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ID

44323

Description

Study ID: 101468/218 Clinical Study ID: SKF-101468/218 Study Title:A Single-Blind, Randomised, Placebo-Controlled, Parallel-Group, Multicentre, Phase IIa Study to Determine the Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Restless Legs Syndrome

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Versions (2)
  1. 4/27/20 4/27/20 -
  2. 9/20/21 9/20/21 -
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GlaxoSmithKline

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September 20, 2021

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Creative Commons BY-NC 4.0
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    Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/218

    English

    Dose Level 1, Day1, Pre-dose - Prior Medication; Pregnancy Test; Alcohol Breath Test; Drug Screening (Urine); Vital Signs

    1 forms  
    Administrative
    Description

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Patient Number
    Description

    Patient Number

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Centre Number
    Description

    Centre Number

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0600091
    UMLS CUI [1,2]
    C0019994
    Prior Medication
    Description

    Prior Medication

    Alias
    UMLS CUI-1
    C2826257
    Has the subject taken any medication within 1 week PRIOR to the first dose of study medication?
    Description

    If ’YES’, please record the medications below. NB: Any medications Metabolised by CYPIA2 must be kept constant throughout the study.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2826257
    UMLS CUI [2,1]
    C0013230
    UMLS CUI [2,2]
    C3174092
    UMLS CUI [2,3]
    C0205435
    Prior Medication
    Description

    Prior Medication

    Alias
    UMLS CUI-1
    C2826257
    Prior Medication - Drug Name
    Description

    Trade Name Preferred

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826257
    UMLS CUI [2]
    C2360065
    Prior Medication - Single Dose/ Unit
    Description

    e.g.500mg

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826257
    UMLS CUI [2]
    C1960417
    Prior Medication - Frequency of this Dose
    Description

    e.g.BID,PRN

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826257
    UMLS CUI [2]
    C3476109
    Prior Medication - Route
    Description

    Prior Medication - Route

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826257
    UMLS CUI [2]
    C0013153
    Prior Medication - Indication
    Description

    Prior Medication - Indication

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2826257
    UMLS CUI [1,2]
    C3146298
    Prior Medication - Duration of Therapy
    Description

    eg.6 years

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2826257
    UMLS CUI [1,2]
    C0444921
    Prior Medication - End Date
    Description

    Prior Medication - End Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2826257
    UMLS CUI [1,2]
    C0806020
    Prior Medication - Continuing at end of study?
    Description

    Prior Medication - Continuing at end of study?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2826257
    UMLS CUI [1,2]
    C1553904
    UMLS CUI [1,3]
    C2983670
    Pregnancy Test
    Description

    Pregnancy Test

    Alias
    UMLS CUI-1
    C0032976
    Was a pregnancy test carried out?
    Description

    Was a pregnancy test carried out?

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032976
    If no pregnancy test was carried out, please specify reason
    Description

    If no pregnancy test was carried out, please specify reason

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0032976
    UMLS CUI [1,2]
    C2826287
    Date of pregnancy test
    Description

    Date of pregnancy test

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0032976
    UMLS CUI [1,2]
    C0011008
    Pregnancy test result
    Description

    Pregnancy test result

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0427777
    Alcohol Breath Test
    Description

    Alcohol Breath Test

    Alias
    UMLS CUI-1
    C0202306
    Was an alcohol breath test carried out?
    Description

    Was an alcohol breath test carried out?

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0202306
    If no alcohol breath test was carried out, specify reason
    Description

    If no alcohol breath test was carried out, specify reason

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0202306
    UMLS CUI [1,2]
    C2826287
    If alcohol breath test was carried out, indicate date of alcohol breath test
    Description

    If alcohol breath test was carried out, indicate date of alcohol breath test

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0202306
    UMLS CUI [1,2]
    C001100
    Alcohol breath test result
    Description

    Alcohol breath test result

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0202306
    UMLS CUI [1,2]
    C0587081
    Drug Screening (Urine)
    Description

    Drug Screening (Urine)

    Alias
    UMLS CUI-1
    C0202274
    Drug Screening (Urine) - Exact date end time of sampling
    Description

    Drug Screening (Urine) - Exact date end time of sampling

    Data type

    datetime

    Alias
    UMLS CUI [1]
    C0202274
    UMLS CUI [2,1]
    C0870078
    UMLS CUI [2,2]
    C0011008
    UMLS CUI [2,3]
    C0040223
    Were there any contra-indicated drugs detected?
    Description

    If YES, please record all the relevant contra-indicated drugs below.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1511790
    UMLS CUI [1,2]
    C4036061
    UMLS CUI [1,3]
    C1301624
    Drug Screening (Urine) - Type of drug
    Description

    Drug Screening (Urine) - Type of drug

    Data type

    text

    Alias
    UMLS CUI [1]
    C0202274
    UMLS CUI [2]
    C0457591
    Drug Screening (Urine) - Comment
    Description

    Drug Screening (Urine) - Comment

    Data type

    text

    Alias
    UMLS CUI [1]
    C0202274
    UMLS CUI [2]
    C0947611
    Vital Signs
    Description

