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22818

Beschreibung

Study ID: 100310 Clinical Study ID: RRL100310 Study Title: A 12-week, double-blind, placebo-controlled, parallel group study to assess the efficacy and safety of intermittent dosing of ropinirole in patients with Restless Legs Syndrome (RLS) Part 21: Visit 3 (Week 5) RLS Episode 9 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00225862 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome More details on: https://clinicaltrials.gov/ct2/show/NCT00225862

Link

https://clinicaltrials.gov/ct2/show/NCT00225862

Stichworte

Versionen (2)
  1. 08.06.17 08.06.17 -
  2. 12.06.17 12.06.17 -
Hochgeladen am

12. Juni 2017

DOI

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    Intermittent Ropinirole in Restless Legs Syndrome (RLS) NCT00225862 - Part 21: Visit 3 (Week 5) RLS Episode 9

    Englisch

    Intermittent Ropinirole in Restless Legs Syndrome (RLS) NCT00225862 - Part 21: Visit 3 (Week 5) RLS Episode 9

    1 Formulare  
    General Information
    Beschreibung

    General Information

    Alias
    UMLS CUI-1
    C1508263
    UMLS CUI-2
    C1955348
    UMLS CUI-3
    C0035258
    Subject Identifier
    Beschreibung

    Subject Identifier

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2348585
    PRN Subject Diary
    Beschreibung

    PRN Subject Diary

    Alias
    UMLS CUI-1
    C3890583
    UMLS CUI-2
    C0035258
    1. Enter the date and time your RLs symptoms started.
    Beschreibung

    Date

    Datentyp

    datetime

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0040223
    UMLS CUI [1,3]
    C0035258
    UMLS CUI [1,4]
    C1457887
    2. How severe were your RLS symptoms at the time you took the dose of study medication?
    Beschreibung

    Severity of RLS episode

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0439793
    UMLS CUI [1,2]
    C0035258
    UMLS CUI [1,3]
    C1457887
    UMLS CUI [2]
    C0013227
    3. Did your RLS symptoms disrupt your routine evening activity?
    Beschreibung

    Did your RLS symptoms disrupt your routine evening activity?

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0332453
    UMLS CUI [1,2]
    C0001288
    UMLS CUI [1,3]
    C0035258
    4. How severe were your RLS symptoms 2 hours after taking the study medication?
    Beschreibung

    Severity two hours after medication

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0439793
    UMLS CUI [1,2]
    C1457887
    UMLS CUI [1,3]
    C0035258
    UMLS CUI [2]
    C0013227
    5. Overall, how would you describe the change in your RLS symptoms after dosing last night?
    Beschreibung

    Read the following and complete the questions when you wake up next morning.

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1515926
    UMLS CUI [1,2]
    C1457887
    UMLS CUI [1,3]
    C0035258
    UMLS CUI [2]
    C0013227
    6. Overall, did your RLS symptoms affect your sleep last night?
    Beschreibung

    Sleep affected by RLS symptoms?

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0037313
    UMLS CUI [1,2]
    C0392760
    UMLS CUI [1,3]
    C0035258
    If yes, did your RLS symptoms prevent you from falling asleep or staying asleep last night?
    Beschreibung

    Specification of RLS symptoms affecting sleep

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0393760
    UMLS CUI [1,2]
    C0037317
    UMLS CUI [1,3]
    C0035258
    Study Medication
    Beschreibung

    Study Medication

    Alias
    UMLS CUI-1
    C0013227
    UMLS CUI-2
    C0304229
    UMLS CUI-3
    C0008976
    UMLS CUI-4
    C0035258
    Date study medication taken
    Beschreibung

    Date study medication taken

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0013227
    Time study medication taken
    Beschreibung

    Time study medication taken

    Datentyp

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0013227
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Intermittent Ropinirole in Restless Legs Syndrome (RLS) NCT00225862 - Part 21: Visit 3 (Week 5) RLS Episode 9

