0 Ratings
ID

38888

Description

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). The purpose of this form is to record information on pharmacokinetic blood samples taken at Visits 4 through to 8 (two samples at Visits 7 and 8).

Link

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

Keywords

Versions (1)
  1. 11/12/19 11/12/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 12, 2019

DOI

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License

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

    English

    Pharmacokinetics Blood

    1 forms  
    1. StudyEvent: ODM
      1. Pharmacokinetics Blood
    Administrative Data
    Description

    Administrative Data

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

    Date of Visit/Assessment

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303 (Date of visit)
    SNOMED
    406543005
    UMLS CUI [2]
    C2985720 (Assessment Date)
    Site
    Description

    Study site

    Data type

    text

    Alias
    UMLS CUI [1]
    C2825164 (Study Site)
    Patient
    Description

    Patient

    Data type

    text

    Alias
    UMLS CUI [1]
    C1299487 (Patient name)
    SNOMED
    371484003
    Patient No.
    Description

    Subject No.

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Study Visit
    Description

    Type of Visit

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0545082 (Visit)
    UMLS CUI [1,2]
    C0332307 (Type - attribute)
    SNOMED
    261664005
    Dosing Date and Time
    Description

    Dosing Date and Time

    Alias
    UMLS CUI-1
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    UMLS CUI-2
    C0178602 (Dosage)
    SNOMED
    260911001
    LOINC
    LP7180-5
    UMLS CUI-3
    C1264639 (Date/Time)
    SNOMED
    118575009
    Dosing date/time
    Description

    Dosing date/time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    UMLS CUI [1,2]
    C0178602 (Dosage)
    SNOMED
    260911001
    LOINC
    LP7180-5
    UMLS CUI [1,3]
    C1264639 (Date/Time)
    SNOMED
    118575009
    Pharmacokinetics Blood
    Description

    Pharmacokinetics Blood

    Alias
    UMLS CUI-1
    C0031328 (Pharmacokinetic aspects)
    UMLS CUI-2
    C0005767 (Blood)
    SNOMED
    87612001
    LOINC
    LP71680-0
    Scheduled Time
    Description

    At Visit 4 and 5, select "10h". At Visit 6, select "Visit". At Visit 7 and 8, fill in entire itemgroup both for "Pre-dose" and "10h".

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0005834 (Collection of blood specimen for laboratory procedure)
    SNOMED
    82078001
    LOINC
    LP125037-4
    UMLS CUI [1,2]
    C0031328 (Pharmacokinetic aspects)
    UMLS CUI [1,3]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    UMLS CUI [1,4]
    C1301732 (Planned)
    SNOMED
    397943006
    LOINC
    LA20099-0
    Actual date/time
    Description

    Date/time of pharmacokinetic blood sample

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0005834 (Collection of blood specimen for laboratory procedure)
    SNOMED
    82078001
    LOINC
    LP125037-4
    UMLS CUI [1,2]
    C0031328 (Pharmacokinetic aspects)
    UMLS CUI [1,3]
    C1264639 (Date/Time)
    SNOMED
    118575009
    Sample identifier
    Description

    Pharmacokinetic blood sample identifier

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0005834 (Collection of blood specimen for laboratory procedure)
    SNOMED
    82078001
    LOINC
    LP125037-4
    UMLS CUI [1,2]
    C0031328 (Pharmacokinetic aspects)
    UMLS CUI [1,3]
    C1299222 (Sample identification number)
    SNOMED
    372274003
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    Similar models

    Pharmacokinetics Blood

    1 forms
    1. StudyEvent: ODM
      1. Pharmacokinetics Blood
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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])
    Study site
    Item
    Site
    text
    C2825164 (UMLS CUI [1])
    Patient
    Item
    Patient
    text
    C1299487 (UMLS CUI [1])
    Subject No.
    Item
    Patient No.
    text
    C2348585 (UMLS CUI [1])
    Item
    Study Visit
    text
    C0545082 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    Type of Visit
    Code List
    Study Visit
    CL Item
    Visit 4 (Visit 4)
    CL Item
    Visit 5 (Visit 5)
    CL Item
    Visit 6 (Visit 6)
    CL Item
    Visit 7 (Visit 7)
    CL Item
    Visit 8 (Visit 8)
    Item Group
    Dosing Date and Time
    C0013227 (UMLS CUI-1)
    C0178602 (UMLS CUI-2)
    C1264639 (UMLS CUI-3)
    Dosing date/time
    Item
    Dosing date/time
    datetime
    C0013227 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C1264639 (UMLS CUI [1,3])
    Item Group
    Pharmacokinetics Blood
    C0031328 (UMLS CUI-1)
    C0005767 (UMLS CUI-2)
    Item
    Scheduled Time
    text
    C0005834 (UMLS CUI [1,1])
    C0031328 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    C1301732 (UMLS CUI [1,4])
    Scheduled time of pharmacokinetic blood sample
    Code List
    Scheduled Time
    CL Item
    10h (10h)
    CL Item
    Visit (Visit)
    CL Item
    Pre-dose (Pre-dose)
    Date/time of pharmacokinetic blood sample
    Item
    Actual date/time
    datetime
    C0005834 (UMLS CUI [1,1])
    C0031328 (UMLS CUI [1,2])
    C1264639 (UMLS CUI [1,3])
    Pharmacokinetic blood sample identifier
    Item
    Sample identifier
    text
    C0005834 (UMLS CUI [1,1])
    C0031328 (UMLS CUI [1,2])
    C1299222 (UMLS CUI [1,3])
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