ID

43527

Description

Documentation Part: Screening An Open Label, Repeat Dose, Dose Escalation Study Conducted in Parkinson's Disease Patients to Characterize the Pharmacokinetics and Effect of Food on Ropinirole Prolonged Release (PR/CR) 12mg Tablets. ClinicalTrials.gov Identifier: NCT00460148 https://clinicaltrials.gov/ct2/show/NCT00460148?term=NCT00460148&rank=1 Responsible Party: GlaxoSmithKline

Link

https://clinicaltrials.gov/ct2/show/NCT00460148?term=NCT00460148&rank=1

Keywords

Versions (2)
  1. 4/25/17 4/25/17 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY-NC 3.0
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Screening Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148

English

Screening Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148

1 forms  
Subject Information
Description

Subject Information

Alias
UMLS CUI-1
C2707520
Subject identifier
Description

Subject identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Description

Visit Date

Data type

date

Measurement units
  • Day Month Year
Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C0220908
Day Month Year
Demography
Description

Demography

Alias
UMLS CUI-1
C0011298
Date of birth
Description

Date of birth

Data type

date

Measurement units
  • Day Month Year
Alias
UMLS CUI [1]
C0421451
Day Month Year
Sex
Description

Sex

Data type

text

Alias
UMLS CUI [1]
C0079399
Ethnicity
Description

Ethnicity

Data type

text

Alias
UMLS CUI [1]
C0015031
Geographic Ancestry
Description

Geographic Ancestry

Data type

text

Alias
UMLS CUI [1]
C0034510
Child-bearing Potential (Complete for Female Subjects Only)
Description

Child-bearing Potential (Complete for Female Subjects Only)

Alias
UMLS CUI-1
C1960468
Child-bearing Potential: Check one
Description

Child-bearing Potential: Check one

Data type

text

Alias
UMLS CUI [1,1]
C1960468
UMLS CUI [1,2]
C0015895
Pregnancy Test (Complete for Female Subjects of Child-bearing Potential Only)
Description

Pregnancy Test (Complete for Female Subjects of Child-bearing Potential Only)

Alias
UMLS CUI-1
C0032976
Date sample taken
Description

Date sample taken

Data type

date

Measurement units
  • Day Month Year
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0032976
Day Month Year
Results
Description

Results

Data type

text

Alias
UMLS CUI [1,1]
C0587081
UMLS CUI [1,2]
C0032976
Local Laboratory Result Data
Description

Local Laboratory Result Data

Alias
UMLS CUI-1
C1254595
FSH/LH Result
Description

FSH/LH Result

Data type

text

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C2122182
Medical Conditions
Description

Medical Conditions

Alias
UMLS CUI-1
C0012634
UMLS CUI-2
C0009488
Diagnosis
Description

Only in the absence of a diagnosis, record the signs and symptoms on separate lines

Data type

text

Alias
UMLS CUI [1]
C0011900
Current
Description

Current

Data type

boolean

Alias
UMLS CUI [1,1]
C0521116
UMLS CUI [1,2]
C0012634
Past
Description

Past

Data type

boolean

Alias
UMLS CUI [1,1]
C1444637
UMLS CUI [1,2]
C0012634
Urine Drug Screen
Description

Urine Drug Screen

Alias
UMLS CUI-1
C0202274
Date and time of sample taken
Description

Date and time of sample taken

Data type

datetime

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
Amphetamines
Description

Amphetamines

Data type

text

Alias
UMLS CUI [1]
C0002667
Barbiturates
Description

Barbiturates

Data type

text

Alias
UMLS CUI [1]
C0004745
Cannabis
Description

Cannabis

Data type

text

Alias
UMLS CUI [1]
C0936079
Cocaine
Description

Cocaine

Data type

text

Alias
UMLS CUI [1]
C0009170
Morphine and derivatives
Description

Morphine and derivatives

Data type

text

Alias
UMLS CUI [1]
C0279996
Alcohol Test
Description

Alcohol Test

Alias
UMLS CUI-1
C0868676
Date sample taken
Description

Date sample taken

Data type

date

Measurement units
  • Day Month Year
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0868676
Day Month Year
Results, check one
Description

