ID
34988
Description
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
Keywords
Versions (1)
- 2/7/19 2/7/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
February 7, 2019
DOI
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License
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
Description
Please comlpete the follwing questions:
Alias
- UMLS CUI-1
- C1522634
- UMLS CUI-2
- C0205197
Description
If no, go to #3
Data type
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
Description
2. Are these feelings painful rather than just uncomfortable?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1140621
- UMLS CUI [1,2]
- C1527305
- UMLS CUI [1,3]
- C0030193
Description
2a. How would you describe these feelings or sensations?
Data type
text
Alias
- UMLS CUI [1,1]
- C1140621
- UMLS CUI [1,2]
- C1527305
- UMLS CUI [1,3]
- C0678257
Description
If yes, go to #3a. If no, go to #4.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1863322
- UMLS CUI [1,2]
- C0277814
- UMLS CUI [2,1]
- C1863322
- UMLS CUI [2,2]
- C0444334
Description
3a. Do these feelings in your legs ever become overwhelming to the point that you cannot resist moving your legs?
Data type
boolean
Alias
- UMLS CUI [1]
- C1863322
Description
Mark One If no to both questions #1 and #3, go to #15.
Data type
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
Description
If yes, go to #4a. If no, go to #5.
Data type
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
Description
If yes, go to #15. If no, go to #5.
Data type
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
Description
if no, go to #6 if don’t know, go to #5c
Data type
integer
Alias
- UMLS CUI [1,1]
- C0080331
- UMLS CUI [1,2]
- C0564405
- UMLS CUI [1,3]
- C1140621
- UMLS CUI [1,4]
- C1527305
Description
5a. How quickly do you get relief from walking?
Data type
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
Description
if don’t know, go to #5d
Data type
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
Description
if don’t know, go to #5d
Data type
integer
Alias
- UMLS CUI [1,1]
- C0561995
- UMLS CUI [1,2]
- C0564405
- UMLS CUI [1,3]
- C1140621
- UMLS CUI [1,4]
- C1527305
Description
5d. What do you do to get relief from these feelings?
Data type
text
Alias
- UMLS CUI [1,1]
- C0564405
- UMLS CUI [1,2]
- C1140621
- UMLS CUI [1,3]
- C1527305
Description
6. Are these feelings in your legs more likely to occur while you are resting then when you are physically active?
Data type
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
Description
If yes, go to #7a. If no, go to #8.
Data type
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
Description
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.
Data type
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
Description
If no, go to #8a.
Data type
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
Description
9. Approximately, how old were you when you first noticed these feelings in your legs?
Data type
integer
Measurement units
- years
Alias
- UMLS CUI [1,1]
- C2745955
- UMLS CUI [1,2]
- C0205435
- UMLS CUI [1,3]
- C1140621
- UMLS CUI [1,4]
- C1527305
Description
If yes, go to #11. If no, go to #10a.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1140621
- UMLS CUI [1,2]
- C1527305
- UMLS CUI [1,3]
- C0549178
Description
If yes, go to #11a. If no, go to #10b.
Data type
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
Description
10b.How long ago did these feelings stop?
Data type
integer
Measurement units
- years
Alias
- UMLS CUI [1,1]
- C1140621
- UMLS CUI [1,2]
- C1527305
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0449238
Description
Mark One
Data type
integer
Alias
- UMLS CUI [1,1]
- C1140621
- UMLS CUI [1,2]
- C1527305
- UMLS CUI [1,3]
- C4036195
- UMLS CUI [1,4]
- C0449238
Description
11b.Please respond to the following questions (12-14) for the period of time during which you had these feelings.
Data type
integer
Measurement units
- 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
Description
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.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1140621
- UMLS CUI [1,2]
- C1527305
- UMLS CUI [1,3]
- C0013227
Description
12. How many days in the month do (did) you have these feelings?
Data type
integer
Alias
- UMLS CUI [1,1]
- C1140621
- UMLS CUI [1,2]
- C1527305
- UMLS CUI [1,3]
- C0556971
Description
12. If < 1 per month, then how many times a year?
Data type
integer
Alias
- UMLS CUI [1,1]
- C1140621
- UMLS CUI [1,2]
- C1527305
- UMLS CUI [1,3]
- C0556970
Description
Note: Is the # of life events greater than 20? If yes, go to #12c. If no, go to #12b.
Data type
integer
Measurement units
- years
Alias
- UMLS CUI [1,1]
- C1140621
- UMLS CUI [1,2]
- C1527305
- UMLS CUI [1,3]
- C0449238
- UMLS CUI [1,4]
- C0439234
Description
12b.Did you ever have these feelings at least once a month for three consecutive months?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1140621
- UMLS CUI [1,2]
- C1527305
- UMLS CUI [1,3]
- C3845349
- UMLS CUI [1,4]
- C1707491
Description
12c.At what time of day do (did) these feelings usually start?
Data type
integer
Alias
- UMLS CUI [1,1]
- C1140621
- UMLS CUI [1,2]
- C1527305
- UMLS CUI [1,3]
- C0439548
- UMLS CUI [1,4]
- C1301880
Description
13. Are you aware of any medications or medical problems which might be causing (have caused) these feelings or making (made) these feelings worse?
Data type
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
Description
13a.(If yes) What is the medication or medical problem?
Data type
text
Alias
- UMLS CUI [1]
- C0013227
- UMLS CUI [2]
- C1254481
Description
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?
Data type
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
Description
14a.(If yes) Which problem(s)?
Data type
text
Alias
- UMLS CUI [1]
- C1254481
Description
End of the Interview
Alias
- UMLS CUI-1
- C0021822
- UMLS CUI-2
- C0444930
Description
if yes, go to #15a if no, go to #16
Data type
boolean
Alias
- UMLS CUI [1]
- C0393760
Description
15a.How often?
Data type
integer
Alias
- UMLS CUI [1,1]
- C0393760
- UMLS CUI [1,2]
- C0439603
Description
if no, go to #16
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1140621
- UMLS CUI [1,2]
- C4036195
- UMLS CUI [2,1]
- C0560560
- UMLS CUI [2,2]
- C1140621
Description
Enter the comments on the line
Data type
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
Description
If yes, go to #16a If no, interview is finished
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1170730
- UMLS CUI [1,2]
- C4086382
Description
16a.How often?
Data type
integer
Alias
- UMLS CUI [1]
- C0439603
Description
If yes, go to #16c If no, interview is finished
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1140621
- UMLS CUI [1,2]
- C4036195
- UMLS CUI [2,1]
- C0560560
- UMLS CUI [2,2]
- C1140621
Description
Enter the comments on the line
Data type
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
Description
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?
Data type
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
Description
17a.While you were pregnant, did you have the need or urge to move your legs while you were either sitting or lying down?
Data type
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])