ID
40467
Descripción
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
Palabras clave
Versiones (1)
- 23/4/20 23/4/20 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
23 de abril de 2020
DOI
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Licencia
Creative Commons BY-NC 4.0
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Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/218
Eligibility Criteria
- StudyEvent: ODM
Descripción
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Descripción
1. Is the patient male or female and diagnosed with RLS using IRLSSG diagnostic criteria with a history of a minimum of 15 nights of RLS symptoms per month?
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0079399
- UMLS CUI [2]
- C0035258
- UMLS CUI [3,1]
- C2348561
- UMLS CUI [3,2]
- C0679228
- UMLS CUI [4]
- C0439603
Descripción
2. Does the patient have a score of 15 or greater RLS Rating Scale at the baseline (Day 1) visit?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0681889
- UMLS CUI [1,2]
- C0035258
- UMLS CUI [1,3]
- C1442488
Descripción
3. Is the patient aged between 18 and 79 years old, inclusive?
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0001779
Descripción
4. Does the patient have a body mass index (BMI = weight kg/height m2) within the range 19 to 29 kg.m-2?
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1305855
Descripción
5. Has the patient given written informed consent prior to any specific study procedures being performed?
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0021430
- UMLS CUI [2,1]
- C0087111
- UMLS CUI [2,2]
- C0205369
Descripción
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Descripción
1. Does the patient suffer from RLS symptoms which require treatment during the daytime (daytime defined as 10:00 until 18:00)?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0035258
- UMLS CUI [2,1]
- C0332169
- UMLS CUI [2,2]
- C0087111
Descripción
2. Does the patient suffer from a primary sleep disorder other than RLS that may significantly affect the symptoms of RLS (e.g. narcolepsy, sleep terror disorder, sleep walking disorder and breathing related sleep disorder)?
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0236991
- UMLS CUI [2,1]
- C0035258
- UMLS CUI [2,2]
- C0205394
- UMLS CUI [3,1]
- C1457887
- UMLS CUI [3,2]
- C0035258
- UMLS CUI [4]
- C0027404
- UMLS CUI [5]
- C0851578
- UMLS CUI [6]
- C0037672
- UMLS CUI [7,1]
- C1260922
- UMLS CUI [7,2]
- C0037313
- UMLS CUI [7,3]
- C0439849
Descripción
3. Does the patient have signs of secondary RLS (e.g. renal failure (end-stage renal disease), iron deficient anaemia or pregnancy at baseline)?
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1536279
- UMLS CUI [2]
- C0035078
- UMLS CUI [3]
- C0022661
- UMLS CUI [4]
- C0162316
- UMLS CUI [5]
- C0032961
Descripción
4. Does the patient suffer from movement disorders (e.g. Parkinson’s disease, dyskinesias, and dystonias)?
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0026650
- UMLS CUI [2]
- C0030567
- UMLS CUI [3]
- C0013384
- UMLS CUI [4]
- C0013421
Descripción
5. Pharmaceutical Preparations | Drowsiness | Restless Legs Syndrome | Sleep | Discontinuation (procedure); Baseline; Before
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0013227
- UMLS CUI [2]
- C0013144
- UMLS CUI [3]
- C0035258
- UMLS CUI [4]
- C0037313
- UMLS CUI [5,1]
- C0457454
- UMLS CUI [5,2]
- C1442488
- UMLS CUI [5,3]
- C0332152
Descripción
6. Does the patient have diastolic blood pressure ≥110mmHg or ≤ 50mmHg OR systolic blood pressure ≥ 180mmHg or ≤ 90mmHg at baseline (Day 1 pre-dose)?
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0428883
- UMLS CUI [2]
- C0871470
- UMLS CUI [3]