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766
    Vital Signs - Date and Time
    Description

    Vital Signs - Date and Time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C0040223
    Vital Signs - Semi-supine BP Systolic
    Description

    Vital Signs - Semi-supine BP Systolic

    Data type

    integer

    Measurement units
    • mm[Hg]
    Alias
    UMLS CUI [1]
    C0518766
    UMLS CUI [2,1]
    C0871470
    UMLS CUI [2,2]
    C0522019
    mm[Hg]
    Vital Signs - Semi-supine BP Diastolic
    Description

    Vital Signs - Semi-supine BP Diastolic

    Data type

    integer

    Measurement units
    • mm[Hg]
    Alias
    UMLS CUI [1]
    C0518766
    UMLS CUI [2,1]
    C0428883
    UMLS CUI [2,2]
    C0522019
    mm[Hg]
    Vital Signs - Semi-supine Hear Rate
    Description

    Vital Signs - Semi-supine Hear Rate

    Data type

    integer

    Measurement units
    • beats/min
    Alias
    UMLS CUI [1]
    C0518766
    UMLS CUI [2,1]
    C0018810
    UMLS CUI [2,2]
    C0522019
    beats/min
    Vital Signs - Time
    Description

    Vital Signs - Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0040223
    Vital Signs - Erect BP Systolic
    Description

    Vital Signs - Erect BP Systolic

    Data type

    integer

    Measurement units
    • mm[Hg]
    Alias
    UMLS CUI [1]
    C0518766
    UMLS CUI [2,1]
    C0871470
    UMLS CUI [2,2]
    C0522014
    mm[Hg]
    Vital Signs - Erect BP Diastolic
    Description

    Vital Signs - Erect BP Diastolic

    Data type

    integer

    Measurement units
    • mm[Hg]
    Alias
    UMLS CUI [1]
    C0518766
    UMLS CUI [2,1]
    C0428883
    UMLS CUI [2,2]
    C0522014
    mm[Hg]
    Vital Signs - Erect Heart Rate
    Description

    Vital Signs - Erect Heart Rate

    Data type

    integer

    Measurement units
    • beats/min
    Alias
    UMLS CUI [1]
    C0518766
    UMLS CUI [2,1]
    C0018810
    UMLS CUI [2,2]
    C0522014
    beats/min
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    Similar models

    Dose Level 1, Day1, Pre-dose - Prior Medication; Pregnancy Test; Alcohol Breath Test; Drug Screening (Urine); Vital Signs

