ID

26000

Beskrivning

PART B - Period 2 - Day 1 - 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 Study Indication: Restless Legs Syndrome

Nyckelord

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

glaxoSmithKline

Uppladdad den

3 oktober 2017

DOI

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Licens

Creative Commons BY-NC 3.0
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PART B - Period 2 - Day 1 - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

Engelsk

PART B - Period 2 - Day 1 - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

1 Formulär  
Note
Beskrivning

Note

Alias
UMLS CUI-1
C1317574
Has the subject been taking 8mg ropinirole CR daily for at least 3 days
Beskrivning

Please note that the subject must have been receiving ropinirole 8 mg daily for a minimum of 3 days prior to continuing with Part B Treatment Period 1 of this study

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0678766
UMLS CUI [1,2]
C0244821
Physical examination
Beskrivning

Physical examination

Alias
UMLS CUI-1
C0031809
Body system
Beskrivning

Body system

Datatyp

integer

Alias
UMLS CUI [1,1]
C1268086
UMLS CUI [1,2]
C0449913
Body system abnormality
Beskrivning

Body system abnormality

Datatyp

integer

Alias
UMLS CUI [1,1]
C0460002
UMLS CUI [1,2]
C1704258
Describe abnormality
Beskrivning

Describe abnormality body system

Datatyp

text

Alias
UMLS CUI [1,1]
C0459424
UMLS CUI [1,2]
C0031809
UMLS CUI [1,3]
C0678257
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

pregnancy test

Datatyp

integer

Alias
UMLS CUI [1]
C0032976
Date of pregnancy 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
Alcohol breath/ blood test
Beskrivning

Alcohol breath/ blood test

Alias
UMLS CUI-1
C0202304
Time
Beskrivning

Perform Alcohol Breath/Blood Test and attach printout

Datatyp

time

Alias
UMLS CUI [1,1]
C0202304
UMLS CUI [1,2]
C0040223
Result
Beskrivning

Result of alcohol test

Datatyp

integer

Alias
UMLS CUI [1,1]
C0202304
UMLS CUI [1,2]
C1274040
Subjects MUST refrain from consuming alcohol for 24h prior to the screening and follow - up visits and for 24 hours before and throughout Parts A and B Has this subject consumed alcohol within the previous 24h?
Beskrivning

alcohol consumption

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0443288
Drug screening (urine)
Beskrivning

Drug screening (urine)

Alias
UMLS CUI-1
C0202274
Time
Beskrivning

Time of drug screening

Datatyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0202274
Cannabinoids
Beskrivning

Cannabinoids urine

Datatyp

integer

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0006864
Morphine and morphine derivates
Beskrivning

Morphine and morphine derivates urine

Datatyp

integer

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0279996
Amphetamine
Beskrivning

Amphetamine urine

Datatyp

integer

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0002667
Barbiturates
Beskrivning

Barbiturates urine

Datatyp

integer

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0004745
Benzodiazepines
Beskrivning

Benzodiazepines urine

Datatyp

integer

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0005064
Cocaine
Beskrivning

Cocaine urine

Datatyp

integer

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0009170
Tricyclic antidepressants
Beskrivning

Tricyclic antidepressants urine

Datatyp

integer

Alias
UMLS CUI [1]
C0003290
If positive, give further details.
Beskrivning

Urine drug screening positive specify

Datatyp

text

Alias
UMLS CUI [1,1]
C2711519
UMLS CUI [1,2]
C1521902
Orthostatic blood pressure / Pulse - Predose
Beskrivning

Orthostatic blood pressure / Pulse - Predose

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C1095971
UMLS CUI-3
C0232117
UMLS CUI-4
C3812758
Date of visit
Beskrivning

For the pre-dose measurements in Part A, Day 1 of Periods 1 and 2, and Part B, Day 1 of Periods 1 and 2, 3 sets of semi-supine and erect blood pressure and pulse measurements will be taken, commencing approximately 40 minutes prior to dosing and each set will be separated by 10 minutes rest in the semi- supine position. Three stable measurements should be recorded In this instance stable is defined as the three semi-supine diastolic measurements being within 15 mmHg of the lowest measurement. This rule also applies for the semi-supine systolic and erect systolic and diastolic measurements. A maximum of six attempts can be made to obtain measurements pre-dose. If three consecutive stable measurements of blood pressure cannot be obtained then the Investigator should contact the Medical Monitor to discuss whether the patient can be included/continue in the study.

