ID
40467
Beschreibung
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
Stichworte
Versionen (1)
- 23.04.20 23.04.20 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
23. April 2020
DOI
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Lizenz
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
Beschreibung
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Beschreibung
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?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0079399
- UMLS CUI [2]
- C0035258
- UMLS CUI [3,1]
- C2348561
- UMLS CUI [3,2]
- C0679228
- UMLS CUI [4]
- C0439603
Beschreibung
2. Does the patient have a score of 15 or greater RLS Rating Scale at the baseline (Day 1) visit?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0681889
- UMLS CUI [1,2]
- C0035258
- UMLS CUI [1,3]
- C1442488
Beschreibung
3. Is the patient aged between 18 and 79 years old, inclusive?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0001779
Beschreibung
4. Does the patient have a body mass index (BMI = weight kg/height m2) within the range 19 to 29 kg.m-2?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1305855
Beschreibung
5. Has the patient given written informed consent prior to any specific study procedures being performed?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0021430
- UMLS CUI [2,1]
- C0087111
- UMLS CUI [2,2]
- C0205369
Beschreibung
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Beschreibung
1. Does the patient suffer from RLS symptoms which require treatment during the daytime (daytime defined as 10:00 until 18:00)?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0035258
- UMLS CUI [2,1]
- C0332169
- UMLS CUI [2,2]
- C0087111
Beschreibung
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)?
Datentyp
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
Beschreibung
3. Does the patient have signs of secondary RLS (e.g. renal failure (end-stage renal disease), iron deficient anaemia or pregnancy at baseline)?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1536279
- UMLS CUI [2]
- C0035078
- UMLS CUI [3]
- C0022661
- UMLS CUI [4]
- C0162316
- UMLS CUI [5]
- C0032961
Beschreibung
4. Does the patient suffer from movement disorders (e.g. Parkinson’s disease, dyskinesias, and dystonias)?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0026650
- UMLS CUI [2]
- C0030567
- UMLS CUI [3]
- C0013384
- UMLS CUI [4]
- C0013421
Beschreibung
5. Pharmaceutical Preparations | Drowsiness | Restless Legs Syndrome | Sleep | Discontinuation (procedure); Baseline; Before
Datentyp
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
Beschreibung
6. Does the patient have diastolic blood pressure ≥110mmHg or ≤ 50mmHg OR systolic blood pressure ≥ 180mmHg or ≤ 90mmHg at baseline (Day 1 pre-dose)?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0428883
- UMLS CUI [2]
- C0871470
- UMLS CUI [3]
- C1442488
Beschreibung
7. Does the patient have a history or presence of symptomatic orthostatic hypotension?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0740482
Beschreibung
8. OTC - Over The Counter; Pharmaceutical Preparations | Before; Medication dose; First (number)
Datentyp
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
Beschreibung
9. Has the patient exhibited intolerance to ropinirole or any dopamine agonist?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1744706
- UMLS CUI [1,2]
- C0244821
- UMLS CUI [2]
- C0178601
Beschreibung
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
Datentyp
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
Beschreibung
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?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C3831118
- UMLS CUI [2]
- C0240802
- UMLS CUI [3]
- C0006147
- UMLS CUI [4]
- C0220908
Beschreibung
12. DSM-IV; Alcohol abuse | DSM-IV; Drug abuse | Substance Dependence | alcohol units/day | alcohol units/week
Datentyp
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
Beschreibung
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
Datentyp
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
Beschreibung
14. Physical Examination; Abnormality | risk factors | Interferes with
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [2]
- C0035648
- UMLS CUI [3]
- C0521102
Beschreibung
15. Chemistry, Clinical; Hematologic Tests; Abnormality | Laboratory test finding; Normal Range | Age | risk factors
Datentyp
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
Beschreibung
16. 12 lead ECG; Abnormality | risk factors; Interferes with
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [2,1]
- C0035648
- UMLS CUI [2,2]
- C0521102
Beschreibung
17. Does the patient have a positive urine test for drugs of abuse at screening?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0202274
- UMLS CUI [1,2]
- C1446409
Beschreibung
18. Will the patient, in the opinion of the Investigator, be non-compliant with the visit schedule or other study procedures?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0457432
- UMLS CUI [2,1]
- C0545082
- UMLS CUI [2,2]
- C0086960
- UMLS CUI [3]
- C2700391
Beschreibung
19. Has the patient participated in a clinical trial with any drug within 3 months before the screening visit?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2348568
Beschreibung
20. Does the patient have positive hepatitis B surface antigen, hepatitis C antibodies and HIV - I/II antibody results at screening?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0019168
- UMLS CUI [2]
- C0166049
- UMLS CUI [3]
- C0019683
Beschreibung
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
Datentyp
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
Beschreibung
22. Is the patient taking fluctuating doses of oestrogen in both HRT or oral contraception?
Datentyp
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
Beschreibung
23. Will participation in this study result in the patient having donated more than 1500mL blood in the previous 12 months?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0005794
Beschreibung
Investigator's Signature
Alias
- UMLS CUI-1
- C2346576
Ähnliche Modelle
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])