C2348585 (UMLS CUI [1])
    Item Group
    Subject Bedtime Diary
    C3890583 (UMLS CUI-1)
    C0521112 (UMLS CUI-2)
    Item
    Day No.
    integer
    C3890583 (UMLS CUI [1,1])
    C0439228 (UMLS CUI [1,2])
    C0750480 (UMLS CUI [1,3])
    Diary Entry Count
    Code List
    Day No.
    CL Item
    1 (1)
    CL Item
    2 (2)
    CL Item
    3 (3)
    CL Item
    4 (4)
    CL Item
    5 (5)
    CL Item
    6 (6)
    CL Item
    7 (7)
    Diary Entry Date
    Item
    Date
    date
    C3890583 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Time of lights-out previous night
    Item
    Time (Lights-Out Last Night)
    time
    C0040223 (UMLS CUI [1,1])
    C4740612 (UMLS CUI [1,2])
    C0392223 (UMLS CUI [1,3])
    C0205156 (UMLS CUI [1,4])
    C0240526 (UMLS CUI [1,5])
    Item
    AM/PM
    text
    C1521902 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Time specification: AM/PM
    Code List
    AM/PM
    CL Item
    AM (AM)
    CL Item
    PM (PM)
    Item Group
    Bedtimes ranked chronologically
    C0521112 (UMLS CUI-1)
    C1705176 (UMLS CUI-2)
    Item
    Bedtime No.
    text
    C0521112 (UMLS CUI [1,1])
    C0750480 (UMLS CUI [1,2])
    Bedtime No.
    Code List
    Bedtime No.
    CL Item
    1 (1)
    CL Item
    2 (2)
    CL Item
    3 (3)
    CL Item
    4 (4)
    CL Item
    5 (5)
    CL Item
    6 (6)
    CL Item
    7 (7)
    Bedtime
    Item
    Bedtime
    time
    C0521112 (UMLS CUI [1])
    Item Group
    Median Habitual Bedtime
    C2348143 (UMLS CUI-1)
    C0205353 (UMLS CUI-2)
    C0521112 (UMLS CUI-3)
    C1441506 (UMLS CUI-4)
    Median Habitual Bedtime
    Item
    Median Habitual Bedtime
    time
    C2348143 (UMLS CUI [1,1])
    C0205353 (UMLS CUI [1,2])
    C0521112 (UMLS CUI [1,3])
    Median Habitual Bedtime rounded
    Item
    Median Habitual Bedtime rounded to nearest quarter hour
    time
    C2348143 (UMLS CUI [1,1])
    C0205353 (UMLS CUI [1,2])
    C0521112 (UMLS CUI [1,3])
    Name of Investigator calculating Median Habitual Bedtime
    Item
    Median calculated by
    text
    C2348143 (UMLS CUI [1,1])
    C0205353 (UMLS CUI [1,2])
    C0521112 (UMLS CUI [1,3])
    C1441506 (UMLS CUI [1,4])
    C2826892 (UMLS CUI [1,5])
    Signature of Investigator calculating Median Habitual Bedtime
    Item
    Signature
    text
    C2348143 (UMLS CUI [1,1])
    C0205353 (UMLS CUI [1,2])
    C0521112 (UMLS CUI [1,3])
    C1441506 (UMLS CUI [1,4])
    C2346576 (UMLS CUI [1,5])
    Date of Median Habitual Bedtime Calculation
    Item
    Date Completed
    date
    C0011008 (UMLS CUI [1,1])
    C2348143 (UMLS CUI [1,2])
    C0205353 (UMLS CUI [1,3])
    C0521112 (UMLS CUI [1,4])
    C1441506 (UMLS CUI [1,5])
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