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative
    C1320722 (UMLS CUI-1)
    Patient Number
    Item
    Patient Number
    text
    C2348585 (UMLS CUI [1])
    Centre Number
    Item
    Centre Number
    text
    C0600091 (UMLS CUI [1,1])
    C0019994 (UMLS CUI [1,2])
    Item Group
    Prior Medication
    C2826257 (UMLS CUI-1)
    Has the subject taken any medication within 1 week PRIOR to the first dose of study medication?
    Item
    Has the subject taken any medication within 1 week PRIOR to the first dose of study medication?
    boolean
    C2826257 (UMLS CUI [1])
    C0013230 (UMLS CUI [2,1])
    C3174092 (UMLS CUI [2,2])
    C0205435 (UMLS CUI [2,3])
    Item Group
    Prior Medication
    C2826257 (UMLS CUI-1)
    Prior Medication - Drug Name
    Item
    Prior Medication - Drug Name
    text
    C2826257 (UMLS CUI [1])
    C2360065 (UMLS CUI [2])
    Prior Medication - Single Dose/ Unit
    Item
    Prior Medication - Single Dose/ Unit
    text
    C2826257 (UMLS CUI [1])
    C1960417 (UMLS CUI [2])
    Prior Medication - Frequency of this Dose
    Item
    Prior Medication - Frequency of this Dose
    text
    C2826257 (UMLS CUI [1])
    C3476109 (UMLS CUI [2])
    Item
    Prior Medication - Route
    text
    C2826257 (UMLS CUI [1])
    C0013153 (UMLS CUI [2])
    Prior Medication - Route
    Code List
    Prior Medication - Route
    CL Item
    intra-articular (IA)
    CL Item
    intra-arterial (IAR)
    CL Item
    intra-dermal (ID)
    CL Item
    inhalation (IH)
    CL Item
    intra-muscular (IM)
    CL Item
    intra-thecal (IT)
    CL Item
    intra-venous (IV)
    CL Item
    nasal (NA)
    CL Item
    oral (PO)
    CL Item
    rectal (PR)
    CL Item
    subcutaneous (SC)
    CL Item
    sublingual (SL)
    CL Item
    transdermal (TD)
    CL Item
    topical (TO)
    CL Item
    vaginal (VA)
    Prior Medication - Indication
    Item
    Prior Medication - Indication
    text
    C2826257 (UMLS CUI [1,1])
    C3146298 (UMLS CUI [1,2])
    Prior Medication - Duration of Therapy
    Item
    Prior Medication - Duration of Therapy
    text
    C2826257 (UMLS CUI [1,1])
    C0444921 (UMLS CUI [1,2])
    Prior Medication - End Date
    Item
    Prior Medication - End Date
    date
    C2826257 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Prior Medication - Continuing at end of study?
    Item
    Prior Medication - Continuing at end of study?
    boolean
    C2826257 (UMLS CUI [1,1])
    C1553904 (UMLS CUI [1,2])
    C2983670 (UMLS CUI [1,3])
    Item Group
    Pregnancy Test
    C0032976 (UMLS CUI-1)
    Was a pregnancy test carried out?
    Item
    Was a pregnancy test carried out?
    boolean
    C0032976 (UMLS CUI [1])
    If no pregnancy test was carried out, please specify reason
    Item
    If no pregnancy test was carried out, please specify reason
    text
    C0032976 (UMLS CUI [1,1])
    C2826287 (UMLS CUI [1,2])
    Date of pregnancy test
    Item
    Date of pregnancy test
    date
    C0032976 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Pregnancy test result
    integer
    C0427777 (UMLS CUI [1])
    Pregnancy test result
    Code List
    Pregnancy test result
    CL Item
    Positive (1)
    CL Item
    Negative (2)
    Item Group
    Alcohol Breath Test
    C0202306 (UMLS CUI-1)
    Was an alcohol breath test carried out?
    Item
    Was an alcohol breath test carried out?
    boolean
    C0202306 (UMLS CUI [1])
    If no alcohol breath test was carried out, specify reason
    Item
    If no alcohol breath test was carried out, specify reason
    text
    C0202306 (UMLS CUI [1,1])
    C2826287 (UMLS CUI [1,2])
    If alcohol breath test was carried out, indicate date of alcohol breath test
    Item
    If alcohol breath test was carried out, indicate date of alcohol breath test
    date
    C0202306 (UMLS CUI [1,1])
    C001100 (UMLS CUI [1,2])
    Item
    Alcohol breath test result
    integer
    C0202306 (UMLS CUI [1,1])
    C0587081 (UMLS CUI [1,2])
    Alcohol breath test result
    Code List
    Alcohol breath test result
    CL Item
    Positive  (1)
    CL Item
    Negative (2)
    Item Group
    Drug Screening (Urine)
    C0202274 (UMLS CUI-1)
    Drug Screening (Urine) - Exact date end time of sampling
    Item
    Drug Screening (Urine) - Exact date end time of sampling
    datetime
    C0202274 (UMLS CUI [1])
    C0870078 (UMLS CUI [2,1])
    C0011008 (UMLS CUI [2,2])
    C0040223 (UMLS CUI [2,3])
    Were there any contra-indicated drugs detected?
    Item
    Were there any contra-indicated drugs detected?
    boolean
    C1511790 (UMLS CUI [1,1])
    C4036061 (UMLS CUI [1,2])
    C1301624 (UMLS CUI [1,3])
    Drug Screening (Urine) - Type of drug
    Item
    Drug Screening (Urine) - Type of drug
    text
    C0202274 (UMLS CUI [1])
    C0457591 (UMLS CUI [2])
    Drug Screening (Urine) - Comment
    Item
    Drug Screening (Urine) - Comment
    text
    C0202274 (UMLS CUI [1])
    C0947611 (UMLS CUI [2])
    Item Group
    Vital Signs
    C0518766 (UMLS CUI-1)
    Vital Signs - Date and Time
    Item
    Vital Signs - Date and Time
    datetime
    C0518766 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Vital Signs - Semi-supine BP Systolic
    Item
    Vital Signs - Semi-supine BP Systolic
    integer
    C0518766 (UMLS CUI [1])
    C0871470 (UMLS CUI [2,1])
    C0522019 (UMLS CUI [2,2])
    Vital Signs - Semi-supine BP Diastolic
    Item
    Vital Signs - Semi-supine BP Diastolic
    integer
    C0518766 (UMLS CUI [1])
    C0428883 (UMLS CUI [2,1])
    C0522019 (UMLS CUI [2,2])
    Vital Signs - Semi-supine Hear Rate
    Item
    Vital Signs - Semi-supine Hear Rate
    integer
    C0518766 (UMLS CUI [1])
    C0018810 (UMLS CUI [2,1])
    C0522019 (UMLS CUI [2,2])
    Vital Signs - Time
    Item
    Vital Signs - Time
    time
    C0518766 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Vital Signs - Erect BP Systolic
    Item
    Vital Signs - Erect BP Systolic
    integer
    C0518766 (UMLS CUI [1])
    C0871470 (UMLS CUI [2,1])
    C0522014 (UMLS CUI [2,2])
    Vital Signs - Erect BP Diastolic
    Item
    Vital Signs - Erect BP Diastolic
    integer
    C0518766 (UMLS CUI [1])
    C0428883 (UMLS CUI [2,1])
    C0522014 (UMLS CUI [2,2])
    Vital Signs - Erect Heart Rate
    Item
    Vital Signs - Erect Heart Rate
    integer
    C0518766 (UMLS CUI [1])
    C0018810 (UMLS CUI [2,1])
    C0522014 (UMLS CUI [2,2])
    Back to the top of the page 

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