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ID
27188
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Study ID: 101468/188 Clinical Study ID: SKF-101468/188 Study Title:A Study of the Maintained Efficacy and Safety of Ropinirole Versus Placebo in the Long Term Treatment of Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Requip Study Indication: Parkinson Disease Module: Screening
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Versies (1)
- 03-11-17 03-11-17 -
Houder van rechten
GlaxoSmithKline
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3 november 2017
DOI
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Licentie
Creative Commons BY-NC 3.0
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GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/188
Similar models
Screening
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Centre Number
Item
Centre Number
integer
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
C0019994 (UMLS CUI [1,2])
Patient Number
Item
Patient Number
integer
C1830427 (UMLS CUI [1])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
age of onset restless legs syndrome
Item
How old was the patient at the onset of RLS?
integer
C0035258 (UMLS CUI [1,1])
C0206132 (UMLS CUI [1,2])
C0206132 (UMLS CUI [1,2])
medication caused RLS
Item
Did the patient start any new medication near the time of their first onset of RLS symptoms that may have caused RLS?
boolean
C0035258 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,3])
medication caused RLS
Item
If ’Yes’ please specify medication(s)
text
C0013227 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,2])
Item
If female, did RLS symptoms develop during pregnancy?
integer
C0035258 (UMLS CUI [1,1])
C0032961 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0032961 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
Code List
If female, did RLS symptoms develop during pregnancy?
CL Item
No (1)
CL Item
Yes (2)
CL Item
Not applicable (3)
PLMS
Item
Has the patient ever had PLMS (Periodic Limb Movements during Sleep)?
boolean
C0596840 (UMLS CUI [1,1])
C0037313 (UMLS CUI [1,2])
C0035258 (UMLS CUI [2])
C0037313 (UMLS CUI [1,2])
C0035258 (UMLS CUI [2])
age of onset of PLMS
Item
If 'Yes': How old was the patient at the onset of PLMS?
integer
C0206132 (UMLS CUI [1,1])
C0596840 (UMLS CUI [1,2])
C0037313 (UMLS CUI [1,3])
C0035258 (UMLS CUI [2])
C0596840 (UMLS CUI [1,2])
C0037313 (UMLS CUI [1,3])
C0035258 (UMLS CUI [2])
alcohol consumption
Item
Does the patient drink alcohol?
boolean
C0001948 (UMLS CUI [1])
alcohol consumptions
Item
If 'Yes": Units/week
integer
C0001948 (UMLS CUI [1,1])
C0560579 (UMLS CUI [1,2])
C0560579 (UMLS CUI [1,2])
consumption of caffeine
Item
Does the patient drink caffeine (coffee, tea, caffeinated drinks)?
boolean
C0948365 (UMLS CUI [1])
consumption of caffeine
Item
If 'Yes': Cups/day
integer
C0948365 (UMLS CUI [1])
sleep disorder
Item
Does the patient have any sleep disorder as defined by DSM IV?
boolean
C0851578 (UMLS CUI [1,1])
C0220952 (UMLS CUI [1,2])
C0220952 (UMLS CUI [1,2])
Item
Has any first degree relative (mother/father, brother/sister, son/daughter) of the patient ever been diagnosed with or had symptoms of RLS?
integer
C1517194 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,2])
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 (1)
CL Item
Yes (2)
CL Item
Unknown (3)
Item
Are the patient’s current symptoms mainly present ...
integer
C1457887 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0035258 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
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)
C0679228 (UMLS CUI-2)
desire to move the limbs usually associated with parethesias or dysesthesias
Item
1)...a desire to move the limbs usually associated with parethesias or dysesthesias
boolean
C0596840 (UMLS CUI [1])
C0030554 (UMLS CUI [2])
C0392699 (UMLS CUI [3])
C0035258 (UMLS CUI [4])
C0030554 (UMLS CUI [2])
C0392699 (UMLS CUI [3])
C0035258 (UMLS CUI [4])
motor restlessness
Item
2)...motor restlessness (during wakefulness does the patient move the limbs in attempt to relieve the discomfort)
boolean
C0700075 (UMLS CUI [1])
symptoms worse at rest with at least partial or temporal relief by activity
Item
3) ...symptoms worse or exclusively present at rest with at least partial or temporal relief by activity
boolean
C0035258 (UMLS CUI [1,1])
C0026606 (UMLS CUI [1,2])
C0564405 (UMLS CUI [1,3])
C0026606 (UMLS CUI [1,2])
C0564405 (UMLS CUI [1,3])
symptoms worse in the evening or night
Item
4) ...symptoms worse in the evening or night
boolean
C3176727 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,2])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
CL Item
Male (M)
CL Item
Female (F)
CL Item
White (1)
CL Item
Black (2)
CL Item
Oriental (3)
CL Item
Other (4)
Race
Item
Race, if other please specify
text
C0034510 (UMLS CUI [1])
Height
Item
Height
float
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Sitting blood pressure systolic
Item
Sitting blood pressure systolic
integer
C0871470 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
C0277814 (UMLS CUI [1,2])
Sitting blood pressure diastolic
Item
Sitting blood pressure diastolic
integer
C0428883 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
C0277814 (UMLS CUI [1,2])
Sitting heart rate
Item
Sitting heart rate
integer
C0018810 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
C0277814 (UMLS CUI [1,2])
Date of ECG
Item
Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
ECG abnormalities
Item
Were any clinically significant abnormalities detected?
