ID

40467

Descrizione

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

versioni (1)
  1. 23/04/20 23/04/20 -
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GlaxoSmithKline

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23 aprile 2020

DOI

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Licenza

Creative Commons BY-NC 4.0
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Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/218

Inglese

Eligibility Criteria

1 moduli  
  1. StudyEvent: ODM
    1. Eligibility Criteria
Administrative
Descrizione

Administrative

Alias
UMLS CUI-1
C1320722
Patient Number
Descrizione

Patient Number

Tipo di dati

text

Alias
UMLS CUI [1]
C2348585
Centre Number
Descrizione

Centre Number

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Visit Date
Descrizione

Visit Date

Tipo di dati

date

Alias
UMLS CUI [1]
C1320303
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
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?
Descrizione

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 di dati

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0035258
UMLS CUI [3,1]
C2348561
UMLS CUI [3,2]
C0679228
UMLS CUI [4]
C0439603
2. Does the patient have a score of 15 or greater RLS Rating Scale at the baseline (Day 1) visit?
Descrizione

2. Does the patient have a score of 15 or greater RLS Rating Scale at the baseline (Day 1) visit?

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0681889
UMLS CUI [1,2]
C0035258
UMLS CUI [1,3]
C1442488
3. Is the patient aged between 18 and 79 years old, inclusive?
Descrizione

3. Is the patient aged between 18 and 79 years old, inclusive?

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0001779
4. Does the patient have a body mass index (BMI = weight kg/height m2) within the range 19 to 29 kg.m-2?
Descrizione

4. Does the patient have a body mass index (BMI = weight kg/height m2) within the range 19 to 29 kg.m-2?

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1305855
5. Has the patient given written informed consent prior to any specific study procedures being performed?
Descrizione

5. Has the patient given written informed consent prior to any specific study procedures being performed?

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0205369
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
1. Does the patient suffer from RLS symptoms which require treatment during the daytime (daytime defined as 10:00 until 18:00)?
Descrizione

1. Does the patient suffer from RLS symptoms which require treatment during the daytime (daytime defined as 10:00 until 18:00)?

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0035258
UMLS CUI [2,1]
C0332169
UMLS CUI [2,2]
C0087111
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)?
Descrizione

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 di dati

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
3. Does the patient have signs of secondary RLS (e.g. renal failure (end-stage renal disease), iron deficient anaemia or pregnancy at baseline)?
Descrizione

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 di dati

boolean

Alias
UMLS CUI [1]
C1536279
UMLS CUI [2]
C0035078
UMLS CUI [3]
C0022661
UMLS CUI [4]
C0162316
UMLS CUI [5]
C0032961
4. Does the patient suffer from movement disorders (e.g. Parkinson’s disease, dyskinesias, and dystonias)?
Descrizione

4. Does the patient suffer from movement disorders (e.g. Parkinson’s disease, dyskinesias, and dystonias)?

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0026650
UMLS CUI [2]
C0030567
UMLS CUI [3]
C0013384
UMLS CUI [4]
C0013421
5. Is the patient taking any medication known to induce drowsiness, affect RLS or sleep? (The minimum discontinuation period is 5 half lives or 5 consecutive nights medication free, prior to baseline, whichever is the longer period.)
Descrizione

5. Pharmaceutical Preparations | Drowsiness | Restless Legs Syndrome | Sleep | Discontinuation (procedure); Baseline; Before

Tipo di dati

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
6. Does the patient have diastolic blood pressure ≥110mmHg or ≤ 50mmHg OR systolic blood pressure ≥ 180mmHg or ≤ 90mmHg at baseline (Day 1 pre-dose)?
Descrizione

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 di dati

boolean

Alias
UMLS CUI [1]
C0428883
UMLS CUI [2]
C0871470
UMLS CUI [3]
C1442488
7. Does the patient have a history or presence of symptomatic orthostatic hypotension?
Descrizione

7. Does the patient have a history or presence of symptomatic orthostatic hypotension?

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0740482
8. Has the patient received over-the-counter (OTC) medicine within 48 hours before the first dose of study drug? (Patients who have taken OTC medication may still be entered in the study, if, in the opinion of the Investigator, the medication received will not interfere with the study procedures or compromise safety)
Descrizione

8. OTC - Over The Counter; Pharmaceutical Preparations | Before; Medication dose; First (number)

Tipo di dati

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
9. Has the patient exhibited intolerance to ropinirole or any dopamine agonist?
Descrizione

