ID

26748

Beskrivning

Study Part: Pre-dose Checklist Week 5 PK Visit (Visit 9). An open-label, up-titration study to assess the dose proportionality of ropinirole controlled release (CR) and to demonstrate the bioequivalence of ropinirole CR (1 x 8 mg) compared to the ropinirole CR (4 x 2 mg) in Parkinson's Disease patients not receiving other dopaminergic therapies. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Phase: phase 2. Study Recruitment Status: Completed. Generic Name: ropinirole. Trade Name: Modutab, ZIPEREVE, ZEPREVE, REPREVE, ADARTREL, REQUIP,Zygara. Study Indication: Parkinson Disease. Study ID: 101468/165. Clinical Study ID: 101468/165

Nyckelord

Versioner (1)
  1. 2017-10-23 2017-10-23 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

23 oktober 2017

DOI

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Licens

Creative Commons BY-NC 3.0
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Pre-dose Checklist Week 5 PK Visit (Visit 9) Ropinirole Parkinson Disease 101468/165

Engelsk

Pre-dose Checklist Week 5 PK Visit (Visit 9)

1 Formulär  
PREDOSE CHECKLIST
Beskrivning

PREDOSE CHECKLIST

Alias
UMLS CUI-1
C0439565
UMLS CUI-2
C1707357
Patient Number
Beskrivning

Patient Number

Datatyp

text

Alias
UMLS CUI [1]
C1830427
Centre Number
Beskrivning

Centre Number

Datatyp

integer

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

Visit Date

Datatyp

date

Alias
UMLS CUI [1]
C1320303
1. Has the patient refrained from consuming alcohol for 24 hours prior to the clinic visit?
Beskrivning

alcohol consumption

Datatyp

boolean

Alias
UMLS CUI [1]
C0001948
2. Has the patient tried to refrain from consuming xanthine-containing beverage and foods (coffee, tea, cola beverages, cocoa, chocolate), grapefruit-containing products, quinine-containing products and food containing CYP1A2-inducing constituents (broccoli, bussels sprouts, cabbage etc.) within 24 hours of the clinic visit?
Beskrivning

xanthine-containing beverage and foods

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0043314
UMLS CUI [1,2]
C0016452
3. Has the patient refrained from consuming poppy seed-containing food (e.g. poppy cake) for three days before the clinic visit?
Beskrivning

poppy seed-containing food

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0453264
UMLS CUI [1,2]
C0016452
4. Has the patient maintained their normal smoking practice?
Beskrivning

smoking history

Datatyp

text

Alias
UMLS CUI [1]
C1519384
5. Has the subject had at least 3 sequential days of dosing?
Beskrivning

dosage

Datatyp

text

Alias
UMLS CUI [1]
C0178602
6. If the patient is already taking a drug known to substantially inhibit CYP1A2 or induce CYP1A2, has the patient remained on stable doses of the agent from 7 days prior to dosing with study medication?
Beskrivning

CYP1A2 inhibitors or inducers

Datatyp

text

Alias
UMLS CUI [1,1]
C1827504
UMLS CUI [1,2]
C1827490
Comments:
Beskrivning

Comments

Datatyp

text

Alias
UMLS CUI [1]
C0947611
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Similar models

Pre-dose Checklist Week 5 PK Visit (Visit 9)

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
PREDOSE CHECKLIST
C0439565 (UMLS CUI-1)
C1707357 (UMLS CUI-2)
Patient Number
Item
Patient Number
text
C1830427 (UMLS CUI [1])
Centre Number
Item
Centre Number
integer
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
alcohol consumption
Item
1. Has the patient refrained from consuming alcohol for 24 hours prior to the clinic visit?
boolean
C0001948 (UMLS CUI [1])
xanthine-containing beverage and foods
Item
2. Has the patient tried to refrain from consuming xanthine-containing beverage and foods (coffee, tea, cola beverages, cocoa, chocolate), grapefruit-containing products, quinine-containing products and food containing CYP1A2-inducing constituents (broccoli, bussels sprouts, cabbage etc.) within 24 hours of the clinic visit?
boolean
C0043314 (UMLS CUI [1,1])
C0016452 (UMLS CUI [1,2])
poppy seed-containing food
Item
3. Has the patient refrained from consuming poppy seed-containing food (e.g. poppy cake) for three days before the clinic visit?
boolean
C0453264 (UMLS CUI [1,1])
C0016452 (UMLS CUI [1,2])
Item
4. Has the patient maintained their normal smoking practice?
text
C1519384 (UMLS CUI [1])
smoking history
Code List
4. Has the patient maintained their normal smoking practice?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
N/A (N/A)
Item
5. Has the subject had at least 3 sequential days of dosing?
text
C0178602 (UMLS CUI [1])
smoking history
Code List
5. Has the subject had at least 3 sequential days of dosing?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
N/A (N/A)
Item
6. If the patient is already taking a drug known to substantially inhibit CYP1A2 or induce CYP1A2, has the patient remained on stable doses of the agent from 7 days prior to dosing with study medication?
text
C1827504 (UMLS CUI [1,1])
C1827490 (UMLS CUI [1,2])
smoking history
Code List
6. If the patient is already taking a drug known to substantially inhibit CYP1A2 or induce CYP1A2, has the patient remained on stable doses of the agent from 7 days prior to dosing with study medication?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
N/A (N/A)
Comments
Item
Comments:
text
C0947611 (UMLS CUI [1])
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