ID

29007

Description

Study ID: 101468/249 Clinical Study ID: 101468/249 Study Title: A 12-Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00363857 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: N/A 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; Restless Legs Syndrome (RLS)

Keywords

Versions (1)
  1. 2/20/18 2/20/18 -
Copyright Holder

GlaxoSmithKline (GSK)

Uploaded on

February 20, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Clinical Study, Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS), Study ID: 101468/249, NCT00363857

English

RLS history and diagnostic criteria

1 forms  
Administration
Description

Administration

Alias
UMLS CUI-1
C1320722
Patient number
Description

Patient number

Data type

integer

Alias
UMLS CUI [1]
C1830427
Visit date
Description

Visit date

Data type

date

Alias
UMLS CUI [1]
C1320303
Center Number
Description

Center Number

Data type

integer

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
RLS Screen History
Description

RLS Screen History

Alias
UMLS CUI-1
C0035258
UMLS CUI-2
C0262926
How old was the patient at the onset of RLS?
Description

Years (in whole years)

Data type

integer

Alias
UMLS CUI [1]
C0150907
Did the patient start any new medication near the time of their first onset of RLS symptoms that may have caused RLS?
Description

Medication related to onset of symptoms

Data type

text

Alias
UMLS CUI [1,1]
C0277793
UMLS CUI [1,2]
C0013227
If ’Yes’ please specify medication(s)
Description

If you answered the previous question with 'yes', please specify:

Data type

text

Alias
UMLS CUI [1]
C0013227
If female, did RLS symptoms develop during pregnancy?
Description

RLS related to pregnancy

Data type

text

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0032961
Has the patient ever had PLMS (Periodic Limb Movements during Sleep)?
Description

Periodic Limb Movements

Data type

text

Alias
UMLS CUI [1,1]
C0596840
UMLS CUI [1,2]
C0037313
UMLS CUI [2]
C0035258
How old was the patient at the onset of PLMS? Years (in whole years)
Description

If you answered the previous question with 'yes', please specify:

Data type

integer

Alias
UMLS CUI [1,1]
C0206132
UMLS CUI [1,2]
C0596840
UMLS CUI [2,1]
C0037313
UMLS CUI [2,2]
C0035258
Does the patient drink alcohol?
Description

Alcohol

Data type

text

Alias
UMLS CUI [1]
C0001948
Units/week
Description

If you answered the previous question with 'yes', please specify: One unit is equivalent to: US - 1.5oz hard liquor, 1 beer, 4oz wine

Data type

integer

Alias
UMLS CUI [1]
C0001948
Does the patient drink caffeine (coffee, tea, caffeinated drinks)?
Description

Caffeine

Data type

text

Alias
UMLS CUI [1]
C0948365
Cups/day
Description

If you answered the previous question with 'yes', please specify:

Data type

integer

Alias
UMLS CUI [1]
C0948365
Does the patient have any sleep disorder as defined by DSM IV excluding RLS?
Description

If ’Yes’ please record on the Significant Medical/Surgical History and Physical Examination page.

Data type

text

Alias
UMLS CUI [1]
C0851578
Has any first degree relative (mother/father, brother/sister, son/daughter) of the patient ever been diagnosed with or had symptoms of RLS?
Description

Family history of RLS

Data type

text

Alias
UMLS CUI [1,1]
C0241889
UMLS CUI [1,2]
C0035258
Has any first degree relative (mother/father, brother/sister, son/daughter) of the patient ever ... been diagnosed with or had symptoms of PLMS?
Description

Family history of PLMS

Data type

text

Alias
UMLS CUI [1,1]
C0241889
UMLS CUI [1,2]
C0596840
UMLS CUI [1,3]
C0037313
Are the patient’s current symptoms mainly present..
Description

Presence of symptoms

Data type

integer

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0150312
RLS Diagnostic Criteria
Description

RLS Diagnostic Criteria

Alias
UMLS CUI-1
C0035258
UMLS CUI-2
C0679228
A desire to move the limbs usually associated with paresthesias or dysesthesias
Description

limb movement associated with paresthesias or dysesthesias

Data type

boolean

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C0596840
UMLS CUI [1,3]
C0030554
UMLS CUI [1,4]
C0392699
motor restlessness (during wakefulness does the patient move the limbs in attempt to relieve the discomfort)
Description

motor restlessness

Data type

boolean

Alias
UMLS CUI [1]
C0700075
symptoms worse or exclusively present at rest with at least partial and temporal relief by activity
Description

Symptoms at rest

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0035253
symptoms worse in the evening or night
Description

Symptoms in the evening or night

Data type

boolean

Alias
UMLS CUI [1,1]
C3176727
UMLS CUI [1,2]
C0035258
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Similar models