Results, check one

Data type

text

Alias
UMLS CUI [1,1]
C0587081
UMLS CUI [1,2]
C0868676
Serology - HIV/Hepatitis Screen
Description

Serology - HIV/Hepatitis Screen

Alias
UMLS CUI-1
C0459958
UMLS CUI-2
C1445958
Date sample taken
Description

Date sample taken

Data type

date

Measurement units
  • Day Month Year
Alias
UMLS CUI [1,1]
C0459958
UMLS CUI [1,2]
C1445958
UMLS CUI [1,3]
C1302413
Day Month Year
HIV antibody
Description

HIV antibody

Data type

text

Alias
UMLS CUI [1]
C0019683
Hepatitis B surface antigen
Description

Hepatitis B surface antigen

Data type

text

Alias
UMLS CUI [1]
C0019168
Hepatitis C antibody
Description

Hepatitis C antibody

Data type

text

Alias
UMLS CUI [1]
C0281863
Physical examination
Description

Physical examination

Alias
UMLS CUI-1
C0031809
Date of Assessment
Description

Date of Assessment

Data type

date

Measurement units
  • Day Month Year
Alias
UMLS CUI [1,1]
C2985720
UMLS CUI [1,2]
C0031809
Day Month Year
If ABNORMAL, describe concisely:
Description

[different findings should be separated by either a (;) or a (/)]

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0243095
UMLS CUI [1,3]
C0678257
Hair and skin
Description

Hair and skin

Data type

text

Alias
UMLS CUI [1,1]
C0018494
UMLS CUI [1,2]
C0558035
If ABNORMAL, describe concisely:
Description

[different findings should be separated by either a (;) or a (/)]

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0243095
UMLS CUI [1,3]
C0678257
Lymph nodes
Description

Lymph nodes

Data type

text

Alias
UMLS CUI [1]
C0024204
If ABNORMAL, describe concisely:
Description

[different findings should be separated by either a (;) or a (/)]

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0243095
UMLS CUI [1,3]
C0678257
Eyes
Description

Eyes

Data type

text

Alias
UMLS CUI [1]
C0200149
If ABNORMAL, describe concisely:
Description

[different findings should be separated by either a (;) or a (/)]

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0243095
UMLS CUI [1,3]
C0678257
Ears, Nose and Throat
Description

Ears, Nose and Throat

Data type

text

Alias
UMLS CUI [1]
C0278350
If ABNORMAL, describe concisely:
Description

[different findings should be separated by either a (;) or a (/)]

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0243095
UMLS CUI [1,3]
C0678257
Breasts
Description

Breasts

Data type

text

Alias
UMLS CUI [1]
C0199850
If ABNORMAL, describe concisely:
Description

[different findings should be separated by either a (;) or a (/)]

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0243095
UMLS CUI [1,3]
C0678257
Respiratory
Description

Respiratory

Data type

text

Alias
UMLS CUI [1]
C0436121
If ABNORMAL, describe concisely:
Description

[different findings should be separated by either a (;) or a (/)]

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0243095
UMLS CUI [1,3]
C0678257
Cardiovascular
Description

Cardiovascular

Data type

text

Alias
UMLS CUI [1]
C3854344
If ABNORMAL, describe concisely:
Description

[different findings should be separated by either a (;) or a (/)]

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0243095
UMLS CUI [1,3]
C0678257
Abdomen
Description

Abdomen

Data type

text

Alias
UMLS CUI [1]
C0562238
If ABNORMAL, describe concisely:
Description

[different findings should be separated by either a (;) or a (/)]

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0243095
UMLS CUI [1,3]
C0678257
Urogenital
Description

Urogenital

Data type

text

Alias
UMLS CUI [1]
C1828035
If ABNORMAL, describe concisely:
Description

[different findings should be separated by either a (;) or a (/)]

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0243095
UMLS CUI [1,3]
C0678257
Pelvic