Datatyp

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C3812758
Heart Rate semi-supine
Beskrivning

Heart rate Semi-Supine

Datatyp

integer

Måttenheter
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0038846
UMLS CUI [1,3]
C3812758
bpm
Heart Rate standing
Beskrivning

Heart Rate standing

Datatyp

integer

Måttenheter
  • bpm
Alias
UMLS CUI [1,1]
C2029905
UMLS CUI [1,2]
C3812758
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
UMLS CUI [1,3]
C3812758
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
UMLS CUI [1,3]
C3812758
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
UMLS CUI [1,3]
C3812758
mmHg
Diastolic blood pressure standing
Beskrivning

Diastolic blood pressure standing

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1,1]
C1303019
UMLS CUI [1,2]
C3812758
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
Has the subject complied with suggested dietary restrictions?
Beskrivning

dietary restrictions

Datatyp

integer

Alias
UMLS CUI [1,1]
C0425422
UMLS CUI [1,2]
C1321605
Adverse event
Beskrivning

Adverse event

Alias
UMLS CUI-1
C0877248
Has the subject experienced any Adverse Events since the last study contact?
Beskrivning

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

Datatyp

integer

Alias
UMLS CUI [1]
C0877248
Patient diary
Beskrivning

Patient diary

Alias
UMLS CUI-1
C3890583
Please collect and review the Patient Diary with the subject. If corrections or additional information are required, please ask the subject to provide missing information or clarification. Please use the Comments CRF pages as necessary. Document any missed doses on the appropriate CRF page. Please inform the subject that he/she should bring back the diary at the next visit.
Beskrivning

Patient diary

Datatyp

text

Alias
UMLS CUI [1]
C3890583
Randomization
Beskrivning

Randomization

Alias
UMLS CUI-1
C0034656
Confirm that Inclusion and Exclusion Criteria have been reviewed at this visit:
Beskrivning

eligibility determination

Datatyp

boolean

Alias
UMLS CUI [1]
C0013893
Does the subject continue to meet criteria for enrollment in Part B?
Beskrivning

study subject participation status eligibility

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0013893
Subject is randomized to:
Beskrivning

Randomization

Datatyp

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C1522541
High fat breakfast
Beskrivning

High fat breakfast

Alias
UMLS CUI-1
C2698559
UMLS CUI-2
C0521974
High fat breakfast started
Beskrivning

High fat breakfast started

Datatyp

time

Alias
UMLS CUI [1,1]
C2698559
UMLS CUI [1,2]
C0521974
UMLS CUI [1,3]
C0439659
High fat breakfast ended
Beskrivning

The suggested time for breakfast is 20 minutes

Datatyp

time

Alias
UMLS CUI [1,1]
C2698559
UMLS CUI [1,2]
C0521974
UMLS CUI [1,3]
C0444930
Did the subject complete the breakfast?
Beskrivning

Breakfast completed

Datatyp

integer

Alias
UMLS CUI [1,1]
C0814440
UMLS CUI [1,2]
C0205197
If no, please comment:
Beskrivning

Breakfast not completed comment

Datatyp

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C0814440
UMLS CUI [1,3]
C0205197
Study Drug Dosing
Beskrivning

Study Drug Dosing

Alias
UMLS CUI-1
C0013175
UMLS CUI-2
C0678766
Ropinirole 8 mg administered at:
Beskrivning

The subject will not be allowed to lie down or sleep for 4 hours after the morning dose

Datatyp

time

Måttenheter
  • 24hr:min
Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0040223
24hr:min
Witness 1
Beskrivning