- C1442488
Descripción
7. Does the patient have a history or presence of symptomatic orthostatic hypotension?
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0740482
Descripción
8. OTC - Over The Counter; Pharmaceutical Preparations | Before; Medication dose; First (number)
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C2709201
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [2,1]
- C0332152
- UMLS CUI [2,2]
- C3174092
- UMLS CUI [2,3]
- C0205435
Descripción
9. Has the patient exhibited intolerance to ropinirole or any dopamine agonist?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1744706
- UMLS CUI [1,2]
- C0244821
- UMLS CUI [2]
- C0178601
Descripción
10. Childbearing Potential | Contraceptive methods | Oral contraception | Female Sterilization | Intrauterine Devices | Vaginal contraceptive diaphragm (device); Spermicidal foam or jelly; condom use | Contraceptive methods; systemic therapy | Norplant
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C3831118
- UMLS CUI [2]
- C0700589
- UMLS CUI [3]
- C0029151
- UMLS CUI [4]
- C0015787
- UMLS CUI [5]
- C0021900
- UMLS CUI [6,1]
- C0042241
- UMLS CUI [6,2]
- C3843423
- UMLS CUI [6,3]
- C0679782
- UMLS CUI [7,1]
- C0700589
- UMLS CUI [7,2]
- C1515119
- UMLS CUI [8]
- C1145675
Descripción
11. Is the patient a female of child bearing potential who has a positive pregnancy test or who is lactating at screening or day 1 visit?
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C3831118
- UMLS CUI [2]
- C0240802
- UMLS CUI [3]
- C0006147
- UMLS CUI [4]
- C0220908
Descripción
12. DSM-IV; Alcohol abuse | DSM-IV; Drug abuse | Substance Dependence | alcohol units/day | alcohol units/week
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0220952
- UMLS CUI [1,2]
- C0085762
- UMLS CUI [2,1]
- C0220952
- UMLS CUI [2,2]
- C0013146
- UMLS CUI [3]
- C0038580
- UMLS CUI [4]
- C0560578
- UMLS CUI [5]
- C0560579
Descripción
13. Gastrointestinal Diseases | Liver diseases | Kidney Diseases | Other medical condition | Interferes with; drug absorption | C0521102 Interferes with; drug distribution (pharmacokinetics) | Interferes with; drug metabolism | Interferes with; drug elimination
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0017178
- UMLS CUI [2]
- C0023895
- UMLS CUI [3]
- C0022658
- UMLS CUI [4]
- C3843040
- UMLS CUI [5,1]
- C0521102
- UMLS CUI [5,2]
- C0678745
- UMLS CUI [6,1]
- C0521102
- UMLS CUI [6,2]
- C0699903
- UMLS CUI [7,1]
- C0521102
- UMLS CUI [7,2]
- C0683140
- UMLS CUI [8,1]
- C0521102
- UMLS CUI [8,2]
- C0683141
Descripción
14. Physical Examination; Abnormality | risk factors | Interferes with
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [2]
- C0035648
- UMLS CUI [3]
- C0521102
Descripción
15. Chemistry, Clinical; Hematologic Tests; Abnormality | Laboratory test finding; Normal Range | Age | risk factors
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0018941
- UMLS CUI [1,3]
- C1704258
- UMLS CUI [2,1]
- C0587081
- UMLS CUI [2,2]
- C0086715
- UMLS CUI [3]
- C0001779
- UMLS CUI [4]
- C0035648
Descripción
16. 12 lead ECG; Abnormality | risk factors; Interferes with
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [2,1]
- C0035648
- UMLS CUI [2,2]
- C0521102
Descripción
17. Does the patient have a positive urine test for drugs of abuse at screening?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0202274
- UMLS CUI [1,2]
- C1446409
Descripción
18. Will the patient, in the opinion of the Investigator, be non-compliant with the visit schedule or other study procedures?
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0457432
- UMLS CUI [2,1]
- C0545082
- UMLS CUI [2,2]
- C0086960
- UMLS CUI [3]
- C2700391
Descripción
19. Has the patient participated in a clinical trial with any drug within 3 months before the screening visit?
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C2348568
Descripción
20. Does the patient have positive hepatitis B surface antigen, hepatitis C antibodies and HIV - I/II antibody results at screening?
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0019168
- UMLS CUI [2]
- C0166049
- UMLS CUI [3]
- C0019683
Descripción
21. Withdraw (activity) | Hormone replacement therapy; Introduction - action | Hormone replacement therapy; Changed status | Drug inhibition of cytochrome p450 CYP1A2 enzyme | Drug induction of cytochrome p450 CYP1A2 enzyme
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C2349954
- UMLS CUI [2,1]
- C0282402
- UMLS CUI [2,2]
- C0579004
- UMLS CUI [3,1]
- C0282402
- UMLS CUI [3,2]
- C0443172
- UMLS CUI [4]
- C1827504
- UMLS CUI [5]
- C1827490
Descripción
22. Is the patient taking fluctuating doses of oestrogen in both HRT or oral contraception?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0279494
- UMLS CUI [1,2]
- C0678766
- UMLS CUI [1,3]
- C0231241
- UMLS CUI [2]
- C0282402
- UMLS CUI [3]
- C0029151
Descripción
23. Will participation in this study result in the patient having donated more than 1500mL blood in the previous 12 months?
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0005794
Descripción
Investigator's Signature
Alias
- UMLS CUI-1
- C2346576
Similar models
Eligibility Criteria
- StudyEvent: ODM
C0019994 (UMLS CUI [1,2])
C0035258 (UMLS CUI [2])
C2348561 (UMLS CUI [3,1])
C0679228 (UMLS CUI [3,2])
C0439603 (UMLS CUI [4])
C0035258 (UMLS CUI [1,2])
C1442488 (UMLS CUI [1,3])
C0087111 (UMLS CUI [2,1])
C0205369 (UMLS CUI [2,2])
C0035258 (UMLS CUI [1,2])
C0332169 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0035258 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C1457887 (UMLS CUI [3,1])
C0035258 (UMLS CUI [3,2])
C0027404 (UMLS CUI [4])
C0851578 (UMLS CUI [5])
C0037672 (UMLS CUI [6])
C1260922 (UMLS CUI [7,1])
C0037313 (UMLS CUI [7,2])
C0439849 (UMLS CUI [7,3])
C0035078 (UMLS CUI [2])
C0022661 (UMLS CUI [3])
C0162316 (UMLS CUI [4])
C0032961 (UMLS CUI [5])
C0030567 (UMLS CUI [2])
C0013384 (UMLS CUI [3])
C0013421 (UMLS CUI [4])
C0013144 (UMLS CUI [2])
C0035258 (UMLS CUI [3])
C0037313 (UMLS CUI [4])
C0457454 (UMLS CUI [5,1])
C1442488 (UMLS CUI [5,2])
C0332152 (UMLS CUI [5,3])
C0871470 (UMLS CUI [2])
C1442488 (UMLS CUI [3])
C0013227 (UMLS CUI [1,2])
C0332152 (UMLS CUI [2,1])
C3174092 (UMLS CUI [2,2])
C0205435 (UMLS CUI [2,3])
C0244821 (UMLS CUI [1,2])
C0178601 (UMLS CUI [2])
C0700589 (UMLS CUI [2])
C0029151 (UMLS CUI [3])
C0015787 (UMLS CUI [4])
C0021900 (UMLS CUI [5])
C0042241 (UMLS CUI [6,1])
C3843423 (UMLS CUI [6,2])
C0679782 (UMLS CUI [6,3])
C0700589 (UMLS CUI [7,1])
C1515119 (UMLS CUI [7,2])
C1145675 (UMLS CUI [8])
C0240802 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C0220908 (UMLS CUI [4])
C0085762 (UMLS CUI [1,2])
C0220952 (UMLS CUI [2,1])
C0013146 (UMLS CUI [2,2])
C0038580 (UMLS CUI [3])
C0560578 (UMLS CUI [4])
C0560579 (UMLS CUI [5])
C0023895 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C3843040 (UMLS CUI [4])
C0521102 (UMLS CUI [5,1])
C0678745 (UMLS CUI [5,2])
C0521102 (UMLS CUI [6,1])
C0699903 (UMLS CUI [6,2])
C0521102 (UMLS CUI [7,1])
C0683140 (UMLS CUI [7,2])
C0521102 (UMLS CUI [8,1])
C0683141 (UMLS CUI [8,2])
C1704258 (UMLS CUI [1,2])
C0035648 (UMLS CUI [2])
C0521102 (UMLS CUI [3])
C0018941 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C0587081 (UMLS CUI [2,1])
C0086715 (UMLS CUI [2,2])
C0001779 (UMLS CUI [3])
C0035648 (UMLS CUI [4])
C1704258 (UMLS CUI [1,2])
C0035648 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C1446409 (UMLS CUI [1,2])
C0545082 (UMLS CUI [2,1])
C0086960 (UMLS CUI [2,2])
C2700391 (UMLS CUI [3])
C0166049 (UMLS CUI [2])
C0019683 (UMLS CUI [3])
C0282402 (UMLS CUI [2,1])
C0579004 (UMLS CUI [2,2])
C0282402 (UMLS CUI [3,1])
C0443172 (UMLS CUI [3,2])
C1827504 (UMLS CUI [4])
C1827490 (UMLS CUI [5])
C0678766 (UMLS CUI [1,2])
C0231241 (UMLS CUI [1,3])
C0282402 (UMLS CUI [2])
C0029151 (UMLS CUI [3])
C0011008 (UMLS CUI [1,2])