0 Evaluaciones
ID

33162

Descripción

Study ID: 107806 Clinical Study ID: RA3107806 Study Title: An open label study to determine the safety, tolerability, excretion balance and pharmacokinetics of Losmapimod, administered as a single dose of an oral solution to healthy adult male subjects Patient Level Data: Clinicaltrials.gov Identifier: NCT00599612 https://clinicaltrials.gov/ct2/show/NCT00599612 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: losmapimod Trade Name: losmapimod Study Indication: Pulmonary Disease, Chronic Obstructive The study consists of a screening, study visit and follow-up. The protocol identifier for all: RA3107806 This document contains: 1)alcohol intake form. It has to be filled in for screening. 2)alcohol breath test form. It has to be filled in for screening and study visit. 3) drug screen form. It has to be filled in for screening and study visit.

Link

https://clinicaltrials.gov/ct2/show/NCT00599612

Palabras clave

Versiones (2)
  1. 28/11/18 28/11/18 -
  2. 30/11/18 30/11/18 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

30 de noviembre de 2018

DOI

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Licencia

Creative Commons BY-NC 3.0
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    Safety, tolerability, excretion balance and pharmacokinetics of Losmapimod in healthy males, NCT00599612

    Inglés

    Alcohol test, drug screen

    1 formularios  
    Administrative data
    Descripción

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject identifier
    Descripción

    Subject identifier

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2348585
    Visit Description
    Descripción

    Visit Description

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C0678257
    ALCOHOL INTAKE
    Descripción

    ALCOHOL INTAKE

    Alias
    UMLS CUI-1
    C0001948
    Does the subject consume alcohol?
    Descripción

    Only for screening.

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0001948
    If subject consume alcohol, record the average number of units of alcohol consumed per week
    Descripción

    ALCOHOL CONVERTER: 1 unit of alcohol in UK = 1 measure of spirits, 1/2 pint beer, 1 small glass of wine (125ml) See facing page for conversion guidelines.

    Tipo de datos

    float

    Unidades de medida
    • units per week
    Alias
    UMLS CUI [1,1]
    C0001948
    UMLS CUI [1,2]
    C0560579
    units per week
    ALCOHOL BREATH TEST
    Descripción

    ALCOHOL BREATH TEST

    Alias
    UMLS CUI-1
    C0202306
    Date sample taken
    Descripción

    day month year

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C1302413
    Results of sample
    Descripción

    If positive, exclude subject from the study.

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0456984
    DRUG SCREEN
    Descripción

    DRUG SCREEN

    Alias
    UMLS CUI-1
    C0373483
    Date of sample taken
    Descripción

    day month year

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C1302413
    Time of sample taken
    Descripción

    00:00-23:59

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0200345
    Drugs
    Descripción

    Tick appropriate box(es). Note for each drug the result.

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0033978
    Drug result
    Descripción

    Note for each drug the result. If any of the drugs are positive, exclude subject from the study.

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0033978
    UMLS CUI [1,2]
    C1274040
    Volver a la parte superior de la página

    Similar models

    Alcohol test, drug screen

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Subject identifier
    Item
    Subject identifier
    text
    C2348585 (UMLS CUI [1])
    Item
    Visit Description
    integer
    C0545082 (UMLS CUI [1,1])
    C0678257 (UMLS CUI [1,2])
    Visit Description
    Code List
    Visit Description
    CL Item
    Screening (1)
    CL Item
    Study visit (2)
    Item Group
    ALCOHOL INTAKE
    C0001948 (UMLS CUI-1)
    Item
    Does the subject consume alcohol?
    text
    C0001948 (UMLS CUI [1])
    Alcohol consumption
    Code List
    Does the subject consume alcohol?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Alcohol consumption, units per week
    Item
    If subject consume alcohol, record the average number of units of alcohol consumed per week
    float
    C0001948 (UMLS CUI [1,1])
    C0560579 (UMLS CUI [1,2])
    Item Group
    ALCOHOL BREATH TEST
    C0202306 (UMLS CUI-1)
    Date sample taken
    Item
    Date sample taken
    date
    C1302413 (UMLS CUI [1])
    Item
    Results of sample
    text
    C0456984 (UMLS CUI [1])
    Results of sample
    Code List
    Results of sample
    CL Item
    Positive (P)
    CL Item
    Negative (N)
    Item Group
    DRUG SCREEN
    C0373483 (UMLS CUI-1)
    Date of sample taken
    Item
    Date of sample taken
    date
    C1302413 (UMLS CUI [1])
    Time of sample taken
    Item
    Time of sample taken
    time
    C0040223 (UMLS CUI [1,1])
    C0200345 (UMLS CUI [1,2])
    Item
    Drugs
    text
    C0033978 (UMLS CUI [1])
    Drugs
    Code List
    Drugs
    CL Item
    Cocaine (1)
    CL Item
    Amphetamines (2)
    CL Item
    Benzodiazepines (3)
    CL Item
    Cannabinoids (4)
    CL Item
    Opiates (5)
    CL Item
    Barbiturates (6)
    CL Item
    Methadone (7)
    CL Item
    Cotinine (8)
    Item
    Drug result
    text
    C0033978 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    Drug result
    Code List
    Drug result
    CL Item
    Positive (P)
    CL Item
    Negative (N)
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