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ID

22822

Description

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 26: Visit 4 (Week 7) RLS Episode 3 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

Keywords

Versions (2)
  1. 6/8/17 6/8/17 -
  2. 6/12/17 6/12/17 -
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June 12, 2017

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Creative Commons BY-NC 3.0
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    Intermittent Ropinirole in Restless Legs Syndrome (RLS) NCT00225862 - Part 26: Visit 4 (Week 7) RLS Episode 3

    English

    Intermittent Ropinirole in Restless Legs Syndrome (RLS) NCT00225862 - Part 26: Visit 4 (Week 7) RLS Episode 3

    1 forms  
    General Information
    Description

    General Information

    Alias
    UMLS CUI-1
    C1508263 (General information section)
    LOINC
    MTHU015719
    UMLS CUI-2
    C1955348 (Patient Information)
    UMLS CUI-3
    C0035258 (Restless Legs Syndrome)
    SNOMED
    32914008
    Subject Identifier
    Description

    Subject Identifier

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    PRN Subject Diary
    Description

    PRN Subject Diary

    Alias
    UMLS CUI-1
    C3890583 (Subject Diary)
    UMLS CUI-2
    C0035258 (Restless Legs Syndrome)
    SNOMED
    32914008
    1. Enter the date and time your RLs symptoms started.
    Description

    Date

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,2]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    UMLS CUI [1,3]
    C0035258 (Restless Legs Syndrome)
    SNOMED
    32914008
    UMLS CUI [1,4]
    C1457887 (Symptoms)
    LOINC
    MTHU021540
    2. How severe were your RLS symptoms at the time you took the dose of study medication?
    Description

    Severity of RLS episode

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0439793 (Severities)
    SNOMED
    272141005
    UMLS CUI [1,2]
    C0035258 (Restless Legs Syndrome)
    SNOMED
    32914008
    UMLS CUI [1,3]
    C1457887 (Symptoms)
    LOINC
    MTHU021540
    UMLS CUI [2]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    3. Did your RLS symptoms disrupt your routine evening activity?
    Description

    Did your RLS symptoms disrupt your routine evening activity?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0332453 (Disruption)
    SNOMED
    76555007
    LOINC
    LA19648-7
    UMLS CUI [1,2]
    C0001288 (Activities of Daily Living (activity))
    SNOMED
    129025006
    LOINC
    LP57620-4
    UMLS CUI [1,3]
    C0035258 (Restless Legs Syndrome)
    SNOMED
    32914008
    4. How severe were your RLS symptoms 2 hours after taking the study medication?
    Description

    Severity two hours after medication

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0439793 (Severities)
    SNOMED
    272141005
    UMLS CUI [1,2]
    C1457887 (Symptoms)
    LOINC
    MTHU021540
    UMLS CUI [1,3]
    C0035258 (Restless Legs Syndrome)
    SNOMED
    32914008
    UMLS CUI [2]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    5. Overall, how would you describe the change in your RLS symptoms after dosing last night?
    Description

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

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1515926 (Alteration)
    UMLS CUI [1,2]
    C1457887 (Symptoms)
    LOINC
    MTHU021540
    UMLS CUI [1,3]
    C0035258 (Restless Legs Syndrome)
    SNOMED
    32914008
    UMLS CUI [2]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    6. Overall, did your RLS symptoms affect your sleep last night?
    Description

    Sleep affected by RLS symptoms?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0037313 (Sleep)
    SNOMED
    258158006
    LOINC
    LA18125-7
    UMLS CUI [1,2]
    C0392760 (Affecting)
    SNOMED
    247591002
    UMLS CUI [1,3]
    C0035258 (Restless Legs Syndrome)
    SNOMED
    32914008
    If yes, did your RLS symptoms prevent you from falling asleep or staying asleep last night?
    Description

    Specification of RLS symptoms affecting sleep

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0393760 (Initial insomnia)
    SNOMED
    59050008
    LOINC
    LP121706-8
    UMLS CUI [1,2]
    C0037317 (Sleep disturbances)
    SNOMED
    53888004
    UMLS CUI [1,3]
    C0035258 (Restless Legs Syndrome)
    SNOMED
    32914008
    Study Medication
    Description

    Study Medication

    Alias
    UMLS CUI-1
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    UMLS CUI-2
    C0304229 (Experimental drug)
    UMLS CUI-3
    C0008976 (Clinical Trials)
    SNOMED
    110465008
    LOINC
    LP231796-6
    UMLS CUI-4
    C0035258 (Restless Legs Syndrome)
    SNOMED
    32914008
    Date study medication taken
    Description

    Date study medication taken

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,2]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    Time study medication taken
    Description

    Time study medication taken

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    UMLS CUI [1,2]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
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    Similar models

    Intermittent Ropinirole in Restless Legs Syndrome (RLS) NCT00225862 - Part 26: Visit 4 (Week 7) RLS Episode 3

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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])
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