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ID

22574

Beskrivning

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

Länk

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

Nyckelord

Versioner (2)
  1. 2017-06-08 2017-06-08 -
  2. 2017-06-12 2017-06-12 -
Uppladdad den

8 juni 2017

DOI

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Licens

Creative Commons BY-NC 3.0
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    Intermittent Ropinirole in Restless Legs Syndrome (RLS) NCT00225862 - Part 21: Visit 3 (Week 5) RLS Episode 9

    Engelsk

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

    1 Formulär  
    General Information
    Beskrivning

    General Information

    Subject Identifier
    Beskrivning

    Subject Identifier

    Datatyp

    text

    PRN Subject Diary
    Beskrivning

    PRN Subject Diary

    1. Enter the date and time your RLs symptoms started.
    Beskrivning

    Date

    Datatyp

    datetime

    2. How severe were your RLS symptoms at the time you took the dose of study medication?
    Beskrivning

    Severity of RLS episode

    Datatyp

    text

    3. Did your RLS symptoms disrupt your routine evening activity?
    Beskrivning

    Did your RLS symptoms disrupt your routine evening activity?

    Datatyp

    boolean

    4. How severe were your RLS symptoms 2 hours after taking the study medication?
    Beskrivning

    Severity two hours after medication

    Datatyp

    text

    5. Overall, how would you describe the change in your RLS symptoms after dosing last night?
    Beskrivning

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

    Datatyp

    text

    6. Overall, did your RLS symptoms affect your sleep last night?
    Beskrivning

    Sleep affected by RLS symptoms?

    Datatyp

    boolean

    If yes, did your RLS symptoms prevent you from falling asleep or staying asleep last night?
    Beskrivning

    Specification of RLS symptoms affecting sleep

    Datatyp

    boolean

    Study Medication
    Beskrivning

    Study Medication

    Date study medication taken
    Beskrivning

    Date study medication taken

    Datatyp

    date

    Time study medication taken
    Beskrivning

    Time study medication taken

    Datatyp

    time

    Tillbaka till toppen

    Similar models

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

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    General Information
    Subject Identifier
    Item
    Subject Identifier
    text
    Item Group
    PRN Subject Diary
    Date
    Item
    1. Enter the date and time your RLs symptoms started.
    datetime
    Item
    2. How severe were your RLS symptoms at the time you took the dose of study medication?
    text
    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
    Item
    4. How severe were your RLS symptoms 2 hours after taking the study medication?
    text
    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
    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
    Specification of RLS symptoms affecting sleep
    Item
    If yes, did your RLS symptoms prevent you from falling asleep or staying asleep last night?
    boolean
    Item Group
    Study Medication
    Date study medication taken
    Item
    Date study medication taken
    date
    Time study medication taken
    Item
    Time study medication taken
    time
    Tillbaka till toppen 

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