0 Valutazioni
ID

38917

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 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.

collegamento

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

Keywords

versioni (1)
  1. 12/11/19 12/11/19 -
Titolare del copyright

GlaxoSmithKline

Caricato su

12 novembre 2019

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY-NC 3.0
Commenti del modello :

Puoi commentare il modello dati qui. Tramite i fumetti nei gruppi di articoli e articoli è possibile aggiungere commenti a quelli in modo specifico.

Torna ai commenti del modello
Commenti del gruppo di articoli per :

Commenti dell'articolo per :

  • i più nuovi
  • i più vecchi
  • Popolare
  • i più nuovi
    • i più nuovi
    • i più vecchi
    • Popolare

    Non ci sono commenti

    Per scaricare i modelli di dati devi essere registrato. Per favore accesso o registrati GRATIS.

    Polysomnographic Assessment of Vestipitant for the Treatment of Primary Insomnia NCT00992160

    Inglese

    Concomitant Medications

    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)
    Site
    Descrizione

    Study site

    Tipo di dati

    text

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

    Patient

    Tipo di dati

    text

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

    Subject No.

    Tipo di dati

    text

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

    Concomitant Medications

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

    [hidden]

    Tipo di dati

    text

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

    Trade Name preferred

    Tipo di dati

    text

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

    [hidden]

    Tipo di dati

    text

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

    [hidden]

    Tipo di dati

    text

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

    [hidden]

    Tipo di dati

    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
    Descrizione

    [hidden]

    Tipo di dati

    text

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

    Concomitant Medication Unit Dose

    Tipo di dati

    text

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

    Concomitant Medication Units

    Tipo di dati

    text

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

    Concomitant Medication Frequency

    Tipo di dati

    text

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

    Concomitant Medication Route

    Tipo di dati

    text

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

    Concomitant Medication reason

    Tipo di dati

    text

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

    Concomitant Medication start date/time

    Tipo di dati

    datetime

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

    Concomitant Medication Taken Prior to Study?

    Tipo di dati

    text

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

    If no, specify End Date and Time

    Tipo di dati

    text

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

    Concomitant Medication end date/time

    Tipo di dati

    datetime

    Alias
    UMLS CUI [1]
    C2826815 (Concomitant Medication Use End Date Time)
    Ritorna all'inizio della pagina

    Similar models

    Concomitant Medications

    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])
    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])
    Ritorna all'inizio della pagina 

    Aiuto

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial