Informatie:
Fout:
ID
25728
Beschrijving
Study ID: 101468/169 Clinical Study ID: 101468/169 Study Title:A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Six Months Treatment with Ropinirole CR as Adjunctive Therapy in Patients with Parkinson's Disease who are not Optimally Controlled on L-dopa Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00381472 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Parkinson Disease This is the Screening form.
Trefwoorden
Versies (1)
- 14-09-17 14-09-17 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
14 september 2017
DOI
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Licentie
Creative Commons BY-NC 3.0
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GSK Ropinirole in Patients Suffering from Parkinsons Disease Screening 101468/169 NCT00381472
GSK Ropinirole in Patients Suffering from Parkinsons Disease Screening 101468/169 NCT00381472
Similar models
GSK Ropinirole in Patients Suffering from Parkinsons Disease Screening 101468/169 NCT00381472
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
UNIFIED PARKINSON’S DISEASE RATING SCALE
C0030567 (UMLS CUI-1)
C0681889 (UMLS CUI-2)
C0681889 (UMLS CUI-2)
UNIFIED PARKINSON’S DISEASE RATING SCALE
Item
UNIFIED PARKINSON’S DISEASE RATING SCALE
text
C0030567 (UMLS CUI [1,1])
C0681889 (UMLS CUI [1,2])
C0681889 (UMLS CUI [1,2])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
CL Item
Female (F)
CL Item
Male (M)
CL Item
American Hispanic (1)
CL Item
Arabic/North African (2)
CL Item
Black (3)
CL Item
East & South East Asian (4)
CL Item
South Asian (5)
CL Item
White/Caucasian (6)
CL Item
Other (7)
Blood and lymphatic system disorders
Item
Blood and lymphatic system disorders
boolean
C0262926 (UMLS CUI [1,1])
C0851353 (UMLS CUI [1,2])
C0851353 (UMLS CUI [1,2])
Blood and lymphatic system disorders
Item
Blood and lymphatic system disorders
text
C0262926 (UMLS CUI [1,1])
C0851353 (UMLS CUI [1,2])
C0851353 (UMLS CUI [1,2])
Cardiac disorders
Item
Cardiac disorders
boolean
C0262926 (UMLS CUI [1,1])
C0018799 (UMLS CUI [1,2])
C0018799 (UMLS CUI [1,2])
Cardiac disorders
Item
Cardiac disorders
text
C0262926 (UMLS CUI [1,1])
C0018799 (UMLS CUI [1,2])
C0018799 (UMLS CUI [1,2])
Ear and labyrinth disorder
Item
Ear and labyrinth disorder
boolean
C0262926 (UMLS CUI [1,1])
C0851354 (UMLS CUI [1,2])
C0851354 (UMLS CUI [1,2])
Ear and labyrinth disorder
Item
Ear and labyrinth disorder
text
C0262926 (UMLS CUI [1,1])
C0851354 (UMLS CUI [1,2])
C0851354 (UMLS CUI [1,2])
Endocrine disorders
Item
Endocrine disorders
boolean
C0262926 (UMLS CUI [1,1])
C0014130 (UMLS CUI [1,2])
C0014130 (UMLS CUI [1,2])
Endocrine disorders
Item
Endocrine disorders
text
C0262926 (UMLS CUI [1,1])
C0014130 (UMLS CUI [1,2])
C0014130 (UMLS CUI [1,2])
Eye disorders
Item
Eye disorders
boolean
C0262926 (UMLS CUI [1,1])
C0015397 (UMLS CUI [1,2])
C0015397 (UMLS CUI [1,2])
Eye disorders
Item
Eye disorders
text
C0262926 (UMLS CUI [1,1])
C0015397 (UMLS CUI [1,2])
C0015397 (UMLS CUI [1,2])
Gastrointestinal disorders
Item
Gastrointestinal disorders
boolean
C0262926 (UMLS CUI [1,1])
C0017178 (UMLS CUI [1,2])
C0017178 (UMLS CUI [1,2])
Gastrointestinal disorders
Item
Gastrointestinal disorders
text
C0262926 (UMLS CUI [1,1])
C0017178 (UMLS CUI [1,2])
C0017178 (UMLS CUI [1,2])
Hepatobiliary disorders
Item
Hepatobiliary disorders
boolean
C0262926 (UMLS CUI [1,1])
C0267792 (UMLS CUI [1,2])
C0267792 (UMLS CUI [1,2])
Hepatobiliary disorders
Item
Hepatobiliary disorders
text