9. Has the patient exhibited intolerance to ropinirole or any dopamine agonist?

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0244821
UMLS CUI [2]
C0178601
10. Is the patient a women of child-bearing potential who is not practising a clinically accepted method of contraception such as oral contraception, surgical sterilisation, I.U.D., diaphragm in conjunction with spermicidal foam and condom on the male partner, or systemic contraception (i.e., Norplant)?
Descrizione

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 di dati

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
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?
Descrizione

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 di dati

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2]
C0240802
UMLS CUI [3]
C0006147
UMLS CUI [4]
C0220908
12. Does the patient meet DSM-IV criteria for substance ’abuse’ (alcohol or drugs) or substance ’dependence’ within 6 months prior to screening? (abuse of alcohol defined as an intake of grater than 3 units per day or 21 units per week for male or 2 units per day or 14 units per week for females. (one unit is equivalent to half pint of beer, one measure of sprits or one small glass of wine)
Descrizione

12. DSM-IV; Alcohol abuse | DSM-IV; Drug abuse | Substance Dependence | alcohol units/day | alcohol units/week

Tipo di dati

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
13. Does the patient have a history or presence of gastro-intestinal, hepatic or renal disease or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs?
Descrizione

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 di dati

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
14. Does the patients have an abnormality on physical examination? A patient with a clinical abnormality may be included only if the Investigator considers that the abnormality will not introduce additional risk factors and will not interfere with the study procedure.
Descrizione

14. Physical Examination; Abnormality | risk factors | Interferes with

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C1704258
UMLS CUI [2]
C0035648
UMLS CUI [3]
C0521102
15. Does the patient have an abnormality on clinical chemistry of haematology examination at screening? (Patients with laboratory parameters outside the reference range for this age group will only be included if the Investigator considers that such findings will not introduce additional risk factors)
Descrizione

15. Chemistry, Clinical; Hematologic Tests; Abnormality | Laboratory test finding; Normal Range | Age | risk factors

Tipo di dati

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
16. Does the patient have an abnormal 12 lead ECG at the screening visit? A patient with an abdominal ECG trace may be included only if the Investigator considers that the abnormality will not introduce additional risks factors and will not interfere with study procedures.
Descrizione

16. 12 lead ECG; Abnormality | risk factors; Interferes with

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [2,1]
C0035648
UMLS CUI [2,2]
C0521102
17. Does the patient have a positive urine test for drugs of abuse at screening?
Descrizione

17. Does the patient have a positive urine test for drugs of abuse at screening?

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C1446409
18. Will the patient, in the opinion of the Investigator, be non-compliant with the visit schedule or other study procedures?
Descrizione

18. Will the patient, in the opinion of the Investigator, be non-compliant with the visit schedule or other study procedures?

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0457432
UMLS CUI [2,1]
C0545082
UMLS CUI [2,2]
C0086960
UMLS CUI [3]
C2700391
19. Has the patient participated in a clinical trial with any drug within 3 months before the screening visit?
Descrizione

19. Has the patient participated in a clinical trial with any drug within 3 months before the screening visit?

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2348568
20. Does the patient have positive hepatitis B surface antigen, hepatitis C antibodies and HIV - I/II antibody results at screening?
Descrizione

20. Does the patient have positive hepatitis B surface antigen, hepatitis C antibodies and HIV - I/II antibody results at screening?

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0019168
UMLS CUI [2]
C0166049
UMLS CUI [3]
C0019683
21. Has there been a withdrawal, introduction or change in dose hormone replacement therapy (HRT) and/or any drug known to substantiality inhibit or induce CYPIA2 within 7 days prior to first dose?
Descrizione

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 di dati

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
22. Is the patient taking fluctuating doses of oestrogen in both HRT or oral contraception?
Descrizione

22. Is the patient taking fluctuating doses of oestrogen in both HRT or oral contraception?

Tipo di dati

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
23. Will participation in this study result in the patient having donated more than 1500mL blood in the previous 12 months?
Descrizione

23. Will participation in this study result in the patient having donated more than 1500mL blood in the previous 12 months?

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0005794
Investigator's Signature
Descrizione

Investigator's Signature

Alias
UMLS CUI-1
C2346576
Investigator's Signature
Descrizione

Investigator's Signature

Tipo di dati

text

Alias
UMLS CUI [1]
C2346576
Investigator's Signature Date
Descrizione

Investigator's Signature Date

Tipo di dati

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Similar models

Eligibility Criteria

1 moduli
  1. StudyEvent: ODM
    1. Eligibility Criteria
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Patient Number
Item
Patient Number
text
C2348585 (UMLS CUI [1])
Centre Number
Item
Centre Number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
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?
Item
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?
boolean
C0079399 (UMLS CUI [1])
C0035258 (UMLS CUI [2])
C2348561 (UMLS CUI [3,1])
C0679228 (UMLS CUI [3,2])
C0439603 (UMLS CUI [4])
2. Does the patient have a score of 15 or greater RLS Rating Scale at the baseline (Day 1) visit?
Item
2. Does the patient have a score of 15 or greater RLS Rating Scale at the baseline (Day 1) visit?
boolean
C0681889 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
C1442488 (UMLS CUI [1,3])
3. Is the patient aged between 18 and 79 years old, inclusive?
Item
3. Is the patient aged between 18 and 79 years old, inclusive?
boolean
C0001779 (UMLS CUI [1])
4. Does the patient have a body mass index (BMI = weight kg/height m2) within the range 19 to 29 kg.m-2?
Item
4. Does the patient have a body mass index (BMI = weight kg/height m2) within the range 19 to 29 kg.m-2?
boolean
C1305855 (UMLS CUI [1])
5. Has the patient given written informed consent prior to any specific study procedures being performed?
Item
5. Has the patient given written informed consent prior to any specific study procedures being performed?
boolean
C0021430 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0205369 (UMLS CUI [2,2])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
1. Does the patient suffer from RLS symptoms which require treatment during the daytime (daytime defined as 10:00 until 18:00)?
Item
1. Does the patient suffer from RLS symptoms which require treatment during the daytime (daytime defined as 10:00 until 18:00)?
boolean
C1457887 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
C0332169 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
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)?
Item
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)?
boolean
C0236991 (UMLS CUI [1])
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])
3. Does the patient have signs of secondary RLS (e.g. renal failure (end-stage renal disease), iron deficient anaemia or pregnancy at baseline)?
Item
3. Does the patient have signs of secondary RLS (e.g. renal failure (end-stage renal disease), iron deficient anaemia or pregnancy at baseline)?
boolean
C1536279 (UMLS CUI [1])
C0035078 (UMLS CUI [2])
C0022661 (UMLS CUI [3])
C0162316 (UMLS CUI [4])
C0032961 (UMLS CUI [5])
4. Does the patient suffer from movement disorders (e.g. Parkinson’s disease, dyskinesias, and dystonias)?
Item
4. Does the patient suffer from movement disorders (e.g. Parkinson’s disease, dyskinesias, and dystonias)?
boolean
C0026650 (UMLS CUI [1])
C0030567 (UMLS CUI [2])
C0013384 (UMLS CUI [3])
C0013421 (UMLS CUI [4])
5. Pharmaceutical Preparations | Drowsiness | Restless Legs Syndrome | Sleep | Discontinuation (procedure); Baseline; Before
Item
5. Is the patient taking any medication known to induce drowsiness, affect RLS or sleep? (The minimum discontinuation period is 5 half lives or 5 consecutive nights medication free, prior to baseline, whichever is the longer period.)
boolean
C0013227 (UMLS CUI [1])
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])
6. Does the patient have diastolic blood pressure ≥110mmHg or ≤ 50mmHg OR systolic blood pressure ≥ 180mmHg or ≤ 90mmHg at baseline (Day 1 pre-dose)?
Item
6. Does the patient have diastolic blood pressure ≥110mmHg or ≤ 50mmHg OR systolic blood pressure ≥ 180mmHg or ≤ 90mmHg at baseline (Day 1 pre-dose)?
boolean
C0428883 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C1442488 (UMLS CUI [3])
7. Does the patient have a history or presence of symptomatic orthostatic hypotension?
Item
7. Does the patient have a history or presence of symptomatic orthostatic hypotension?
boolean
C0740482 (UMLS CUI [1])
8. OTC - Over The Counter; Pharmaceutical Preparations | Before; Medication dose; First (number)
Item
8. Has the patient received over-the-counter (OTC) medicine within 48 hours before the first dose of study drug? (Patients who have taken OTC medication may still be entered in the study, if, in the opinion of the Investigator, the medication received will not interfere with the study procedures or compromise safety)
boolean
C2709201 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0332152 (UMLS CUI [2,1])
C3174092 (UMLS CUI [2,2])
C0205435 (UMLS CUI [2,3])
9. Has the patient exhibited intolerance to ropinirole or any dopamine agonist?
Item
9. Has the patient exhibited intolerance to ropinirole or any dopamine agonist?
boolean
C1744706 (UMLS CUI [1,1])
C0244821 (UMLS CUI [1,2])
C0178601 (UMLS CUI [2])
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
Item
