ID

26417

Description

Study Part: Pre-dose Checklist Week 3 PK Visit (Visit 8). 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

Keywords

Versions (1)
  1. 10/17/17 10/17/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 17, 2017

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
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.

Back to model comments
Itemgroup comments for :

Item comments for :

  • Newest
  • Oldest
  • Popular
  • Newest
    • Newest
    • Oldest
    • Popular

No comments

In order to download data models you must be logged in. Please log in or register for free.

Pre-dose Checklist Week 3 PK Visit (Visit 8) Ropinirole Parkinson Disease 101468/165

English

Pre-dose Checklist Week 3 PK Visit (Visit 8)

1 forms  
PREDOSE CHECKLIST
Description

PREDOSE CHECKLIST

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

Patient Number

Data type

text

Alias
UMLS CUI [1]
C1830427
Centre Number
Description

Centre Number

Data type

integer

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

Visit Date

Data type

date

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

alcohol consumption

Data type

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?
Description

xanthine-containing beverage and foods

Data type

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?
Description

poppy seed-containing food

Data type

boolean

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

smoking history

Data type

text

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

dosage

Data type

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?
Description

CYP1A2 inhibitors or inducers

Data type

text

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

Comments

Data type

text

Alias
UMLS CUI [1]
C0947611
Back to the top of the page

Similar models

Pre-dose Checklist Week 3 PK Visit (Visit 8)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial