ID

25986

Beskrivning

Study Drug Dosing - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164 Study ID: 101468/164 Clinical Study ID: 101468/164 Study Title: An open-label, randomised, two part study to investigate the relative bioavailability of Ropinirole new and standard, marketed formulations and the effect of food on the pharmacokinetics of Ropinirole new formulation in early stage Parkinson’s disease subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL

Nyckelord

Versioner (1)
  1. 2017-10-03 2017-10-03 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

3 oktober 2017

DOI

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Creative Commons BY-NC 3.0
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Study Drug Dosing - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

Engelsk

Study Drug Dosing - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

1 Formulär  
Preliminary note
Beskrivning

Preliminary note

Alias
UMLS CUI-1
C1548998
Is the subject receiving a daily dose of 8 mg ropinirole CR ?
Beskrivning

If 'yes', proceed on page 32.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0244821
UMLS CUI [1,2]
C2348070
If NO: Is the subject receiving a daily dose > 8 mg ropinirole CR ?
Beskrivning

If 'yes', proceed on page 31. If NO: The subject has to be titrated up to a daily dose of 8 mg ropinirole CR. Proceed on page 16.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0244821
UMLS CUI [1,2]
C2348070
Patient diary
Beskrivning

Patient diary

Alias
UMLS CUI-1
C3890583
Patient diary
Beskrivning

Please dispense the Patient Diary and give instructions for completion. Please inform the subject that he/she should bring back the diary at each clinic visit. Please remind the subject that he/she must refrain from alcohol consumption for 24 hours prior to and throughout Part A of the study. Subjects will be encouraged to refrain from consuming xanthine-containing beverages and foods (coffee, tea, cola beverages, cocoa, chocolate), grapefruit-containing products, quinine-containing products and food containing CYP1A2-inducing constituents (broccoli, brussel sprouts, cabbage, etc ) from 24 hours prior to PK evaluation days in Part A, periods 1 and 2 and from 24 hours before each PK evaluation day in Part B.

Datatyp

text

Alias
UMLS CUI [1]
C3890583
Pregnancy test
Beskrivning

Pregnancy test

Alias
UMLS CUI-1
C0032976
Was a pregnancy test performed?
Beskrivning

pregnancy test

Datatyp

integer

Alias
UMLS CUI [1]
C0032976
If yes, what type of pregnancy test was performed?
Beskrivning

type of pregnancy test

Datatyp

integer

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0332307
If Yes, Date of Test
Beskrivning

Date of pregnancy test

Datatyp

date

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0011008
Result
Beskrivning

Result of pregnancy test

Datatyp

integer

Alias
UMLS CUI [1]
C0427777
Orthostatic blood pressure / Pulse measurement - Predose
Beskrivning

Orthostatic blood pressure / Pulse measurement - Predose

Alias
UMLS CUI-1
C1095971
UMLS CUI-2
C0232117
UMLS CUI-3
C3812758
Time point
Beskrivning

Date of visit

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Heart Rate semi-supine
Beskrivning

Heart rate Semi-Supine

Datatyp

integer

Måttenheter
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0038846
bpm
Heart Rate standing
Beskrivning

Heart Rate standing

Datatyp

integer

Måttenheter
  • bpm
Alias
UMLS CUI [1]
C2029905
bpm
Systolic blood pressure semi-supine
Beskrivning

Systolic blood pressure semi-supine

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0038846
mmHg
Diastolic blood pressure semi-supine
Beskrivning

Diastolic blood pressure semi-supine

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0038846
mmHg
Systolic blood pressure standing
Beskrivning

Systolic blood pressure standing

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0231472
mmHg
Diastolic blood pressure standing
Beskrivning

Diastolic blood pressure standing

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0231472
mmHg
Concomitant medication
Beskrivning

Concomitant medication

Alias
UMLS CUI-1
C2347852
Has the subject had any changes in medication since the last study visit?
Beskrivning

If 'Yes', please document on the Concomitant Medication Report Forms.

Datatyp

integer

Alias
UMLS CUI [1]
C0580105
Have the subject's smoking habits remained unchanged?
Beskrivning

tobacco use unchanged

Datatyp

integer

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C0442739
Adverse event
Beskrivning

Adverse event

Alias
UMLS CUI-1
C0877248
Has the subject experienced any Adverse Events since the previous clinic visit?
Beskrivning

If 'Yes', please document on the Adverse Event Report Forms.

Datatyp

integer

Alias
UMLS CUI [1]
C0877248
Study Drug Dosing
Beskrivning

Study Drug Dosing

Alias
UMLS CUI-1
C0013175
UMLS CUI-2
C0678766
Enter the dose of study drug prescribed at this visit
Beskrivning

study drug dose

Datatyp

float

Måttenheter
  • mg/day
Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0013175
UMLS CUI [1,3]
C0178602
mg/day
Time of first dose
Beskrivning

Time of first dose

Datatyp

time

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0205435
UMLS CUI [1,3]
C0040223
Witness 1
Beskrivning

Witness 1

Datatyp

text

Alias
UMLS CUI [1,1]
C0682356
UMLS CUI [1,2]
C0001555
Witness 2
Beskrivning

Witness 2

Datatyp

text

Alias
UMLS CUI [1,1]
C0682356
UMLS CUI [1,2]
C0001555
Witness date
Beskrivning

Witness date

Datatyp

date

Alias
UMLS CUI [1,1]
C4263486
UMLS CUI [1,2]
C0011008
Orthostatic blood pressure / pulse measurement - post dose
Beskrivning

Orthostatic blood pressure / pulse measurement - post dose

Alias
UMLS CUI-1
C1095971
UMLS CUI-2
C0232117
UMLS CUI-3
C0439568
Time point
Beskrivning

Date of visit

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Post Dose
Beskrivning

Post dose

Datatyp

integer

Alias
UMLS CUI [1]
C0439568
Time of post dose
Beskrivning

Time post dose

Datatyp

time

Alias
UMLS CUI [1,1]
C0439568
UMLS CUI [1,2]
C0040223
Heart Rate semi-supine
Beskrivning

Heart rate Semi-Supine

Datatyp

integer

Måttenheter
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0038846
bpm
Heart Rate standing
Beskrivning

Heart Rate standing

Datatyp

integer

Måttenheter
  • bpm
Alias
UMLS CUI [1]
C2029905
bpm
Systolic blood pressure semi-supine
Beskrivning

Systolic blood pressure semi-supine

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0038846
mmHg
Diastolic blood pressure semi-supine
Beskrivning

Diastolic blood pressure semi-supine

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0038846
mmHg
Systolic blood pressure standing
Beskrivning

Systolic blood pressure standing

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0231472
mmHg
Diastolic blood pressure standing
Beskrivning

Diastolic blood pressure standing

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0231472
mmHg
Adverse Event - 4 hours post dosing
Beskrivning

Adverse Event - 4 hours post dosing

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C0439574
Has the subject experienced any Adverse Events since the time of dosing?
Beskrivning

If Yes , please document on the Adverse Event Report Forms

Datatyp

integer

Alias
UMLS CUI [1]
C0877248
Discharge
Beskrivning

Discharge

Alias
UMLS CUI-1
C0030685
Time of discharge from study site:
Beskrivning

Discharge Time

Datatyp

time

Alias
UMLS CUI [1]
C3864299
Date of next study visit
Beskrivning

Date of next study visit

Datatyp

date

Alias
UMLS CUI [1]
C1545257
Telephone call
Beskrivning

Telephone call

Alias
UMLS CUI-1
C0302186
Was a phone call made to the patient 72 hours after Titration Visit?
Beskrivning

Phone call with patient

Datatyp

integer

Alias
UMLS CUI [1]
C0199339
Date of call
Beskrivning

Date of call

Datatyp

date

Alias
UMLS CUI [1,1]
C0302186
UMLS CUI [1,2]
C0011008
Time of call
Beskrivning

Time of call

Datatyp

time

Alias
UMLS CUI [1,1]
C0302186
UMLS CUI [1,2]
C0040223
Adverse events
Beskrivning

Adverse events

Alias
UMLS CUI-1
C0877248
Has the subject experienced any Adverse Events since discharge from the study site?
Beskrivning

If Yes , please document on the Adverse Event Report Forms

Datatyp

integer

Alias
UMLS CUI [1]
C0877248
Study Drug Dosing - Down Titration
Beskrivning

Study Drug Dosing - Down Titration

Alias
UMLS CUI-1
C0013175
UMLS CUI-2
C0678766
UMLS CUI-3
C2983683
Is the subject being down-titrated from 10mg to 8mg?
Beskrivning

Down-Titration

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0162621
UMLS CUI [1,2]
C0013175
UMLS CUI [1,3]
C0678766
Dosage given
Beskrivning

Dosage given

Datatyp

float

Måttenheter
  • mg/day
Alias
UMLS CUI [1]
C0678766
mg/day
Time of dosing
Beskrivning

