ID
34988
Beskrivning
Study ID: 101468/205 Clinical Study ID: 101468/205 Study Title:A 12-Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole XR (Extended Release) in Patients with Restless Legs Syndrome Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00197080 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
Nyckelord
Versioner (1)
- 2019-02-07 2019-02-07 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
7 februari 2019
DOI
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Licens
Creative Commons BY-NC 3.0
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Efficacy and Safety of Ropinirole XR (Extended Release) in Patients with Restless Legs Syndrome NCT00197080
Screening - RLS Diagnostic Clinical Interview
- StudyEvent: ODM
Beskrivning
Please comlpete the follwing questions:
Alias
- UMLS CUI-1
- C1522634
- UMLS CUI-2
- C0205197
Beskrivning
If no, go to #3
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1140621
- UMLS CUI [1,2]
- C1527305
- UMLS CUI [1,3]
- C4062607
- UMLS CUI [1,4]
- C0277814
- UMLS CUI [2,1]
- C1140621
- UMLS CUI [2,2]
- C1527305
- UMLS CUI [2,3]
- C4062607
- UMLS CUI [2,4]
- C0444334
Beskrivning
2. Are these feelings painful rather than just uncomfortable?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1140621
- UMLS CUI [1,2]
- C1527305
- UMLS CUI [1,3]
- C0030193
Beskrivning
2a. How would you describe these feelings or sensations?
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1140621
- UMLS CUI [1,2]
- C1527305
- UMLS CUI [1,3]
- C0678257
Beskrivning
If yes, go to #3a. If no, go to #4.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1863322
- UMLS CUI [1,2]
- C0277814
- UMLS CUI [2,1]
- C1863322
- UMLS CUI [2,2]
- C0444334
Beskrivning
3a. Do these feelings in your legs ever become overwhelming to the point that you cannot resist moving your legs?
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1863322
Beskrivning
Mark One If no to both questions #1 and #3, go to #15.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1140621
- UMLS CUI [1,2]
- C1527305
- UMLS CUI [1,3]
- C0558185
- UMLS CUI [1,4]
- C1280500
- UMLS CUI [2,1]
- C1140621
- UMLS CUI [2,2]
- C1527305
- UMLS CUI [2,3]
- C1948035
- UMLS CUI [2,4]
- C1280500
Beskrivning
If yes, go to #4a. If no, go to #5.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1140621
- UMLS CUI [1,2]
- C1527305
- UMLS CUI [1,3]
- C0277823
- UMLS CUI [2,1]
- C1140621
- UMLS CUI [2,2]
- C1527305
- UMLS CUI [2,3]
- C0026821
Beskrivning
If yes, go to #15. If no, go to #5.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1140621
- UMLS CUI [1,2]
- C1527305
- UMLS CUI [1,3]
- C0277823
- UMLS CUI [1,4]
- C2003902
- UMLS CUI [2,1]
- C1140621
- UMLS CUI [2,2]
- C1527305
- UMLS CUI [2,3]
- C0026821
- UMLS CUI [2,4]
- C2003902
Beskrivning
if no, go to #6 if don’t know, go to #5c
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0080331
- UMLS CUI [1,2]
- C0564405
- UMLS CUI [1,3]
- C1140621
- UMLS CUI [1,4]
- C1527305
Beskrivning
5a. How quickly do you get relief from walking?
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0080331
- UMLS CUI [1,2]
- C0564405
- UMLS CUI [1,3]
- C1140621
- UMLS CUI [1,4]
- C1527305
- UMLS CUI [1,5]
- C0456962
Beskrivning
if don’t know, go to #5d
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0080331
- UMLS CUI [1,2]
- C0549178
- UMLS CUI [1,3]
- C1140621
- UMLS CUI [1,4]
- C1527305
- UMLS CUI [1,5]
- C0034897
Beskrivning
if don’t know, go to #5d
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0561995
- UMLS CUI [1,2]
- C0564405
- UMLS CUI [1,3]
- C1140621
- UMLS CUI [1,4]
- C1527305
Beskrivning
5d. What do you do to get relief from these feelings?
