0 Bedömningar
ID

38937

Beskrivning

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.

Länk

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

Nyckelord

Versioner (3)
  1. 2019-11-14 2019-11-14 -
  2. 2019-11-14 2019-11-14 -
  3. 2019-11-15 2019-11-15 - Sarah Riepenhausen
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

14 november 2019

DOI

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Licens

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

    Engelsk

    Bedtime Diary - Worksheet for Investigators

    1 Formulär  
    Administrative Data
    Beskrivning

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Date of Visit/Assessment
    Beskrivning

    Date of Visit/Assessment

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C1320303
    UMLS CUI [2]
    C2985720
    Subject Identifier
    Beskrivning

    Subject Identifier

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2348585
    Subject Bedtime Diary
    Beskrivning

    Subject Bedtime Diary

    Alias
    UMLS CUI-1
    C3890583
    UMLS CUI-2
    C0521112
    Day No.
    Beskrivning

    Fill in itemgroup for seven days.

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C3890583
    UMLS CUI [1,2]
    C0439228
    UMLS CUI [1,3]
    C0750480
    Date
    Beskrivning

    Record the date that you went to bed using a Day Month Year format (for example, 21 OCT 05). If you go to bed after midnight, be sure to record the next day's date.

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C3890583
    UMLS CUI [1,2]
    C0011008
    Time (Lights-Out Last Night)
    Beskrivning

    Record the time you went to bed and tick if it is AM or PM in next item.

    Datatyp

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C4740612
    UMLS CUI [1,3]
    C0392223
    UMLS CUI [1,4]
    C0205156
    UMLS CUI [1,5]
    C0240526
    AM/PM
    Beskrivning

    Time specification: AM/PM

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C1521902
    UMLS CUI [1,2]
    C0040223
    Bedtimes ranked chronologically
    Beskrivning

    Bedtimes ranked chronologically

    Alias
    UMLS CUI-1
    C0521112
    UMLS CUI-2
    C1705176
    Bedtime No.
    Beskrivning

    Bedtime No.

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0521112
    UMLS CUI [1,2]
    C0750480
    Bedtime
    Beskrivning

    Bedtime

    Datatyp

    time

    Alias
    UMLS CUI [1]
    C0521112
    Median Habitual Bedtime
    Beskrivning

    Median Habitual Bedtime

    Alias
    UMLS CUI-1
    C2348143
    UMLS CUI-2
    C0205353
    UMLS CUI-3
    C0521112
    UMLS CUI-4
    C1441506
    Median Habitual Bedtime
    Beskrivning

    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.

    Datatyp

    time

    Alias
    UMLS CUI [1,1]
    C2348143
    UMLS CUI [1,2]
    C0205353
    UMLS CUI [1,3]
    C0521112
    Median Habitual Bedtime rounded to nearest quarter hour
    Beskrivning

    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).

    Datatyp

    time

    Alias
    UMLS CUI [1,1]
    C2348143
    UMLS CUI [1,2]
    C0205353
    UMLS CUI [1,3]
    C0521112
    Median calculated by
    Beskrivning

    Print Name

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C2348143
    UMLS CUI [1,2]
    C0205353
    UMLS CUI [1,3]
    C0521112
    UMLS CUI [1,4]
    C1441506
    UMLS CUI [1,5]
    C2826892
    Signature
    Beskrivning

    Signature of Investigator calculating Median Habitual Bedtime

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C2348143
    UMLS CUI [1,2]
    C0205353
    UMLS CUI [1,3]
    C0521112
    UMLS CUI [1,4]
    C1441506
    UMLS CUI [1,5]
    C2346576
    Date Completed
    Beskrivning

    Date of Median Habitual Bedtime Calculation

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C2348143
    UMLS CUI [1,3]
    C0205353
    UMLS CUI [1,4]
    C0521112
    UMLS CUI [1,5]
    C1441506
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    Similar models

    Bedtime Diary - Worksheet for Investigators

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    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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