0 Beoordelingen
ID

38910

Beschrijving

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 at the end of the study (regular Day 14 Follow-up or study discontinuation) and lists whether any repeated/additional investigations were performed and/or whether certain events occured in the participant, such as (Non-)Serious Adverse Events. Details about the investigations/events are recorded in different forms.

Link

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

Trefwoorden

Versies (2)
  1. 12-11-19 12-11-19 -
  2. 12-11-19 12-11-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

12 november 2019

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

  • Nieuwste
  • Oudste
  • Populair
  • Nieuwste
    • Nieuwste
    • Oudste
    • Populair

    Geen commentaren

    U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

    Polysomnographic Assessment of Vestipitant for the Treatment of Primary Insomnia NCT00992160

    Engels

    Logs and Repeats

    1 Formulieren  
    1. StudyEvent: ODM
      1. Logs and Repeats
    Administrative Data
    Beschrijving

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Site
    Beschrijving

    Study site

    Datatype

    text

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

    Patient

    Datatype

    text

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

    Subject No.

    Datatype

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Date of visit/assessment
    Beschrijving

    Date of visit/assessment

    Alias
    UMLS CUI-1
    C1320303 (Date of visit)
    SNOMED
    406543005
    UMLS CUI-2
    C2985720 (Assessment Date)
    Date of Visit/Assessment
    Beschrijving

    Date is the start of the study for this subject

    Datatype

    date

    Alias
    UMLS CUI [1]
    C1320303 (Date of visit)
    SNOMED
    406543005
    UMLS CUI [2]
    C2985720 (Assessment Date)
    Adverse Event/Concomitant Medication/Repeat Assessment Check Questions
    Beschrijving

    Adverse Event/Concomitant Medication/Repeat Assessment Check Questions

    Alias
    UMLS CUI-1
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    UMLS CUI-2
    C2347852 (Concomitant Agent)
    UMLS CUI-3
    C0205341 (Repeat)
    SNOMED
    27582007
    UMLS CUI-4
    C0220825 (Evaluation)
    LOINC
    LP36377-7
    Were any concomitant medications taken by the subject during the study?
    Beschrijving

    Concomitant medication

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C2347852 (Concomitant Agent)
    Did the subject experience any non-serious adverse events during the study?
    Beschrijving

    Non-serious adverse events

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1518404 (Non-serious Adverse Event)
    Did the subject experience any serious adverse events during the study?
    Beschrijving

    Serious adverse events

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1519255 (Serious Adverse Event)
    Were any repeat haematology or clinical chemistry samples taken?
    Beschrijving

    Repeat haematology or clinical chemistry samples taken

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0008000 (Chemistry, Clinical)
    UMLS CUI [1,2]
    C0200345 (Specimen Collection)
    SNOMED
    17636008
    UMLS CUI [1,3]
    C0205341 (Repeat)
    SNOMED
    27582007
    UMLS CUI [2,1]
    C0018941 (Hematologic Tests)
    SNOMED
    252275004
    UMLS CUI [2,2]
    C0200345 (Specimen Collection)
    SNOMED
    17636008
    UMLS CUI [2,3]
    C0205341 (Repeat)
    SNOMED
    27582007
    Were any repeat urinalysis samples taken?
    Beschrijving

    Repeat urinalysis samples

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0200345 (Specimen Collection)
    SNOMED
    17636008
    UMLS CUI [1,2]
    C0205341 (Repeat)
    SNOMED
    27582007
    UMLS CUI [1,3]
    C0042014 (Urinalysis)
    SNOMED
    167217005
    LOINC
    LP32744-2
    Were any repeat ECGs performed?
    Beschrijving

    Repeat ECGs

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0013798 (Electrocardiogram)
    LOINC
    LP149975-7
    UMLS CUI [1,2]
    C0205341 (Repeat)
    SNOMED
    27582007
    Were any repeat vital signs recorded?
    Beschrijving

    Repeat vital signs

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0205341 (Repeat)
    SNOMED
    27582007
    UMLS CUI [1,2]
    C0518766 (Vital signs)
    LOINC
    LP30605-7
    Did the subject experience any possible suicidality-related adverse events during the study?
    Beschrijving