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0564405
- UMLS CUI [1,2]
- C1140621
- UMLS CUI [1,3]
- C1527305
Beskrivning
6. Are these feelings in your legs more likely to occur while you are resting then when you are physically active?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1140621
- UMLS CUI [1,2]
- C1527305
- UMLS CUI [1,3]
- C2745955
- UMLS CUI [1,4]
- C0035253
- UMLS CUI [2,1]
- C1140621
- UMLS CUI [2,2]
- C1527305
- UMLS CUI [2,3]
- C2745955
- UMLS CUI [2,4]
- C0556453
Beskrivning
If yes, go to #7a. If no, go to #8.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1140621
- UMLS CUI [1,2]
- C1527305
- UMLS CUI [1,3]
- C0277814
- UMLS CUI [1,4]
- C1457868
- UMLS CUI [2,1]
- C1140621
- UMLS CUI [2,2]
- C1527305
- UMLS CUI [2,3]
- C0444334
- UMLS CUI [2,4]
- C1457868
Beskrivning
7a. Would it be true to say that you have these feelings almost exclusively when you are sitting and only rarely, if ever, when lying down.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1140621
- UMLS CUI [1,2]
- C1527305
- UMLS CUI [1,3]
- C1548966
- UMLS CUI [1,4]
- C0277814
- UMLS CUI [2,1]
- C1140621
- UMLS CUI [2,2]
- C1527305
- UMLS CUI [2,3]
- C0522498
- UMLS CUI [2,4]
- C0444334
Beskrivning
If no, go to #8a.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C3176727
- UMLS CUI [1,2]
- C1140621
- UMLS CUI [1,3]
- C1527305
- UMLS CUI [2,1]
- C1457868
- UMLS CUI [2,2]
- C0587117
- UMLS CUI [2,3]
- C1140621
- UMLS CUI [2,4]
- C1527305
Beskrivning
9. Approximately, how old were you when you first noticed these feelings in your legs?
Datatyp
integer
Måttenheter
- years
Alias
- UMLS CUI [1,1]
- C2745955
- UMLS CUI [1,2]
- C0205435
- UMLS CUI [1,3]
- C1140621
- UMLS CUI [1,4]
- C1527305
Beskrivning
If yes, go to #11. If no, go to #10a.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1140621
- UMLS CUI [1,2]
- C1527305
- UMLS CUI [1,3]
- C0549178
Beskrivning
If yes, go to #11a. If no, go to #10b.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1140621
- UMLS CUI [1,2]
- C1527305
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0087111
- UMLS CUI [1,5]
- C0678226
Beskrivning
10b.How long ago did these feelings stop?
Datatyp
integer
Måttenheter
- years
Alias
- UMLS CUI [1,1]
- C1140621
- UMLS CUI [1,2]
- C1527305
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0449238
Beskrivning
Mark One
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1140621
- UMLS CUI [1,2]
- C1527305
- UMLS CUI [1,3]
- C4036195
- UMLS CUI [1,4]
- C0449238
Beskrivning
11b.Please respond to the following questions (12-14) for the period of time during which you had these feelings.
Datatyp
integer
Måttenheter
- weeks or months or years
Alias
- UMLS CUI [1,1]
- C1140621
- UMLS CUI [1,2]
- C1527305
- UMLS CUI [1,3]
- C4036195
- UMLS CUI [1,4]
- C0449238
Beskrivning
If yes please respond to the following questions (12) the way you think you would be if you were not on any treatment at this time. If no, go to #12.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1140621
- UMLS CUI [1,2]
- C1527305
- UMLS CUI [1,3]
- C0013227
Beskrivning
12. How many days in the month do (did) you have these feelings?
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1140621
- UMLS CUI [1,2]
- C1527305
- UMLS CUI [1,3]
- C0556971
Beskrivning
12. If < 1 per month, then how many times a year?
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1140621
- UMLS CUI [1,2]
- C1527305
- UMLS CUI [1,3]
- C0556970
Beskrivning
Note: Is the # of life events greater than 20? If yes, go to #12c. If no, go to #12b.
Datatyp
integer
Måttenheter
- years
Alias
- UMLS CUI [1,1]
- C1140621
- UMLS CUI [1,2]
- C1527305
- UMLS CUI [1,3]
- C0449238
- UMLS CUI [1,4]
- C0439234
Beskrivning
12b.Did you ever have these feelings at least once a month for three consecutive months?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1140621
- UMLS CUI [1,2]
- C1527305
- UMLS CUI [1,3]
- C3845349
- UMLS CUI [1,4]
- C1707491
Beskrivning
12c.At what time of day do (did) these feelings usually start?
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1140621
- UMLS CUI [1,2]
- C1527305
- UMLS CUI [1,3]
- C0439548
- UMLS CUI [1,4]
- C1301880
Beskrivning
13. Are you aware of any medications or medical problems which might be causing (have caused) these feelings or making (made) these feelings worse?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C1140621
- UMLS CUI [1,4]
- C1527305
- UMLS CUI [2,1]
- C1254481
- UMLS CUI [2,2]
- C0085978
- UMLS CUI [2,3]
- C1140621
- UMLS CUI [2,4]
- C1527305
Beskrivning
13a.(If yes) What is the medication or medical problem?