10. Is the patient a women of child-bearing potential who is not practising a clinically accepted method of contraception such as oral contraception, surgical sterilisation, I.U.D., diaphragm in conjunction with spermicidal foam and condom on the male partner, or systemic contraception (i.e., Norplant)?
boolean
C3831118 (UMLS CUI [1])
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])
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?
Item
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?
boolean
C3831118 (UMLS CUI [1])
C0240802 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C0220908 (UMLS CUI [4])
12. DSM-IV; Alcohol abuse | DSM-IV; Drug abuse | Substance Dependence | alcohol units/day | alcohol units/week
Item
12. Does the patient meet DSM-IV criteria for substance ’abuse’ (alcohol or drugs) or substance ’dependence’ within 6 months prior to screening? (abuse of alcohol defined as an intake of grater than 3 units per day or 21 units per week for male or 2 units per day or 14 units per week for females. (one unit is equivalent to half pint of beer, one measure of sprits or one small glass of wine)
boolean
C0220952 (UMLS CUI [1,1])
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])
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
Item
13. Does the patient have a history or presence of gastro-intestinal, hepatic or renal disease or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs?
boolean
C0017178 (UMLS CUI [1])
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])
14. Physical Examination; Abnormality | risk factors | Interferes with
Item
14. Does the patients have an abnormality on physical examination? A patient with a clinical abnormality may be included only if the Investigator considers that the abnormality will not introduce additional risk factors and will not interfere with the study procedure.
boolean
C0031809 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0035648 (UMLS CUI [2])
C0521102 (UMLS CUI [3])
15. Chemistry, Clinical; Hematologic Tests; Abnormality | Laboratory test finding; Normal Range | Age | risk factors
Item
15. Does the patient have an abnormality on clinical chemistry of haematology examination at screening? (Patients with laboratory parameters outside the reference range for this age group will only be included if the Investigator considers that such findings will not introduce additional risk factors)
boolean
C0008000 (UMLS CUI [1,1])
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])
16. 12 lead ECG; Abnormality | risk factors; Interferes with
Item
16. Does the patient have an abnormal 12 lead ECG at the screening visit? A patient with an abdominal ECG trace may be included only if the Investigator considers that the abnormality will not introduce additional risks factors and will not interfere with study procedures.
boolean
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0035648 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
17. Does the patient have a positive urine test for drugs of abuse at screening?
Item
17. Does the patient have a positive urine test for drugs of abuse at screening?
boolean
C0202274 (UMLS CUI [1,1])
C1446409 (UMLS CUI [1,2])
18. Will the patient, in the opinion of the Investigator, be non-compliant with the visit schedule or other study procedures?
Item
18. Will the patient, in the opinion of the Investigator, be non-compliant with the visit schedule or other study procedures?
boolean
C0457432 (UMLS CUI [1])
C0545082 (UMLS CUI [2,1])
C0086960 (UMLS CUI [2,2])
C2700391 (UMLS CUI [3])
19. Has the patient participated in a clinical trial with any drug within 3 months before the screening visit?
Item
19. Has the patient participated in a clinical trial with any drug within 3 months before the screening visit?
boolean
C2348568 (UMLS CUI [1])
20. Does the patient have positive hepatitis B surface antigen, hepatitis C antibodies and HIV - I/II antibody results at screening?
Item
20. Does the patient have positive hepatitis B surface antigen, hepatitis C antibodies and HIV - I/II antibody results at screening?
boolean
C0019168 (UMLS CUI [1])
C0166049 (UMLS CUI [2])
C0019683 (UMLS CUI [3])
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
Item
21. Has there been a withdrawal, introduction or change in dose hormone replacement therapy (HRT) and/or any drug known to substantiality inhibit or induce CYPIA2 within 7 days prior to first dose?
boolean
C2349954 (UMLS CUI [1])
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])
22. Is the patient taking fluctuating doses of oestrogen in both HRT or oral contraception?
Item
22. Is the patient taking fluctuating doses of oestrogen in both HRT or oral contraception?
boolean
C0279494 (UMLS CUI [1,1])
C0678766 (UMLS CUI [1,2])
C0231241 (UMLS CUI [1,3])
C0282402 (UMLS CUI [2])
C0029151 (UMLS CUI [3])
23. Will participation in this study result in the patient having donated more than 1500mL blood in the previous 12 months?
Item
23. Will participation in this study result in the patient having donated more than 1500mL blood in the previous 12 months?
boolean
C0005794 (UMLS CUI [1])
Item Group
Investigator's Signature
C2346576 (UMLS CUI-1)
Investigator's Signature
Item
Investigator's Signature
text
C2346576 (UMLS CUI [1])
Investigator's Signature Date
Item
Investigator's Signature Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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