boolean
C0522055 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
Date of blood sample
Item
Date of blood sample
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
laboratory abnormalities
Item
Were any clinically significant abnormalities detected?
boolean
C1853129 (UMLS CUI [1])
Item
What was the result of the urine dipstick performed at this visit?
integer
C0430370 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
C0456984 (UMLS CUI [1,2])
Code List
What was the result of the urine dipstick performed at this visit?
CL Item
Negative (1)
CL Item
Positive (2)
child-bearing potential
Item
Is the patient a female of child-bearing potential?
boolean
C1960468 (UMLS CUI [1])
Item
Pregnancy dipstick test result
integer
C0427777 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
C0430370 (UMLS CUI [1,2])
CL Item
Negative (1)
CL Item
Positive (2)
Item Group
Significant medical/surgical history and physical examination
C0262926 (UMLS CUI-1)
C0031809 (UMLS CUI-2)
C0012634 (UMLS CUI-3)
C0031809 (UMLS CUI-2)
C0012634 (UMLS CUI-3)
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
medical or surgical condition
Item
Is the patient suffering from or has he/she suffered from any significant medical or surgical condition?
boolean
C0012634 (UMLS CUI [1])
C0009488 (UMLS CUI [2])
C0009488 (UMLS CUI [2])
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1,1])
C0009488 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,2])
Year of first diagnosis
Item
Year of first diagnosis
partialDate
C0011900 (UMLS CUI [1,1])
C0439234 (UMLS CUI [1,2])
C0439234 (UMLS CUI [1,2])
Item
Medical condition ongoing
integer
C0012634 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
CL Item
Past (1)
CL Item
Ongoing (2)
CL Item
Past + Ongoing (3)
Item Group
Prior and concomitant medication
C2347852 (UMLS CUI-1)
C0013227 (UMLS CUI-2)
C2826257 (UMLS CUI-3)
C0013227 (UMLS CUI-2)
C2826257 (UMLS CUI-3)
medication
Item
Has the patient taken any medication (excluding any pharmacotherapy medication for treatment of RLS) in the 3 months prior to study entry?
boolean
C0013227 (UMLS CUI [1])
Drug Name
Item
Drug Name (Trade Name Preferred)
text
C2360065 (UMLS CUI [1])
Total Daily Dose
Item
Total Daily Dose
float
C2348070 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
Medical Illness/Diagnosis
Item
Medical Illness/Diagnosis
text
C0011900 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,3])
Start Date of medication
Item
Start Date of medication (be as precise as possible)
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
End Date of medication
Item
End Date of medication
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
Medication continuing?
Item
Medication continuing?
boolean
C0013227 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
Item Group
RLS pharmacotherapy history
C0013216 (UMLS CUI-1)
C0035258 (UMLS CUI-2)
C0035258 (UMLS CUI-2)
pharmacotherapy medication for treatment of RLS
Item
Has the patient taken any pharmacotherapy medication for treatment of RLS?
boolean
C0013216 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,2])
Drug Name
Item
Drug Name (Trade Name Preferred)
text
C2360065 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
C0013216 (UMLS CUI [1,2])
Start Date pharmacotherapy
Item
Start Date pharmacotherapy (be as precise as possible)
date
C0013216 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
End Date pharmacotherapy
Item
End Date pharmacotherapy
date
C0013216 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
Medication continuing?