RLS history and diagnostic criteria

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administration
C1320722 (UMLS CUI-1)
Patient number
Item
Patient number
integer
C1830427 (UMLS CUI [1])
Visit date
Item
Visit date
date
C1320303 (UMLS CUI [1])
Center Number
Item
Center Number
integer
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Item Group
RLS Screen History
C0035258 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
Age of Patient at first symptoms
Item
How old was the patient at the onset of RLS?
integer
C0150907 (UMLS CUI [1])
Item
Did the patient start any new medication near the time of their first onset of RLS symptoms that may have caused RLS?
text
C0277793 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Medication related to onset of symptoms
Code List
Did the patient start any new medication near the time of their first onset of RLS symptoms that may have caused RLS?
CL Item
No (N)
CL Item
Yes (Y)
Medication
Item
If ’Yes’ please specify medication(s)
text
C0013227 (UMLS CUI [1])
Item
If female, did RLS symptoms develop during pregnancy?
text
C0035258 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0032961 (UMLS CUI [1,3])
RLS related to pregnancy
Code List
If female, did RLS symptoms develop during pregnancy?
CL Item
No (N)
CL Item
Yes (Y)
CL Item
Not applicable (X)
Item
Has the patient ever had PLMS (Periodic Limb Movements during Sleep)?
text
C0596840 (UMLS CUI [1,1])
C0037313 (UMLS CUI [1,2])
C0035258 (UMLS CUI [2])
Periodic Limb Movements
Code List
Has the patient ever had PLMS (Periodic Limb Movements during Sleep)?
CL Item
No (N)
CL Item
Yes (Y)
Onset of PLMS
Item
How old was the patient at the onset of PLMS? Years (in whole years)
integer
C0206132 (UMLS CUI [1,1])
C0596840 (UMLS CUI [1,2])
C0037313 (UMLS CUI [2,1])
C0035258 (UMLS CUI [2,2])
Item
Does the patient drink alcohol?
text
C0001948 (UMLS CUI [1])
Alcohol
Code List
Does the patient drink alcohol?
CL Item
No (N)
CL Item
Yes (Y)
Alcohol Units/week
Item
Units/week
integer
C0001948 (UMLS CUI [1])
Item
Does the patient drink caffeine (coffee, tea, caffeinated drinks)?
text
C0948365 (UMLS CUI [1])
Caffeine
Code List
Does the patient drink caffeine (coffee, tea, caffeinated drinks)?
CL Item
No (N)
CL Item
Yes (Y)
Caffeine Cups/day
Item
Cups/day
integer
C0948365 (UMLS CUI [1])
Item
Does the patient have any sleep disorder as defined by DSM IV excluding RLS?
text
C0851578 (UMLS CUI [1])
Sleep disorders
Code List
Does the patient have any sleep disorder as defined by DSM IV excluding RLS?
CL Item
No (N)
CL Item
Yes (Y)
Item
Has any first degree relative (mother/father, brother/sister, son/daughter) of the patient ever been diagnosed with or had symptoms of RLS?
text
C0241889 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
Family history of RLS
Code List
Has any first degree relative (mother/father, brother/sister, son/daughter) of the patient ever been diagnosed with or had symptoms of RLS?
CL Item
No (N)
CL Item
Yes (Y)
CL Item
Unknown (U)
Item
Has any first degree relative (mother/father, brother/sister, son/daughter) of the patient ever ... been diagnosed with or had symptoms of PLMS?
text
C0241889 (UMLS CUI [1,1])
C0596840 (UMLS CUI [1,2])
C0037313 (UMLS CUI [1,3])
Family history of PLMS
Code List
Has any first degree relative (mother/father, brother/sister, son/daughter) of the patient ever ... been diagnosed with or had symptoms of PLMS?
CL Item
No (N)
CL Item
Yes (Y)
CL Item
Unknown (U)
Item
Are the patient’s current symptoms mainly present..
integer
C1457887 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
Presence of symptoms
Code List
Are the patient’s current symptoms mainly present..
CL Item
At nightime only (1)
CL Item
In evening and nightime (2)
CL Item
Daytime, evening and nightime (3)
Item Group
RLS Diagnostic Criteria
C0035258 (UMLS CUI-1)
C0679228 (UMLS CUI-2)
limb movement associated with paresthesias or dysesthesias
Item
A desire to move the limbs usually associated with paresthesias or dysesthesias
boolean
C0035258 (UMLS CUI [1,1])
C0596840 (UMLS CUI [1,2])
C0030554 (UMLS CUI [1,3])
C0392699 (UMLS CUI [1,4])
motor restlessness
Item
motor restlessness (during wakefulness does the patient move the limbs in attempt to relieve the discomfort)
boolean
C0700075 (UMLS CUI [1])
Symptoms at rest
Item
symptoms worse or exclusively present at rest with at least partial and temporal relief by activity
boolean
C1457887 (UMLS CUI [1,1])
C0035253 (UMLS CUI [1,2])
Symptoms in the evening or night
Item
symptoms worse in the evening or night
boolean
C3176727 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
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