Datatyp
text
Alias
- UMLS CUI [1]
- C0013227
- UMLS CUI [2]
- C1254481
Beskrivning
14. At the time you first developed these feelings did you have any problems with anemia, iron deficiency, nerve damage in your legs or feet, or pregnancy?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1140621
- UMLS CUI [1,2]
- C1527305
- UMLS CUI [2]
- C0002871
- UMLS CUI [3]
- C0240066
- UMLS CUI [4,1]
- C0161479
- UMLS CUI [4,2]
- C1140621
- UMLS CUI [4,3]
- C0016504
- UMLS CUI [5]
- C0032961
Beskrivning
14a.(If yes) Which problem(s)?
Datatyp
text
Alias
- UMLS CUI [1]
- C1254481
Beskrivning
End of the Interview
Alias
- UMLS CUI-1
- C0021822
- UMLS CUI-2
- C0444930
Beskrivning
if yes, go to #15a if no, go to #16
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0393760
Beskrivning
15a.How often?
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0393760
- UMLS CUI [1,2]
- C0439603
Beskrivning
if no, go to #16
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1140621
- UMLS CUI [1,2]
- C4036195
- UMLS CUI [2,1]
- C0560560
- UMLS CUI [2,2]
- C1140621
Beskrivning
Enter the comments on the line
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1140621
- UMLS CUI [1,2]
- C4036195
- UMLS CUI [1,3]
- C0085978
- UMLS CUI [2,1]
- C0560560
- UMLS CUI [2,2]
- C1140621
- UMLS CUI [2,3]
- C0392360
Beskrivning
If yes, go to #16a If no, interview is finished
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1170730
- UMLS CUI [1,2]
- C4086382
Beskrivning
16a.How often?
Datatyp
integer
Alias
- UMLS CUI [1]
- C0439603
Beskrivning
If yes, go to #16c If no, interview is finished
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1140621
- UMLS CUI [1,2]
- C4036195
- UMLS CUI [2,1]
- C0560560
- UMLS CUI [2,2]
- C1140621
Beskrivning
Enter the comments on the line
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1140621
- UMLS CUI [1,2]
- C4036195
- UMLS CUI [1,3]
- C0085978
- UMLS CUI [2,1]
- C0560560
- UMLS CUI [2,2]
- C1140621
- UMLS CUI [2,3]
- C0392360
Beskrivning
17. While you were pregnant, did you have unpleasant or uncomfortable feelings in your legs that occurred while you were either sitting or lying down?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0032961
- UMLS CUI [1,2]
- C1140621
- UMLS CUI [1,3]
- C1527305
- UMLS CUI [1,4]
- C0277814
- UMLS CUI [2,1]
- C0032961
- UMLS CUI [2,2]
- C1140621
- UMLS CUI [2,3]
- C1527305
- UMLS CUI [2,4]
- C0444334
Beskrivning
17a.While you were pregnant, did you have the need or urge to move your legs while you were either sitting or lying down?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0032961
- UMLS CUI [1,2]
- C1863322
- UMLS CUI [1,3]
- C0277814
- UMLS CUI [2,1]
- C0032961
- UMLS CUI [2,2]
- C1863322
- UMLS CUI [2,3]
- C0444334
Similar models
Screening - RLS Diagnostic Clinical Interview
- StudyEvent: ODM
C0085978 (UMLS CUI [1,2])
C0205197 (UMLS CUI-2)
C1527305 (UMLS CUI [1,2])
C4062607 (UMLS CUI [1,3])
C0277814 (UMLS CUI [1,4])
C1140621 (UMLS CUI [2,1])
C1527305 (UMLS CUI [2,2])
C4062607 (UMLS CUI [2,3])
C0444334 (UMLS CUI [2,4])
C1527305 (UMLS CUI [1,2])
C0030193 (UMLS CUI [1,3])
C1527305 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
C0277814 (UMLS CUI [1,2])
C1863322 (UMLS CUI [2,1])
C0444334 (UMLS CUI [2,2])
C1527305 (UMLS CUI [1,2])
C0558185 (UMLS CUI [1,3])
C1280500 (UMLS CUI [1,4])
C1140621 (UMLS CUI [2,1])
C1527305 (UMLS CUI [2,2])
C1948035 (UMLS CUI [2,3])
C1280500 (UMLS CUI [2,4])
C1527305 (UMLS CUI [1,2])
