0 Beoordelingen
ID

39866

Beschrijving

Study ID: 110399 Clinical Study ID: 110399 Study Title: A randomized, double blind, parallel group, placebo controlled 28 day study to investigate the safety, tolerability and pharmacodynamics of SB-656933 in subjects with cystic fibrosis. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00903201 https://clinicaltrials.gov/ct2/show/NCT00903201?term=NCT00903201 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: SB656933, Placebo Trade Name: N/A Study Indication: Cystic Fibrosis The study consists of a screening, five study visits and a follow-up (time relative to Baseline in days): Visit 1: Screening, Day -28 to -16 Visit 2a: Day -7 to -4 Visit 2b: Day 1 Visit 3: Day 14 Visit 4: Day 21 Visit 5: Day 28 Visit 6: Early Withdrawal/ Follow-up, Day 35 to 42. From day 1 to day 28 the patients will receive daily doses. This document contains the Pharmacodynamics and Pharmacokinetics Blood form. It has to be filled in for V2b, V3, V5 and if required for logs/ repeats.

Link

https://clinicaltrials.gov/ct2/show/NCT00903201?term=NCT00903201

Trefwoorden

Versies (2)
  1. 19-02-20 19-02-20 -
  2. 25-02-20 25-02-20 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

25 februari 2020

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 4.0
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.

    Safety, tolerability and pharmacodynamics of Elubrixin in cystic fibrosis patients, NCT00903201

    Engels

    Pharmacodynamics, Pharmacokinetics Blood

    1 Formulieren  
    Administrative data
    Beschrijving

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject Number
    Beschrijving

    Subject Number

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Date of Visit
    Beschrijving

    day month year

    Datatype

    date

    Alias
    UMLS CUI [1]
    C1320303
    Visit type
    Beschrijving

    Please note for which visit you will fill in this document.

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C0332307
    Dosing Date
    Beschrijving

    day month year

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0178602
    UMLS CUI [1,2]
    C0011008
    Dosing Time
    Beschrijving

    00:00-23:59

    Datatype

    time

    Alias
    UMLS CUI [1,1]
    C0178602
    UMLS CUI [1,2]
    C0040223
    Pharmacodynamics/ biomarkers
    Beschrijving

    Pharmacodynamics/ biomarkers

    Alias
    UMLS CUI-1
    C0851347
    UMLS CUI-2
    C0005516
    Time relative to dosage
    Beschrijving

    If you will fill in this form for logs/ repeats, tick "Repeat". For all other visits tick "Pre-Dose".

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0439564
    UMLS CUI [1,2]
    C0178602
    Date of sample
    Beschrijving

    day month year

    Datatype

    date

    Alias
    UMLS CUI [1]
    C1302413
    Time of sample
    Beschrijving

    00:00-23:59

    Datatype

    time

    Alias
    UMLS CUI [1]
    C4064021
    Sample ID
    Beschrijving

    Only to be filled in for logs/ repeats.

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C1299222
    Pharmacokinetics Blood
    Beschrijving

    Pharmacokinetics Blood

    Alias
    UMLS CUI-1
    C0031328
    UMLS CUI-2
    C0005767
    Time relative to dosage
    Beschrijving

    For Visit 2b all timepoints have to be filled in. For Visit 3 only Pre-Dose has to be filled in. For Visit 5 only Pre-Dose, 1 Hr and 4 Hr have to be filled in. If you will fill in this form for logs/ repeats, tick "Repeat".

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0439564
    UMLS CUI [1,2]
    C0178602
    Actual Date
    Beschrijving

    day month year

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0031328
    UMLS CUI [1,3]
    C0005767
    Actual Time
    Beschrijving

    00:00-23:59

    Datatype

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0031328
    UMLS CUI [1,3]
    C0005767
    Sample ID
    Beschrijving

    Only to be filled in for logs/ repeats.

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C1299222
    Terug naar het begin van de pagina

    Similar models

    Pharmacodynamics, Pharmacokinetics Blood

    1 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Subject Number
    Item
    Subject Number
    integer
    C2348585 (UMLS CUI [1])
    Date of Visit
    Item
    Date of Visit
    date
    C1320303 (UMLS CUI [1])
    Item
    Visit type
    integer
    C0545082 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    Visit type
    Code List
    Visit type
    CL Item
    V2b (1)
    CL Item
    V3 (2)
    CL Item
    V5 (3)
    CL Item
    Logs/ Repeats (4)
    Dosing Date
    Item
    Dosing Date
    date
    C0178602 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Dosing Time
    Item
    Dosing Time
    time
    C0178602 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Item Group
    Pharmacodynamics/ biomarkers
    C0851347 (UMLS CUI-1)
    C0005516 (UMLS CUI-2)
    Item
    Time relative to dosage
    integer
    C0439564 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    Time relative to dosage
    Code List
    Time relative to dosage
    CL Item
    Pre-Dose (1)
    CL Item
    Repeat (2)
    Date of sample
    Item
    Date of sample
    date
    C1302413 (UMLS CUI [1])
    Time of sample
    Item
    Time of sample
    time
    C4064021 (UMLS CUI [1])
    Item
    Sample ID
    integer
    C1299222 (UMLS CUI [1])
    Sample ID
    Code List
    Sample ID
    CL Item
    901 (1)
    CL Item
    902 (2)
    CL Item
    903 (3)
    CL Item
    904 (4)
    CL Item
    905 (5)
    CL Item
    906 (6)
    CL Item
    907 (7)
    CL Item
    908 (8)
    CL Item
    909 (9)
    CL Item
    910 (10)
    CL Item
    911 (11)
    CL Item
    912 (12)
    CL Item
    913 (13)
    CL Item
    914 (14)
    CL Item
    915 (15)
    Item Group
    Pharmacokinetics Blood
    C0031328 (UMLS CUI-1)
    C0005767 (UMLS CUI-2)
    Item
    Time relative to dosage
    integer
    C0439564 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    Time relative to dosage
    Code List
    Time relative to dosage
    CL Item
    Pre-Dose (1)
    CL Item
    30 Mins (2)
    CL Item
    1 Hr (3)
    CL Item
    2 Hr (4)
    CL Item
    4 Hr (5)
    CL Item
    8 Hr (6)
    CL Item
    Repeat (7)
    Actual Date, pharmacokinetics
    Item
    Actual Date
    date
    C0011008 (UMLS CUI [1,1])
    C0031328 (UMLS CUI [1,2])
    C0005767 (UMLS CUI [1,3])
    Actual Time, pharmacokinetics
    Item
    Actual Time
    time
    C0040223 (UMLS CUI [1,1])
    C0031328 (UMLS CUI [1,2])
    C0005767 (UMLS CUI [1,3])
    Item
    Sample ID
    integer
    C1299222 (UMLS CUI [1])
    Sample ID
    Code List
    Sample ID
    CL Item
    901 (1)
    CL Item
    902 (2)
    CL Item
    903 (3)
    CL Item
    904 (4)
    CL Item
    905 (5)
    CL Item
    906 (6)
    CL Item
    907 (7)
    CL Item
    908 (8)
    CL Item
    909 (9)
    CL Item
    910 (10)
    CL Item
    911 (11)
    CL Item
    912 (12)
    CL Item
    913 (13)
    CL Item
    914 (14)
    CL Item
    915 (15)
    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