ID
40467
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
Keywords
Versions (1)
- 4/23/20 4/23/20 -
Copyright Holder
GlaxoSmithKline
Uploaded on
April 23, 2020
DOI
To request one please log in.
License
Creative Commons BY-NC 4.0
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/218
Eligibility Criteria
- StudyEvent: ODM
Description
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Description
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?
Data type
boolean
Alias
- UMLS CUI [1]
- C0079399
- UMLS CUI [2]
- C0035258
- UMLS CUI [3,1]
- C2348561
- UMLS CUI [3,2]
- C0679228
- UMLS CUI [4]
- C0439603
Description
2. Does the patient have a score of 15 or greater RLS Rating Scale at the baseline (Day 1) visit?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0681889
- UMLS CUI [1,2]
- C0035258
- UMLS CUI [1,3]
- C1442488
Description
3. Is the patient aged between 18 and 79 years old, inclusive?
Data type
boolean
Alias
- UMLS CUI [1]
- C0001779
Description
4. Does the patient have a body mass index (BMI = weight kg/height m2) within the range 19 to 29 kg.m-2?
Data type
boolean
Alias
- UMLS CUI [1]
- C1305855
Description
5. Has the patient given written informed consent prior to any specific study procedures being performed?
Data type
boolean
Alias
- UMLS CUI [1]
- C0021430
- UMLS CUI [2,1]
- C0087111
- UMLS CUI [2,2]
- C0205369
Description
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Description
1. Does the patient suffer from RLS symptoms which require treatment during the daytime (daytime defined as 10:00 until 18:00)?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0035258
- UMLS CUI [2,1]
- C0332169
- UMLS CUI [2,2]
- C0087111
Description
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)?
Data type
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
Description
3. Does the patient have signs of secondary RLS (e.g. renal failure (end-stage renal disease), iron deficient anaemia or pregnancy at baseline)?
Data type
boolean
Alias
- UMLS CUI [1]
- C1536279
- UMLS CUI [2]
- C0035078
- UMLS CUI [3]
- C0022661
- UMLS CUI [4]
- C0162316
- UMLS CUI [5]
- C0032961
Description
4. Does the patient suffer from movement disorders (e.g. Parkinson’s disease, dyskinesias, and dystonias)?
Data type
boolean
Alias
- UMLS CUI [1]
- C0026650
- UMLS CUI [2]
- C0030567
- UMLS CUI [3]
- C0013384
- UMLS CUI [4]
- C0013421
Description
5. Pharmaceutical Preparations | Drowsiness | Restless Legs Syndrome | Sleep | Discontinuation (procedure); Baseline; Before
Data type
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
Description
6. Does the patient have diastolic blood pressure ≥110mmHg or ≤ 50mmHg OR systolic blood pressure ≥ 180mmHg or ≤ 90mmHg at baseline (Day 1 pre-dose)?
Data type
boolean
Alias
- UMLS CUI [1]
- C0428883
- UMLS CUI [2]
- C0871470
- UMLS CUI [3]
- C1442488
Description
7. Does the patient have a history or presence of symptomatic orthostatic hypotension?
Data type
boolean
Alias
- UMLS CUI [1]
- C0740482
Description
8. OTC - Over The Counter; Pharmaceutical Preparations | Before; Medication dose; First (number)
Data type
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
Description
9. Has the patient exhibited intolerance to ropinirole or any dopamine agonist?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1744706
- UMLS CUI [1,2]
- C0244821
- UMLS CUI [2]
- C0178601
Description
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
Data type
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
Description
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?
Data type
boolean
Alias
- UMLS CUI [1]
- C3831118
- UMLS CUI [2]
- C0240802
- UMLS CUI [3]
- C0006147
- UMLS CUI [4]
- C0220908
Description
12. DSM-IV; Alcohol abuse | DSM-IV; Drug abuse | Substance Dependence | alcohol units/day | alcohol units/week
Data type
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
Description
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
Data type
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
Description
14. Physical Examination; Abnormality | risk factors | Interferes with
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [2]
- C0035648
- UMLS CUI [3]
- C0521102
Description
15. Chemistry, Clinical; Hematologic Tests; Abnormality | Laboratory test finding; Normal Range | Age | risk factors
Data type
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
Description
16. 12 lead ECG; Abnormality | risk factors; Interferes with
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [2,1]
- C0035648
- UMLS CUI [2,2]
- C0521102
Description
17. Does the patient have a positive urine test for drugs of abuse at screening?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0202274
- UMLS CUI [1,2]
- C1446409
Description
18. Will the patient, in the opinion of the Investigator, be non-compliant with the visit schedule or other study procedures?
Data type
boolean
Alias
- UMLS CUI [1]
- C0457432
- UMLS CUI [2,1]
- C0545082
- UMLS CUI [2,2]
- C0086960
- UMLS CUI [3]
- C2700391
Description
19. Has the patient participated in a clinical trial with any drug within 3 months before the screening visit?
Data type
boolean
Alias
- UMLS CUI [1]
- C2348568
Description
20. Does the patient have positive hepatitis B surface antigen, hepatitis C antibodies and HIV - I/II antibody results at screening?
Data type
boolean
Alias
- UMLS CUI [1]
- C0019168
- UMLS CUI [2]
- C0166049
- UMLS CUI [3]
- C0019683
Description
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
Data type
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
Description
22. Is the patient taking fluctuating doses of oestrogen in both HRT or oral contraception?
Data type
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
Description
23. Will participation in this study result in the patient having donated more than 1500mL blood in the previous 12 months?
Data type
boolean
Alias
- UMLS CUI [1]
- C0005794
Description
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])