0 Evaluaciones
ID

38917

Descripción

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 to be filled in continously during the study and/or at the Day 14 Follow-up evaluation and contains information on other medication the participant has received during the course of the study.

Link

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

Palabras clave

Versiones (1)
  1. 12.11.19 12.11.19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

12. November 2019

DOI

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Licencia

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

    Inglés

    Concomitant Medications

    1 formularios  
    Administrative data
    Descripción

    Administrative data

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

    Date of Visit/Assessment

    Tipo de datos

    date

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

    Study site

    Tipo de datos

    text

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

    Patient

    Tipo de datos

    text

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

    Subject No.

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Concomitant Medications
    Descripción

    Concomitant Medications

    Alias
    UMLS CUI-1
    C2347852 (Concomitant Agent)
    Sequence Number
    Descripción

    [hidden]

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2348184 (Sequence Number)
    Drug name
    Descripción

    Trade Name preferred

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2360065 (Medication name)
    LOINC
    MTHU027854
    Concomitant Medication Modified Reported Term
    Descripción

    [hidden]

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2826819 (Concomitant Medication Modified Reported Term)
    GSK Drug synonym
    Descripción

    [hidden]

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    UMLS CUI [1,2]
    C0871468 (Synonym)
    GSK Drug Collection code
    Descripción

    [hidden]

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    UMLS CUI [1,2]
    C1516698 (Collection (action))
    LOINC
    LP20988-9
    UMLS CUI [1,3]
    C0805701 (Code)
    Failed coding
    Descripción

    [hidden]

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0805701 (Code)
    UMLS CUI [1,2]
    C0231175 (Failed)
    Unit Dose
    Descripción

    Concomitant Medication Unit Dose

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2826811 (Concomitant Medication Dose)
    Units
    Descripción

    Concomitant Medication Units

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2826646 (Concomitant Medication Dose Unit)
    Frequency
    Descripción

    Concomitant Medication Frequency

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2826654 (Concomitant Medication Dose Frequency)
    Route
    Descripción

    Concomitant Medication Route

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2826730 (Concomitant Medication Route of Administration)
    Reason for Medication
    Descripción

    Concomitant Medication reason

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2826696 (Concomitant Medication Use Indication)
    Start Date and Time
    Descripción

    Concomitant Medication start date/time

    Tipo de datos

    datetime

    Alias
    UMLS CUI [1]
    C2826825 (Concomitant Medication Use Start Date Time)
    Taken Prior to Study?
    Descripción

    Concomitant Medication Taken Prior to Study?

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2826667 (Concomitant Medication Previous Occurrence)
    Ongoing?
    Descripción

    If no, specify End Date and Time

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2826666 (Concomitant Medication Ongoing)
    If no, specify End Date and Time
    Descripción

    Concomitant Medication end date/time

    Tipo de datos

    datetime

    Alias
    UMLS CUI [1]
    C2826815 (Concomitant Medication Use End Date Time)
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    Similar models

    Concomitant Medications

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    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 Group
    Concomitant Medications
    C2347852 (UMLS CUI-1)
    Sequence Number
    Item
    Sequence Number
    text
    C2348184 (UMLS CUI [1])
    Drug name
    Item
    Drug name
    text
    C2360065 (UMLS CUI [1])
    Concomitant Medication Modified Reported Term
    Item
    Concomitant Medication Modified Reported Term
    text
    C2826819 (UMLS CUI [1])
    Drug synonym
    Item
    GSK Drug synonym
    text
    C0013227 (UMLS CUI [1,1])
    C0871468 (UMLS CUI [1,2])
    Drug Collection code
    Item
    GSK Drug Collection code
    text
    C0013227 (UMLS CUI [1,1])
    C1516698 (UMLS CUI [1,2])
    C0805701 (UMLS CUI [1,3])
    Failed coding
    Item
    Failed coding
    text
    C0805701 (UMLS CUI [1,1])
    C0231175 (UMLS CUI [1,2])
    Concomitant Medication Unit Dose
    Item
    Unit Dose
    text
    C2826811 (UMLS CUI [1])
    Concomitant Medication Units
    Item
    Units
    text
    C2826646 (UMLS CUI [1])
    Concomitant Medication Frequency
    Item
    Frequency
    text
    C2826654 (UMLS CUI [1])
    Concomitant Medication Route
    Item
    Route
    text
    C2826730 (UMLS CUI [1])
    Concomitant Medication reason
    Item
    Reason for Medication
    text
    C2826696 (UMLS CUI [1])
    Concomitant Medication start date/time
    Item
    Start Date and Time
    datetime
    C2826825 (UMLS CUI [1])
    Item
    Taken Prior to Study?
    text
    C2826667 (UMLS CUI [1])
    Concomitant Medication Taken Prior to Study?
    Code List
    Taken Prior to Study?
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    Item
    Ongoing?
    text
    C2826666 (UMLS CUI [1])
    Concomitant Medication Taken Prior to Study?
    Code List
    Ongoing?
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    Concomitant Medication end date/time
    Item
    If no, specify End Date and Time
    datetime
    C2826815 (UMLS CUI [1])
    Volver a la parte superior de la página 

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