ID
40518
Description
Study ID: 101468/218 Clinical Study ID: SKF-101468/218 Study Title:A Single-Blind, Randomised, Placebo-Controlled, Parallel-Group, Multicentre, Phase IIa Study to Determine the Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Restless Legs Syndrome
Mots-clés
Versions (2)
- 30/04/2020 30/04/2020 -
- 30/04/2020 30/04/2020 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
30 avril 2020
DOI
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Licence
Creative Commons BY-NC 4.0
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Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/218
Screening - Demography; RLS Diagnostic Criteria; Significant Medical/ Surgical History; Physical Examination
Description
Demography
Alias
- UMLS CUI-1
- C0011298
Description
Date of Birth
Type de données
date
Alias
- UMLS CUI [1]
- C0421451
Description
Gender
Type de données
text
Alias
- UMLS CUI [1]
- C0079399
Description
Race
Type de données
text
Alias
- UMLS CUI [1]
- C0034510
Description
Height
Type de données
integer
Unités de mesure
- cm
Alias
- UMLS CUI [1]
- C0005890
Description
Weight
Type de données
float
Unités de mesure
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
Body Mass Index
Type de données
float
Unités de mesure
- kg/m2
Alias
- UMLS CUI [1]
- C1305855
Description
RLS Diagnostic Criteria
Alias
- UMLS CUI-1
- C0035258
- UMLS CUI-2
- C0679228
Description
1. a desire to move the limbs usually associated with paresthesias or dysesthesias
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C0596840
- UMLS CUI [1,3]
- C0030554
- UMLS CUI [1,4]
- C0392699
Description
2. motor restlessness (during wakefulness does the patient move the limbs in attempt to relieve the discomfort
Type de données
boolean
Alias
- UMLS CUI [1]
- C0700075
- UMLS CUI [2,1]
- C0043012
- UMLS CUI [2,2]
- C0596840
- UMLS CUI [2,3]
- C2364135
- UMLS CUI [2,4]
- C0564405
Description
3. symptoms worse or exclusively present at rest with at least partial and temporal relief by activity
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C1457868
- UMLS CUI [1,3]
- C0443144
- UMLS CUI [2,1]
- C1457887
- UMLS CUI [2,2]
- C0443144
- UMLS CUI [3,1]
- C0564405
- UMLS CUI [3,2]
- C0728938
- UMLS CUI [3,3]
- C0026606
- UMLS CUI [4,1]
- C0564405
- UMLS CUI [4,2]
- C0205374
- UMLS CUI [4,3]
- C0026606
Description
4. symptoms worse in the evening or night
Type de données
boolean
Alias
- UMLS CUI [1]
- C3176727
Description
Significant Medical / Surgical History and Physical Examination
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0489540
- UMLS CUI-3
- C0031809
Description
If yes, List below one diagnosis per line. Only in the absence of a diagnosis, record the signs and symptoms on separate lines.
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0750502
- UMLS CUI [2,1]
- C0543467
- UMLS CUI [2,2]
- C0012634
- UMLS CUI [2,3]
- C0750502
Description
Significant Medical / Surgical History and Physical Examination
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0489540
- UMLS CUI-3
- C0031809
Description
Diagnosis
Type de données
text
Alias
- UMLS CUI [1]
- C0011900
Description
Year of first diagnosis
Type de données
partialDate
Alias
- UMLS CUI [1,1]
- C0439234
- UMLS CUI [1,2]
- C0011900
Description
Condition Status
Type de données
integer
Alias
- UMLS CUI [1]
- C3176928
Similar models
Screening - Demography; RLS Diagnostic Criteria; Significant Medical/ Surgical History; Physical Examination
C0019994 (UMLS CUI [1,2])
C0679228 (UMLS CUI-2)
C0596840 (UMLS CUI [1,2])
C0030554 (UMLS CUI [1,3])
C0392699 (UMLS CUI [1,4])
C0043012 (UMLS CUI [2,1])
C0596840 (UMLS CUI [2,2])
C2364135 (UMLS CUI [2,3])
C0564405 (UMLS CUI [2,4])
C1457868 (UMLS CUI [1,2])
C0443144 (UMLS CUI [1,3])
C1457887 (UMLS CUI [2,1])
C0443144 (UMLS CUI [2,2])
C0564405 (UMLS CUI [3,1])
C0728938 (UMLS CUI [3,2])
C0026606 (UMLS CUI [3,3])
C0564405 (UMLS CUI [4,1])
C0205374 (UMLS CUI [4,2])
C0026606 (UMLS CUI [4,3])
C0489540 (UMLS CUI-2)
C0031809 (UMLS CUI-3)
C0750502 (UMLS CUI [1,2])
C0543467 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C0750502 (UMLS CUI [2,3])
C0489540 (UMLS CUI-2)
C0031809 (UMLS CUI-3)
C0011900 (UMLS CUI [1,2])