ID

40499

Descrição

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

Palavras-chave

Versões (4)
  1. 27/04/2020 27/04/2020 -
  2. 04/05/2020 04/05/2020 -
  3. 08/05/2020 08/05/2020 -
  4. 08/05/2020 08/05/2020 -
Titular dos direitos

GlaxoSmithKline

Transferido a

27 de abril de 2020

DOI

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Licença

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

Inglês

Dose Level 1, Day1 - Predose Checklist

1 Formulários  
Administrative
Descrição

Administrative

Alias
UMLS CUI-1
C1320722
Patient Number
Descrição

Patient Number

Tipo de dados

text

Alias
UMLS CUI [1]
C2348585
Centre Number
Descrição

Centre Number

Tipo de dados

text

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

Visit Date

Tipo de dados

date

Alias
UMLS CUI [1]
C1320303
Predose Checklist
Descrição

Predose Checklist

Alias
UMLS CUI-1
C0439565
UMLS CUI-2
C1707357
1. Has the patient washed out from their previous RLS medication for the appropiate length of time? (DAY 1)
Descrição

1. Has the patient washed out from their previous RLS medication for the appropiate length of time? (DAY 1)

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1710661
UMLS CUI [2,1]
C0013216
UMLS CUI [2,2]
C0035258
UMLS CUI [2,3]
C0205156
UMLS CUI [3]
C0449238
2. Has the patient refrained from consuming alcohol for 24 hours prior to the clinic visit?
Descrição

2. Has the patient refrained from consuming alcohol for 24 hours prior to the clinic visit?

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C1517741
3. Has the patient limited their daily alcohol consumption to no more than 3 units for men and 2 units for women? (1 unit is equivalent to 1 beer, one measure of sprits or 1 small glass of wine.)
Descrição

3. Has the patient limited their daily alcohol consumption to no more than 3 units for men and 2 units for women? (1 unit is equivalent to 1 beer, one measure of sprits or 1 small glass of wine.)

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0443288
UMLS CUI [2]
C0560579
UMLS CUI [3]
C0559430
UMLS CUI [4]
C0043188
4. Has the patient refrained from strenuous exercise (outside of normal routine) from 48 hours before the clinic visit?
Descrição

4. Has the patient refrained from strenuous exercise (outside of normal routine) from 48 hours before the clinic visit?

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1514989
UMLS CUI [1,2]
C0443288
UMLS CUI [2,1]
C0008952
UMLS CUI [2,2]
C0332152
5. Has the patient maintained their normal smoking practice?
Descrição

5. Has the patient maintained their normal smoking practice?

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1519386
6. Has the patient refrained from fluctuating dose of oestrogen ie. in hormone replacement therapy (HRT) or oral contraceptives?
Descrição

6. Has the patient refrained from fluctuating dose of oestrogen ie. in hormone replacement therapy (HRT) or oral contraceptives?

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0279494
UMLS CUI [1,2]
C0678766
UMLS CUI [1,3]
C0231241
UMLS CUI [1,4]
C0282402
UMLS CUI [2]
C0029151
7. Has the patient refrained from taking other medication (OTC or herbal remedies) for 48 hours prior to the clinic visit? Patients who have taken OTC medication may still be able to continue in the study, if, in the opinion of the Investigator, the medication received will not interfere with the study procedures or compromise safety.
Descrição

7. Taking medication (activity); Other; Restricted | OTC - Over The Counter | Medicinal Herbs | Clinic Visits; Before | Interferes with; Procedure (set of actions); Clinical Research

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1290952
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0443288
UMLS CUI [2]
C2709201
UMLS CUI [3]
C0025125
UMLS CUI [4,1]
C0008952
UMLS CUI [4,2]
C0332152
UMLS CUI [5,1]
C0521102
UMLS CUI [5,2]
C2700391
UMLS CUI [5,3]
C0008972
8. Has the patient washed out from any previous prohibited medication for the appropriate length of time?
Descrição

8. Has the patient washed out from any previous prohibited medication for the appropriate length of time?

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1710661
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0683610
UMLS CUI [1,4]
C0205156
UMLS CUI [2]
C0449238
9. For the concomitant medications which are CYP1A2 inducers, substrates or inhibitors, has the patient kept the dose constant? (this includes women taking hormone replacement therapy (HRT) or oestrogen containing medications)
Descrição

9. Concomitant Agent; Drug induction of cytochrome p450 CYP1A2 enzyme | Cytochrome P-450 CYP1A2; enzyme substrate | C1827504 Drug inhibition of cytochrome p450 CYP1A2 enzyme | Dosage; Constant (qualifier) | Hormone replacement therapy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1827490
UMLS CUI [2,1]
C0207509
UMLS CUI [2,2]
C0178623
UMLS CUI [3]
C1827504
UMLS CUI [4,1]
C0178602
UMLS CUI [4,2]
C1948059
UMLS CUI [5]
C0282402
10. Has the patient completed 2 consecutive nights of baseline actigraphy and ambulatory sleep EEG recordings at home?
Descrição

10. Has the patient completed 2 consecutive nights of baseline actigraphy and ambulatory sleep EEG recordings at home?

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1442488
UMLS CUI [2,1]
C1171301
UMLS CUI [2,2]
C0013819
UMLS CUI [2,3]
C0037313
UMLS CUI [3,1]
C0013819
UMLS CUI [3,2]
C0037313
UMLS CUI [3,3]
C0439841
11. Has the patient completed the St Mary’s Sleep Questionnaire at home?
Descrição