    Possible suicidality-related adverse event

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    UMLS CUI [1,2]
    C2732635 (Possible clinical finding)
    SNOMED
    443859009
    UMLS CUI [1,3]
    C3166387 (Suicidality)
    LOINC
    LP121701-9
    Liver Event
    Beschrijving

    Liver Event

    Alias
    UMLS CUI-1
    C0023884 (Liver)
    SNOMED
    10200004
    LOINC
    LP29289-3
    UMLS CUI-2
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
    Beschrijving

    If Yes to Liver Events, complete the Liver Event forms

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0232741 (Liver function)
    SNOMED
    79036002
    LOINC
    LP31397-0
    UMLS CUI [1,2]
    C0008000 (Chemistry, Clinical)
    UMLS CUI [1,3]
    C0587081 (Laboratory test finding)
    SNOMED
    118246004
    UMLS CUI [1,4]
    C0304229 (Experimental drug)
    UMLS CUI [1,5]
    C2746065 (Stop (qualifier value))
    SNOMED
    422117008
    UMLS CUI [1,6]
    C0243161 (criteria)
    Terug naar het begin van de pagina

    Similar models

    Logs and Repeats

    1 Formulieren
    1. StudyEvent: ODM
      1. Logs and Repeats
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    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
    Date of visit/assessment
    C1320303 (UMLS CUI-1)
    C2985720 (UMLS CUI-2)
    Date of Visit/Assessment
    Item
    Date of Visit/Assessment
    date
    C1320303 (UMLS CUI [1])
    C2985720 (UMLS CUI [2])
    Item Group
    Adverse Event/Concomitant Medication/Repeat Assessment Check Questions
    C0877248 (UMLS CUI-1)
    C2347852 (UMLS CUI-2)
    C0205341 (UMLS CUI-3)
    C0220825 (UMLS CUI-4)
    Concomitant medication
    Item
    Were any concomitant medications taken by the subject during the study?
    boolean
    C2347852 (UMLS CUI [1])
    Non-serious adverse events
    Item
    Did the subject experience any non-serious adverse events during the study?
    boolean
    C1518404 (UMLS CUI [1])
    Serious adverse events
    Item
    Did the subject experience any serious adverse events during the study?
    boolean
    C1519255 (UMLS CUI [1])
    Repeat haematology or clinical chemistry samples taken
    Item
    Were any repeat haematology or clinical chemistry samples taken?
    boolean
    C0008000 (UMLS CUI [1,1])
    C0200345 (UMLS CUI [1,2])
    C0205341 (UMLS CUI [1,3])
    C0018941 (UMLS CUI [2,1])
    C0200345 (UMLS CUI [2,2])
    C0205341 (UMLS CUI [2,3])
    Repeat urinalysis samples
    Item
    Were any repeat urinalysis samples taken?
    boolean
    C0200345 (UMLS CUI [1,1])
    C0205341 (UMLS CUI [1,2])
    C0042014 (UMLS CUI [1,3])
    Repeat ECGs
    Item
    Were any repeat ECGs performed?
    boolean
    C0013798 (UMLS CUI [1,1])
    C0205341 (UMLS CUI [1,2])
    Repeat vital signs
    Item
    Were any repeat vital signs recorded?
    boolean
    C0205341 (UMLS CUI [1,1])
    C0518766 (UMLS CUI [1,2])
    Possible suicidality-related adverse event
    Item
    Did the subject experience any possible suicidality-related adverse events during the study?
    boolean
    C0877248 (UMLS CUI [1,1])
    C2732635 (UMLS CUI [1,2])
    C3166387 (UMLS CUI [1,3])
    Item Group
    Liver Event
    C0023884 (UMLS CUI-1)
    C0877248 (UMLS CUI-2)
    Liver chemistry results reached investigational product stopping criteria
    Item
    Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
    boolean
    C0232741 (UMLS CUI [1,1])
    C0008000 (UMLS CUI [1,2])
    C0587081 (UMLS CUI [1,3])
    C0304229 (UMLS CUI [1,4])
    C2746065 (UMLS CUI [1,5])
    C0243161 (UMLS CUI [1,6])
    Terug naar het begin van de pagina 

    Help

    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