C0277823 (UMLS CUI [1,3])
C1140621 (UMLS CUI [2,1])
C1527305 (UMLS CUI [2,2])
C0026821 (UMLS CUI [2,3])
C1527305 (UMLS CUI [1,2])
C0277823 (UMLS CUI [1,3])
C2003902 (UMLS CUI [1,4])
C1140621 (UMLS CUI [2,1])
C1527305 (UMLS CUI [2,2])
C0026821 (UMLS CUI [2,3])
C2003902 (UMLS CUI [2,4])
C0564405 (UMLS CUI [1,2])
C1140621 (UMLS CUI [1,3])
C1527305 (UMLS CUI [1,4])
C0564405 (UMLS CUI [1,2])
C1140621 (UMLS CUI [1,3])
C1527305 (UMLS CUI [1,4])
C0456962 (UMLS CUI [1,5])
C0549178 (UMLS CUI [1,2])
C1140621 (UMLS CUI [1,3])
C1527305 (UMLS CUI [1,4])
C0034897 (UMLS CUI [1,5])
C0564405 (UMLS CUI [1,2])
C1140621 (UMLS CUI [1,3])
C1527305 (UMLS CUI [1,4])
C1140621 (UMLS CUI [1,2])
C1527305 (UMLS CUI [1,3])
C1527305 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
C0035253 (UMLS CUI [1,4])
C1140621 (UMLS CUI [2,1])
C1527305 (UMLS CUI [2,2])
C2745955 (UMLS CUI [2,3])
C0556453 (UMLS CUI [2,4])
C1527305 (UMLS CUI [1,2])
C0277814 (UMLS CUI [1,3])
C1457868 (UMLS CUI [1,4])
C1140621 (UMLS CUI [2,1])
C1527305 (UMLS CUI [2,2])
C0444334 (UMLS CUI [2,3])
C1457868 (UMLS CUI [2,4])
C1527305 (UMLS CUI [1,2])
C1548966 (UMLS CUI [1,3])
C0277814 (UMLS CUI [1,4])
C1140621 (UMLS CUI [2,1])
C1527305 (UMLS CUI [2,2])
C0522498 (UMLS CUI [2,3])
C0444334 (UMLS CUI [2,4])
C1140621 (UMLS CUI [1,2])
C1527305 (UMLS CUI [1,3])
C1457868 (UMLS CUI [2,1])
C0587117 (UMLS CUI [2,2])
C1140621 (UMLS CUI [2,3])
C1527305 (UMLS CUI [2,4])
C0205435 (UMLS CUI [1,2])
C1140621 (UMLS CUI [1,3])
C1527305 (UMLS CUI [1,4])
C1527305 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
C1527305 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
C0678226 (UMLS CUI [1,5])
C1527305 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0449238 (UMLS CUI [1,4])
C1527305 (UMLS CUI [1,2])
C4036195 (UMLS CUI [1,3])
C0449238 (UMLS CUI [1,4])
C1527305 (UMLS CUI [1,2])
C4036195 (UMLS CUI [1,3])
C0449238 (UMLS CUI [1,4])
C1527305 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C1527305 (UMLS CUI [1,2])
C0556971 (UMLS CUI [1,3])
C1527305 (UMLS CUI [1,2])
C0556970 (UMLS CUI [1,3])
C1527305 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
C0439234 (UMLS CUI [1,4])
C1527305 (UMLS CUI [1,2])
C3845349 (UMLS CUI [1,3])
C1707491 (UMLS CUI [1,4])
C1527305 (UMLS CUI [1,2])
C0439548 (UMLS CUI [1,3])
C1301880 (UMLS CUI [1,4])
C0085978 (UMLS CUI [1,2])
C1140621 (UMLS CUI [1,3])
C1527305 (UMLS CUI [1,4])
C1254481 (UMLS CUI [2,1])
C0085978 (UMLS CUI [2,2])
C1140621 (UMLS CUI [2,3])
C1527305 (UMLS CUI [2,4])
C1254481 (UMLS CUI [2])
C1527305 (UMLS CUI [1,2])
C0002871 (UMLS CUI [2])
C0240066 (UMLS CUI [3])
C0161479 (UMLS CUI [4,1])
C1140621 (UMLS CUI [4,2])
C0016504 (UMLS CUI [4,3])
C0032961 (UMLS CUI [5])
C4036195 (UMLS CUI [1,2])
C0560560 (UMLS CUI [2,1])
C1140621 (UMLS CUI [2,2])
C4036195 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,3])
C0560560 (UMLS CUI [2,1])
C1140621 (UMLS CUI [2,2])
C0392360 (UMLS CUI [2,3])
C4086382 (UMLS CUI [1,2])
C4036195 (UMLS CUI [1,2])
C0560560 (UMLS CUI [2,1])
C1140621 (UMLS CUI [2,2])
C4036195 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,3])
C0560560 (UMLS CUI [2,1])
C1140621 (UMLS CUI [2,2])
C0392360 (UMLS CUI [2,3])
C1140621 (UMLS CUI [1,2])
C1527305 (UMLS CUI [1,3])
C0277814 (UMLS CUI [1,4])
C0032961 (UMLS CUI [2,1])
C1140621 (UMLS CUI [2,2])
C1527305 (UMLS CUI [2,3])
C0444334 (UMLS CUI [2,4])
C1863322 (UMLS CUI [1,2])
C0277814 (UMLS CUI [1,3])
C0032961 (UMLS CUI [2,1])
C1863322 (UMLS CUI [2,2])
C0444334 (UMLS CUI [2,3])