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