Item
Medication continuing?
boolean
C0013216 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
Item
Did the patient respond to the treatment?
integer
C0521982 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
C0013216 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
CL Item
No (1)
CL Item
Yes (2)
CL Item
Unknown (3)
Item
Did the patient tolerate the treatment?
integer
C0013220 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
C0013216 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
CL Item
No (1)
CL Item
Yes (2)
CL Item
Unknown (3)
Item Group
Screening Inclusion/Exclusion Criteria
C1710477 (UMLS CUI-1)
C0013893 (UMLS CUI-2)
C0013893 (UMLS CUI-2)
diagnosed with RLS
Item
Patient is diagnosed with RLS using IRLSSG diagnostic criteria with a history of a minimum of 15 nights of RLS symptoms during the previous month. In the case of a patient currently receiving medication for the treatment of RLS, the Investigator should use their clinical judgement to assess whether that patient would have suffered from a minimum of 15 nights with RLS symptoms if they had not been taking any medication.
boolean
C0035258 (UMLS CUI [1])
C1512693 (UMLS CUI [2])
C1512693 (UMLS CUI [2])
age
Item
Patient is ≥ 18 years old and < 80 years of age.
boolean
C0001779 (UMLS CUI [1])
C1512693 (UMLS CUI [2])
C1512693 (UMLS CUI [2])
informed consent
Item
Patient has given written informed consent prior to any specific study procedures.
boolean
C0021430 (UMLS CUI [1])
C1512693 (UMLS CUI [2])
C1512693 (UMLS CUI [2])
RLS symptoms daytime
Item
Patient is suffering from RLS symptoms which require treatment during the daytime (daytime defined as 10.00 until 18.00).
boolean
C0035258 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0332169 (UMLS CUI [1,3])
C0680251 (UMLS CUI [2])
C1457887 (UMLS CUI [1,2])
C0332169 (UMLS CUI [1,3])
C0680251 (UMLS CUI [2])
primary sleep disorder
Item
Patient suffers from a primary sleep disorder other than RLS that may significantly affect the symptoms of RLS (e.g. narcolepsy, sleep terror disorder, sleepwalking disorder, breathing related sleep disorder).
boolean
C0236991 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
C0680251 (UMLS CUI [2])
movement disorder
Item
Patient is suffering from a movement disorder (e.g. Parkinson’s Disease, dyskinesias or dystonias).
boolean
C0026650 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
C0680251 (UMLS CUI [2])
medical conditions with symptoms which could affect assessments of efficacy
Item
Patient has medical conditions with symptoms which could affect assessments of efficacy (e.g. diabetes, peripheral neuropathy, rheumatoid arthritis, fibromyalgia syndrome, etc.).
boolean
C0009488 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C1280519 (UMLS CUI [1,3])
C0680251 (UMLS CUI [2])
C0392760 (UMLS CUI [1,2])
C1280519 (UMLS CUI [1,3])
C0680251 (UMLS CUI [2])
intolerance to dopamine agonist
Item
Patient has exhibited intolerance to ropinirole or any other dopamine agonist.
boolean
C0020517 (UMLS CUI [1,1])
C0178601 (UMLS CUI [1,2])
C0680251 (UMLS CUI [2])
C0178601 (UMLS CUI [1,2])
C0680251 (UMLS CUI [2])
substance abuse
Item
Patient meets DSM-IV criteria for substance abuse (alcohol or drugs) or substance dependence within 6 months prior to Screening
boolean
C0038586 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
C0680251 (UMLS CUI [2])
contraception
Item
Patient is a woman, of childbearing potential who is not practising a clinically accepted method of contraception such as oral contraception, surgical sterilisation, IUD, diaphragm in conjunction with spermicidal foam and condom on the male partner, or systemic contraception (i.e., Norplant). Please refer to document: CD-5.5, Informed Consent (Phase I-IV), section entitled ’Recommendations For Use of Women Of Childbearing Potential in Clinical Research Studies for SmithKline Beecham’
boolean
C0420837 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
C0680251 (UMLS CUI [2])
positive pregnancy test or is lactating
Item
Patient is a woman who has a positive pregnancy test or is lactating.
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
C0680251 (UMLS CUI [2])
C0006147 (UMLS CUI [1,2])
C0680251 (UMLS CUI [2])
medical conditions
Item
Patient has clinically significant or unstable medical conditions which in the opinion of the investigator would render the patient unsuitable for the study (e.g. symptomatic orthostatic hypotension, severe cardiovascular disease, hepatic or renal failure, etc.).
boolean
C0012634 (UMLS CUI [1,1])
C0009488 (UMLS CUI [1,2])
C0680251 (UMLS CUI [2])
C0009488 (UMLS CUI [1,2])
C0680251 (UMLS CUI [2])
non-compliant
Item
Patient who, in the opinion of the Investigator, would be non-compliant with the visit schedule or other study procedures.
boolean
C1321605 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
C0680251 (UMLS CUI [2])
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