Witness 1

Datatyp

text

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

Witness date 1

Datatyp

date

Alias
UMLS CUI [1,1]
C4263486
UMLS CUI [1,2]
C0011008
Witness 2
Beskrivning

Witness 2

Datatyp

text

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

Witness date 2

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
UMLS CUI [1,3]
C0439568
bpm
Heart Rate standing
Beskrivning

Heart Rate standing

Datatyp

integer

Måttenheter
  • bpm
Alias
UMLS CUI [1,1]
C2029905
UMLS CUI [1,2]
C0439568
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
UMLS CUI [1,3]
C0439568
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
UMLS CUI [1,3]
C0439568
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
UMLS CUI [1,3]
C0439568
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
UMLS CUI [1,3]
C0439568
mmHg
Adverse Event - post dosing
Beskrivning

Adverse Event - post dosing

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C0439568
Has the subject experienced any Adverse Events at 4 hours post dosing?
Beskrivning

If Yes , please document on the Adverse Event Report Forms

Datatyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0439574
Has the subject experienced any Adverse Events at 12 hours post dosing?
Beskrivning

If Yes , please document on the Adverse Event Report Forms

Datatyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1439442
Has the subject experienced any Adverse Events at 24 hours post dosing?
Beskrivning

If Yes , please document on the Adverse Event Report Forms

Datatyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1439477
Pharmacokinetic sampling post dosing
Beskrivning

Pharmacokinetic sampling post dosing

Alias
UMLS CUI-1
C0031328
Sample ID and specified time
Beskrivning

Sample ID and specified time

Datatyp

integer

Alias
UMLS CUI [1,1]
C1299222
UMLS CUI [1,2]
C1444698
Actual time
Beskrivning

Actual time pharmacokinetics

Datatyp

time

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0040223
Date
Beskrivning

Date sample

Datatyp

date

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C1302413
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
Tillbaka till toppen