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    General Information
    C1508263 (UMLS CUI-1)
    C1955348 (UMLS CUI-2)
    C0035258 (UMLS CUI-3)
    Subject Identifier
    Item
    Subject Identifier
    text
    C2348585 (UMLS CUI [1])
    Item Group
    PRN Subject Diary
    C3890583 (UMLS CUI-1)
    C0035258 (UMLS CUI-2)
    Date
    Item
    1. Enter the date and time your RLs symptoms started.
    datetime
    C0011008 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    C0035258 (UMLS CUI [1,3])
    C1457887 (UMLS CUI [1,4])
    Item
    2. How severe were your RLS symptoms at the time you took the dose of study medication?
    text
    C0439793 (UMLS CUI [1,1])
    C0035258 (UMLS CUI [1,2])
    C1457887 (UMLS CUI [1,3])
    C0013227 (UMLS CUI [2])
    Severity of RLS episode
    Code List
    2. How severe were your RLS symptoms at the time you took the dose of study medication?
    CL Item
    mild (1)
    CL Item
    moderate (2)
    CL Item
    severe (3)
    CL Item
    very severe (4)
    Did your RLS symptoms disrupt your routine evening activity?
    Item
    3. Did your RLS symptoms disrupt your routine evening activity?
    boolean
    C0332453 (UMLS CUI [1,1])
    C0001288 (UMLS CUI [1,2])
    C0035258 (UMLS CUI [1,3])
    Item
    4. How severe were your RLS symptoms 2 hours after taking the study medication?
    text
    C0439793 (UMLS CUI [1,1])
    C1457887 (UMLS CUI [1,2])
    C0035258 (UMLS CUI [1,3])
    C0013227 (UMLS CUI [2])
    Severity two hours after medication
    Code List
    4. How severe were your RLS symptoms 2 hours after taking the study medication?
    CL Item
    I was asleep at 2 hours after taking the last dose  (1)
    CL Item
    None (2)
    CL Item
    Mild (3)
    CL Item
    Moderate (4)
    CL Item
    Severe (5)
    CL Item
    Very Severe (6)
    Item
    5. Overall, how would you describe the change in your RLS symptoms after dosing last night?
    text
    C1515926 (UMLS CUI [1,1])
    C1457887 (UMLS CUI [1,2])
    C0035258 (UMLS CUI [1,3])
    C0013227 (UMLS CUI [2])
    Change in RLS symptoms after dosing the night before
    Code List
    5. Overall, how would you describe the change in your RLS symptoms after dosing last night?
    CL Item
    Very much improved (Complete symptom relief) (1)
    CL Item
    Much improved (Good symptom relief) (2)
    CL Item
    Minimally improved (Some symptom relief) (3)
    CL Item
    No change (4)
    CL Item
    Minimally worse (Symptoms minimally worse) (5)
    CL Item
    Much worse (Symptoms much worse) (6)
    CL Item
    Very much worse (Symptoms very much worse) (7)
    Sleep affected by RLS symptoms?
    Item
    6. Overall, did your RLS symptoms affect your sleep last night?
    boolean
    C0037313 (UMLS CUI [1,1])
    C0392760 (UMLS CUI [1,2])
    C0035258 (UMLS CUI [1,3])
    Specification of RLS symptoms affecting sleep
    Item
    If yes, did your RLS symptoms prevent you from falling asleep or staying asleep last night?
    boolean
    C0393760 (UMLS CUI [1,1])
    C0037317 (UMLS CUI [1,2])
    C0035258 (UMLS CUI [1,3])
    Item Group
    Study Medication
    C0013227 (UMLS CUI-1)
    C0304229 (UMLS CUI-2)
    C0008976 (UMLS CUI-3)
    C0035258 (UMLS CUI-4)
    Date study medication taken
    Item
    Date study medication taken
    date
    C0011008 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Time study medication taken
    Item
    Time study medication taken
    time
    C0040223 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Zum Seitenanfang zurückkehren 

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