11. Has the patient completed the St Mary’s Sleep Questionnaire at home?

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0034394
UMLS CUI [1,2]
C0037313
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Similar models

Dose Level 1, Day1 - Predose Checklist

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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
Predose Checklist
C0439565 (UMLS CUI-1)
C1707357 (UMLS CUI-2)
1. Has the patient washed out from their previous RLS medication for the appropiate length of time? (DAY 1)
Item
1. Has the patient washed out from their previous RLS medication for the appropiate length of time? (DAY 1)
boolean
C1710661 (UMLS CUI [1])
C0013216 (UMLS CUI [2,1])
C0035258 (UMLS CUI [2,2])
C0205156 (UMLS CUI [2,3])
C0449238 (UMLS CUI [3])
2. Has the patient refrained from consuming alcohol for 24 hours prior to the clinic visit?
Item
2. Has the patient refrained from consuming alcohol for 24 hours prior to the clinic visit?
boolean
C0001948 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
3. Has the patient limited their daily alcohol consumption to no more than 3 units for men and 2 units for women? (1 unit is equivalent to 1 beer, one measure of sprits or 1 small glass of wine.)
Item
3. Has the patient limited their daily alcohol consumption to no more than 3 units for men and 2 units for women? (1 unit is equivalent to 1 beer, one measure of sprits or 1 small glass of wine.)
boolean
C0001948 (UMLS CUI [1,1])
C0443288 (UMLS CUI [1,2])
C0560579 (UMLS CUI [2])
C0559430 (UMLS CUI [3])
C0043188 (UMLS CUI [4])
4. Has the patient refrained from strenuous exercise (outside of normal routine) from 48 hours before the clinic visit?
Item
4. Has the patient refrained from strenuous exercise (outside of normal routine) from 48 hours before the clinic visit?
boolean
C1514989 (UMLS CUI [1,1])
C0443288 (UMLS CUI [1,2])
C0008952 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
5. Has the patient maintained their normal smoking practice?
Item
5. Has the patient maintained their normal smoking practice?
boolean
C1519386 (UMLS CUI [1])
6. Has the patient refrained from fluctuating dose of oestrogen ie. in hormone replacement therapy (HRT) or oral contraceptives?
Item
6. Has the patient refrained from fluctuating dose of oestrogen ie. in hormone replacement therapy (HRT) or oral contraceptives?
boolean
C0279494 (UMLS CUI [1,1])
C0678766 (UMLS CUI [1,2])
C0231241 (UMLS CUI [1,3])
C0282402 (UMLS CUI [1,4])
C0029151 (UMLS CUI [2])
7. Taking medication (activity); Other; Restricted | OTC - Over The Counter | Medicinal Herbs | Clinic Visits; Before | Interferes with; Procedure (set of actions); Clinical Research
Item
7. Has the patient refrained from taking other medication (OTC or herbal remedies) for 48 hours prior to the clinic visit? Patients who have taken OTC medication may still be able to continue in the study, if, in the opinion of the Investigator, the medication received will not interfere with the study procedures or compromise safety.
boolean
C1290952 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0443288 (UMLS CUI [1,3])
C2709201 (UMLS CUI [2])
C0025125 (UMLS CUI [3])
C0008952 (UMLS CUI [4,1])
C0332152 (UMLS CUI [4,2])
C0521102 (UMLS CUI [5,1])
C2700391 (UMLS CUI [5,2])
C0008972 (UMLS CUI [5,3])
8. Has the patient washed out from any previous prohibited medication for the appropriate length of time?
Item
8. Has the patient washed out from any previous prohibited medication for the appropriate length of time?
boolean
C1710661 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0683610 (UMLS CUI [1,3])
C0205156 (UMLS CUI [1,4])
C0449238 (UMLS CUI [2])
9. Concomitant Agent; Drug induction of cytochrome p450 CYP1A2 enzyme | Cytochrome P-450 CYP1A2; enzyme substrate | C1827504 Drug inhibition of cytochrome p450 CYP1A2 enzyme | Dosage; Constant (qualifier) | Hormone replacement therapy
Item
9. For the concomitant medications which are CYP1A2 inducers, substrates or inhibitors, has the patient kept the dose constant? (this includes women taking hormone replacement therapy (HRT) or oestrogen containing medications)
boolean
C2347852 (UMLS CUI [1,1])
C1827490 (UMLS CUI [1,2])
C0207509 (UMLS CUI [2,1])
C0178623 (UMLS CUI [2,2])
C1827504 (UMLS CUI [3])
C0178602 (UMLS CUI [4,1])
C1948059 (UMLS CUI [4,2])
C0282402 (UMLS CUI [5])
10. Has the patient completed 2 consecutive nights of baseline actigraphy and ambulatory sleep EEG recordings at home?
Item
10. Has the patient completed 2 consecutive nights of baseline actigraphy and ambulatory sleep EEG recordings at home?
boolean
C1442488 (UMLS CUI [1])
C1171301 (UMLS CUI [2,1])
C0013819 (UMLS CUI [2,2])
C0037313 (UMLS CUI [2,3])
C0013819 (UMLS CUI [3,1])
C0037313 (UMLS CUI [3,2])
C0439841 (UMLS CUI [3,3])
11. Has the patient completed the St Mary’s Sleep Questionnaire at home?
Item
11. Has the patient completed the St Mary’s Sleep Questionnaire at home?
boolean
C0034394 (UMLS CUI [1,1])
C0037313 (UMLS CUI [1,2])
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