Similar models

PART B - Period 2 - Day 1 - 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
Note
C1317574 (UMLS CUI-1)
continuation status ropinirole
Item
Has the subject been taking 8mg ropinirole CR daily for at least 3 days
boolean
C0678766 (UMLS CUI [1,1])
C0244821 (UMLS CUI [1,2])
Item Group
Physical examination
C0031809 (UMLS CUI-1)
Item
Body system
integer
C1268086 (UMLS CUI [1,1])
C0449913 (UMLS CUI [1,2])
Body system
Code List
Body system
CL Item
General appearance and skin (1)
CL Item
Head, eyes, ears, nose, throat (2)
CL Item
Cardiovascular (3)
CL Item
Respiratory (4)
CL Item
Abdominal and gastrointestinal (5)
CL Item
Musculoskeletal (6)
CL Item
Neurological (7)
CL Item
Genitourinary (8)
CL Item
Other (9)
Item
Body system abnormality
integer
C0460002 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Body system abnormality
Code List
Body system abnormality
CL Item
normal (1)
CL Item
abnormal (2)
CL Item
not done/ not applicable (3)
Describe abnormality body system
Item
Describe abnormality
text
C0459424 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
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 (3)
Item
If yes, what type of pregnancy test was performed?
integer
C0032976 (UMLS CUI [1])
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
Date of pregnancy 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
Alcohol breath/ blood test
C0202304 (UMLS CUI-1)
Time of alcohol test
Item
Time
time
C0202304 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Result
integer
C0202304 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Result of alcohol test
Code List
Result
CL Item
negative (1)
CL Item
positive (2)
alcohol consumption
Item
Subjects MUST refrain from consuming alcohol for 24h prior to the screening and follow - up visits and for 24 hours before and throughout Parts A and B Has this subject consumed alcohol within the previous 24h?
boolean
C0001948 (UMLS CUI [1,1])
C0443288 (UMLS CUI [1,2])
Item Group
Drug screening (urine)
C0202274 (UMLS CUI-1)
Time of drug screening
Item
Time
time
C0040223 (UMLS CUI [1,1])
C0202274 (UMLS CUI [1,2])
Item
Cannabinoids
integer
C0202274 (UMLS CUI [1,1])
C0006864 (UMLS CUI [1,2])
Cannabinoids urine
Code List
Cannabinoids
CL Item
negative (1)
CL Item
positive (2)
Item
Morphine and morphine derivates
integer
C0202274 (UMLS CUI [1,1])
C0279996 (UMLS CUI [1,2])
Morphine and morphine derivates urine
Code List
Morphine and morphine derivates
CL Item
negative (1)
CL Item
positive (2)
Item
Amphetamine
integer
C0202274 (UMLS CUI [1,1])
C0002667 (UMLS CUI [1,2])
Amphetamine urine
Code List
Amphetamine
CL Item
negative (1)
CL Item
positive (2)
Item
Barbiturates
integer
C0202274 (UMLS CUI [1,1])
C0004745 (UMLS CUI [1,2])
Barbiturates urine
Code List
Barbiturates
CL Item
negative (1)
CL Item
positive (2)
Item
Benzodiazepines
integer
C0202274 (UMLS CUI [1,1])
C0005064 (UMLS CUI [1,2])
Benzodiazepines urine
Code List
Benzodiazepines
CL Item
negative (1)
CL Item
positive (2)
Item
Cocaine
integer
C0202274 (UMLS CUI [1,1])
C0009170 (UMLS CUI [1,2])
Cocaine urine
Code List
Cocaine
CL Item
negative (1)
CL Item
positive (2)
Item
Tricyclic antidepressants
integer
C0003290 (UMLS CUI [1])
Tricyclic antidepressants urine
Code List
Tricyclic antidepressants
CL Item
negative (1)
CL Item
positive (2)
Urine drug screening positive specify
Item
If positive, give further details.
text
C2711519 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Item Group
Orthostatic blood pressure / Pulse - Predose
C0518766 (UMLS CUI-1)
C1095971 (UMLS CUI-2)
C0232117 (UMLS CUI-3)
C3812758 (UMLS CUI-4)
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1,1])
C3812758 (UMLS CUI [1,2])
Heart rate Semi-Supine
Item
Heart Rate semi-supine
integer
C0018810 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C3812758 (UMLS CUI [1,3])
Heart Rate standing
Item
Heart Rate standing
integer
C2029905 (UMLS CUI [1,1])
C3812758 (UMLS CUI [1,2])
Systolic blood pressure semi-supine
Item
Systolic blood pressure semi-supine
integer
C0871470 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C3812758 (UMLS CUI [1,3])
Diastolic blood pressure semi-supine
Item
Diastolic blood pressure semi-supine
integer
C0428883 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C3812758 (UMLS CUI [1,3])
Systolic blood pressure standing
Item
Systolic blood pressure standing
integer
C0871470 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
C3812758 (UMLS CUI [1,3])
Diastolic blood pressure standing
Item
Diastolic blood pressure standing
integer
C1303019 (UMLS CUI [1,1])
C3812758 (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 unchanged
Code List
Have the subject's smoking habits remained unchanged?
CL Item
Yes (1)
CL Item
No (2)
Item
Has the subject complied with suggested dietary restrictions?
integer
C0425422 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
dietary restrictions
Code List
Has the subject complied with suggested dietary restrictions?