Time of Dosing

Datatyp

time

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0040223
Witness 1
Beskrivning

Witness 1

Datatyp

text

Alias
UMLS CUI [1,1]
C0682356
UMLS CUI [1,2]
C0001555
Witness 2
Beskrivning

Witness 2

Datatyp

text

Alias
UMLS CUI [1,1]
C0682356
UMLS CUI [1,2]
C0001555
Witness date
Beskrivning

Witness date

Datatyp

date

Alias
UMLS CUI [1,1]
C4263486
UMLS CUI [1,2]
C0011008
Discharge - Down Titration
Beskrivning

Discharge - Down Titration

Alias
UMLS CUI-1
C0030685
UMLS CUI-2
C0162621
UMLS CUI-3
C0547047
Time of discharge from study site:
Beskrivning

Discharge Time

Datatyp

time

Alias
UMLS CUI [1]
C3864299
Date of next study visit
Beskrivning

Please note that subject must receive ropinirole 8mg PO, OD for a minimum of 3 days prior to proceeding to Treatment Period 1 Please ensure that the subject is dispensed enough medication until the next planned study visit

Datatyp

date

Alias
UMLS CUI [1]
C1545257
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Similar models

Study Drug Dosing - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Preliminary note
C1548998 (UMLS CUI-1)
daily dose of 8 mg ropinirole
Item
Is the subject receiving a daily dose of 8 mg ropinirole CR ?
boolean
C0244821 (UMLS CUI [1,1])
C2348070 (UMLS CUI [1,2])
daily dose > 8 mg ropinirole
Item
If NO: Is the subject receiving a daily dose > 8 mg ropinirole CR ?
boolean
C0244821 (UMLS CUI [1,1])
C2348070 (UMLS CUI [1,2])
Item Group
Patient diary
C3890583 (UMLS CUI-1)
Patient diary
Item
Patient diary
text
C3890583 (UMLS CUI [1])
Item Group
Pregnancy test
C0032976 (UMLS CUI-1)
Item
Was a pregnancy test performed?
integer
C0032976 (UMLS CUI [1])
pregnancy test
Code List
Was a pregnancy test performed?
CL Item
Yes (1)
CL Item
No (2)
CL Item
NA (male or female not of childbearing potential ) (3)
Item
If yes, what type of pregnancy test was performed?
integer
C0032976 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
type of pregnancy test
Code List
If yes, what type of pregnancy test was performed?
CL Item
Serum (1)
CL Item
Urine (2)
Date of pregnancy test
Item
If Yes, Date of Test
date
C0032976 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Result
integer
C0427777 (UMLS CUI [1])
Result of pregnancy test
Code List
Result
CL Item
Positive (1)
CL Item
Negative (2)
Item Group
Orthostatic blood pressure / Pulse measurement - Predose
C1095971 (UMLS CUI-1)
C0232117 (UMLS CUI-2)
C3812758 (UMLS CUI-3)
Date of visit
Item
Time point
date
C1320303 (UMLS CUI [1])
Heart rate Semi-Supine
Item
Heart Rate semi-supine
integer
C0018810 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Heart Rate standing
Item
Heart Rate standing
integer
C2029905 (UMLS CUI [1])
Systolic blood pressure semi-supine
Item
Systolic blood pressure semi-supine
integer
C0871470 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Diastolic blood pressure semi-supine
Item
Diastolic blood pressure semi-supine
integer
C0428883 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Systolic blood pressure standing
Item
Systolic blood pressure standing
integer
C0871470 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
Diastolic blood pressure standing
Item
Diastolic blood pressure standing
integer
C0428883 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
Item Group
Concomitant medication
C2347852 (UMLS CUI-1)
Item
Has the subject had any changes in medication since the last study visit?
integer
C0580105 (UMLS CUI [1])
changes in medication
Code List
Has the subject had any changes in medication since the last study visit?
CL Item
Yes (1)
CL Item
No (2)
Item
Have the subject's smoking habits remained unchanged?
integer
C0543414 (UMLS CUI [1,1])
C0442739 (UMLS CUI [1,2])
tobacco use
Code List
Have the subject's smoking habits remained unchanged?
CL Item
Yes (1)
CL Item
No (2)
Item Group
Adverse event
C0877248 (UMLS CUI-1)
Item
Has the subject experienced any Adverse Events since the previous clinic visit?
integer
C0877248 (UMLS CUI [1])
adverse event
Code List
Has the subject experienced any Adverse Events since the previous clinic visit?
CL Item
Yes (1)
CL Item
No (2)
Item Group
Study Drug Dosing
C0013175 (UMLS CUI-1)
C0678766 (UMLS CUI-2)
study drug dose
Item
Enter the dose of study drug prescribed at this visit
float
C0013227 (UMLS CUI [1,1])
C0013175 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
Time of first dose
Item
Time of first dose
time
C0178602 (UMLS CUI [1,1])
C0205435 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Witness 1
Item
Witness 1
text
C0682356 (UMLS CUI [1,1])
C0001555 (UMLS CUI [1,2])
Witness 2
Item
Witness 2
text
C0682356 (UMLS CUI [1,1])
C0001555 (UMLS CUI [1,2])
Witness date
Item
Witness date
date
C4263486 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Orthostatic blood pressure / pulse measurement - post dose
C1095971 (UMLS CUI-1)
C0232117 (UMLS CUI-2)
C0439568 (UMLS CUI-3)
Date of visit
Item
Time point
date
C1320303 (UMLS CUI [1])
Item
Post Dose
integer
C0439568 (UMLS CUI [1])
Post dose
Code List
Post Dose
CL Item
1h post dose (1)
CL Item
2h post dose (2)
CL Item
3h post dose (3)
CL Item
4h post dose (4)
Time post dose
Item
Time of post dose
time
C0439568 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Heart rate Semi-Supine
Item
Heart Rate semi-supine
integer
C0018810 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Heart Rate standing
Item
Heart Rate standing
integer
C2029905 (UMLS CUI [1])
Systolic blood pressure semi-supine
Item
Systolic blood pressure semi-supine
integer
C0871470 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Diastolic blood pressure semi-supine
Item
Diastolic blood pressure semi-supine
integer
C0428883 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Systolic blood pressure standing
Item
Systolic blood pressure standing
integer
C0871470 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
Diastolic blood pressure standing
Item
Diastolic blood pressure standing
integer
C0428883 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
Item Group
Adverse Event - 4 hours post dosing
C0877248 (UMLS CUI-1)
C0439574 (UMLS CUI-2)
Item
Has the subject experienced any Adverse Events since the time of dosing?
integer
C0877248 (UMLS CUI [1])
adverse event
Code List
Has the subject experienced any Adverse Events since the time of dosing?
CL Item
Yes (1)
CL Item
No (2)
Item Group
Discharge
C0030685 (UMLS CUI-1)
Discharge Time
Item
Time of discharge from study site:
time
C3864299 (UMLS CUI [1])
Date of next study visit
Item
Date of next study visit
date
C1545257 (UMLS CUI [1])
Item Group
Telephone call
C0302186 (UMLS CUI-1)
Item
Was a phone call made to the patient 72 hours after Titration Visit?
integer
C0199339 (UMLS CUI [1])
Phone call with patient
Code List
Was a phone call made to the patient 72 hours after Titration Visit?
CL Item
Yes (1)
CL Item
No (2)
Date of call
Item
Date of call
date
C0302186 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of call
Item
Time of call
time
C0302186 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item Group
Adverse events
C0877248 (UMLS CUI-1)
Item
Has the subject experienced any Adverse Events since discharge from the study site?
integer
C0877248 (UMLS CUI [1])
Adverse event
Code List
Has the subject experienced any Adverse Events since discharge from the study site?
CL Item
Yes (1)
CL Item
No (2)
Item Group
Study Drug Dosing - Down Titration
C0013175 (UMLS CUI-1)
C0678766 (UMLS CUI-2)
C2983683 (UMLS CUI-3)
Down-Titration
Item
Is the subject being down-titrated from 10mg to 8mg?
boolean
C0162621 (UMLS CUI [1,1])
C0013175 (UMLS CUI [1,2])
C0678766 (UMLS CUI [1,3])
Dosage given
Item
Dosage given
float
C0678766 (UMLS CUI [1])
Time of Dosing
Item
Time of dosing
time
C0178602 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Witness 1
Item
Witness 1
text
C0682356 (UMLS CUI [1,1])
C0001555 (UMLS CUI [1,2])
Witness 2
Item
Witness 2
text
C0682356 (UMLS CUI [1,1])
C0001555 (UMLS CUI [1,2])
Witness date
Item
Witness date
date
C4263486 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Discharge - Down Titration
C0030685 (UMLS CUI-1)
C0162621 (UMLS CUI-2)
C0547047 (UMLS CUI-3)
Discharge Time
Item
Time of discharge from study site:
time
C3864299 (UMLS CUI [1])
Date of next study visit
Item
Date of next study visit
date
C1545257 (UMLS CUI [1])
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