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 last study contact?
integer
C0877248 (UMLS CUI [1])
adverse event
Code List
Has the subject experienced any Adverse Events since the last study contact?
CL Item
Yes (1)
CL Item
No (2)
Item Group
Patient diary
C3890583 (UMLS CUI-1)
Patient diary
Item
Please collect and review the Patient Diary with the subject. If corrections or additional information are required, please ask the subject to provide missing information or clarification. Please use the Comments CRF pages as necessary. Document any missed doses on the appropriate CRF page. Please inform the subject that he/she should bring back the diary at the next visit.
text
C3890583 (UMLS CUI [1])
Item Group
Randomization
C0034656 (UMLS CUI-1)
eligibility determination
Item
Confirm that Inclusion and Exclusion Criteria have been reviewed at this visit:
boolean
C0013893 (UMLS CUI [1])
study subject participation status eligibility
Item
Does the subject continue to meet criteria for enrollment in Part B?
boolean
C2348568 (UMLS CUI [1,1])
C0013893 (UMLS CUI [1,2])
Item
Subject is randomized to:
integer
C0034656 (UMLS CUI [1,1])
C1522541 (UMLS CUI [1,2])
Randomization
Code List
Subject is randomized to:
CL Item
Continued fast (until at least 4 hours post dosing) (1)
CL Item
High fat breakfast (2)
Item Group
High fat breakfast
C2698559 (UMLS CUI-1)
C0521974 (UMLS CUI-2)
High fat breakfast started
Item
High fat breakfast started
time
C2698559 (UMLS CUI [1,1])
C0521974 (UMLS CUI [1,2])
C0439659 (UMLS CUI [1,3])
High fat breakfast ended
Item
High fat breakfast ended
time
C2698559 (UMLS CUI [1,1])
C0521974 (UMLS CUI [1,2])
C0444930 (UMLS CUI [1,3])
Item
Did the subject complete the breakfast?
integer
C0814440 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Breakfast completed
Code List
Did the subject complete the breakfast?
CL Item
Yes (1)
CL Item
No (2)
CL Item
NA (3)
Breakfast not completed comment
Item
If no, please comment:
text
C0947611 (UMLS CUI [1,1])
C0814440 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
Item Group
Study Drug Dosing
C0013175 (UMLS CUI-1)
C0678766 (UMLS CUI-2)
Time of Dosing
Item
Ropinirole 8 mg administered at:
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 date 1
Item
Witness date 1
date
C4263486 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Witness 2
Item
Witness 2
text
C0682356 (UMLS CUI [1,1])
C0001555 (UMLS CUI [1,2])
Witness date 2
Item
Witness date 2
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)
CL Item
24h post dose (5)
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])
C0439568 (UMLS CUI [1,3])
Heart Rate standing
Item
Heart Rate standing
integer
C2029905 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
Systolic blood pressure semi-supine
Item
Systolic blood pressure semi-supine
integer
C0871470 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
Diastolic blood pressure semi-supine
Item
Diastolic blood pressure semi-supine
integer
C0428883 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
Systolic blood pressure standing
Item
Systolic blood pressure standing
integer
C0871470 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
Diastolic blood pressure standing
Item
Diastolic blood pressure standing
integer
C0428883 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
Item Group
Adverse Event - post dosing
C0877248 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
Item
Has the subject experienced any Adverse Events at 4 hours post dosing?
integer
C0877248 (UMLS CUI [1,1])
C0439574 (UMLS CUI [1,2])
adverse event
Code List
Has the subject experienced any Adverse Events at 4 hours post dosing?
CL Item
Yes (1)
CL Item
No (2)
Item
Has the subject experienced any Adverse Events at 12 hours post dosing?
integer
C0877248 (UMLS CUI [1,1])
C1439442 (UMLS CUI [1,2])
Adverse event 12 hours post dose
Code List
Has the subject experienced any Adverse Events at 12 hours post dosing?
CL Item
Yes (1)
CL Item
no (2)
Item
Has the subject experienced any Adverse Events at 24 hours post dosing?
integer
C0877248 (UMLS CUI [1,1])
C1439477 (UMLS CUI [1,2])
Adverse Events 24 hours post dose
Code List
Has the subject experienced any Adverse Events at 24 hours post dosing?
CL Item
Yes (1)
CL Item
No (2)
Item Group
Pharmacokinetic sampling post dosing
C0031328 (UMLS CUI-1)
Item
Sample ID and specified time
integer
C1299222 (UMLS CUI [1,1])
C1444698 (UMLS CUI [1,2])
Sample ID and specified time
Code List
Sample ID and specified time
CL Item
1h (1)
CL Item
2h (2)
CL Item
4h (3)
CL Item
6h (4)
CL Item
8h (5)
CL Item
10h (6)
CL Item
12h (7)
CL Item
14h (8)
CL Item
16h (9)
CL Item
20h (10)
CL Item
24h (11)
Actual time pharmacokinetics
Item
Actual time
time
C0031328 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Date sample
Item
Date
date
C0031328 (UMLS CUI [1,1])
C1302413 (UMLS CUI [1,2])
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])
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