C0262926 (UMLS CUI [1,1])
C0267792 (UMLS CUI [1,2])
C0267792 (UMLS CUI [1,2])
Immune system disorders
Item
Immune system disorders
boolean
C0262926 (UMLS CUI [1,1])
C1334156 (UMLS CUI [1,2])
C1334156 (UMLS CUI [1,2])
Immune system disorders
Item
Immune system disorders
text
C0262926 (UMLS CUI [1,1])
C1334156 (UMLS CUI [1,2])
C1334156 (UMLS CUI [1,2])
Metabolism and nutrition disorders
Item
Metabolism and nutrition disorders
boolean
C0262926 (UMLS CUI [1,1])
C0851358 (UMLS CUI [1,2])
C0851358 (UMLS CUI [1,2])
Metabolism and nutrition disorders
Item
Metabolism and nutrition disorders
text
C0262926 (UMLS CUI [1,1])
C0851358 (UMLS CUI [1,2])
C0851358 (UMLS CUI [1,2])
Musculoskeletal and connective tissue disorders
Item
Musculoskeletal and connective tissue disorders
boolean
C0262926 (UMLS CUI [1,1])
C0263660 (UMLS CUI [1,2])
C0263660 (UMLS CUI [1,2])
Musculoskeletal and connective tissue disorders
Item
Musculoskeletal and connective tissue disorders
text
C0262926 (UMLS CUI [1,1])
C0263660 (UMLS CUI [1,2])
C0263660 (UMLS CUI [1,2])
Neoplasms benign, malignant and unspecified (inc. cysts and polyps)
Item
Neoplasms benign, malignant and unspecified (inc. cysts and polyps)
boolean
C0262926 (UMLS CUI [1,1])
C1882062 (UMLS CUI [1,2])
C1882062 (UMLS CUI [1,2])
Neoplasms benign, malignant and unspecified (inc. cysts and polyps)
Item
Neoplasms benign, malignant and unspecified (inc. cysts and polyps)
text
C0262926 (UMLS CUI [1,1])
C1882062 (UMLS CUI [1,2])
C1882062 (UMLS CUI [1,2])
Nervous system disorders
Item
Nervous system disorders
boolean
C0262926 (UMLS CUI [1,1])
C0810273 (UMLS CUI [1,2])
C0810273 (UMLS CUI [1,2])
Nervous system disorders
Item
Nervous system disorders
text
C0262926 (UMLS CUI [1,1])
C0810273 (UMLS CUI [1,2])
C0810273 (UMLS CUI [1,2])
Psychiatric disorders
Item
Psychiatric disorders
boolean
C0262926 (UMLS CUI [1,1])
C0004936 (UMLS CUI [1,2])
C0004936 (UMLS CUI [1,2])
Psychiatric disorders
Item
Psychiatric disorders
text
C0262926 (UMLS CUI [1,1])
C0004936 (UMLS CUI [1,2])
C0004936 (UMLS CUI [1,2])
Renal and urinary disorders
Item
Renal and urinary disorders
boolean
C0262926 (UMLS CUI [1,1])
C0042075 (UMLS CUI [1,2])
C0042075 (UMLS CUI [1,2])
Renal and urinary disorders
Item
Renal and urinary disorders
text
C0262926 (UMLS CUI [1,1])
C0042075 (UMLS CUI [1,2])
C0042075 (UMLS CUI [1,2])
Reproductive system and breast disorders
Item
Reproductive system and breast disorders
boolean
C0262926 (UMLS CUI [1,1])
C0851366 (UMLS CUI [1,2])
C0851366 (UMLS CUI [1,2])
Reproductive system and breast disorders
Item
Reproductive system and breast disorders
text
C0262926 (UMLS CUI [1,1])
C0851366 (UMLS CUI [1,2])
C0851366 (UMLS CUI [1,2])
Respiratory, thoracic and mediastinal disorders
Item
Respiratory, thoracic and mediastinal disorders
boolean
C0262926 (UMLS CUI [1,1])
C0851355 (UMLS CUI [1,2])
C0851355 (UMLS CUI [1,2])
Respiratory, thoracic and mediastinal disorders
Item
Respiratory, thoracic and mediastinal disorders
text
C0262926 (UMLS CUI [1,1])
C0851355 (UMLS CUI [1,2])
C0851355 (UMLS CUI [1,2])
Skin and subcutaneous tissue disorders
Item
Skin and subcutaneous tissue disorders
boolean
C0262926 (UMLS CUI [1,1])
C0037274 (UMLS CUI [1,2])
C0037274 (UMLS CUI [1,2])
Skin and subcutaneous tissue disorders
Item
Skin and subcutaneous tissue disorders
text
C0262926 (UMLS CUI [1,1])
C0037274 (UMLS CUI [1,2])
C0037274 (UMLS CUI [1,2])
Vascular disorders
Item
Vascular disorders
boolean
C0262926 (UMLS CUI [1,1])
C0042373 (UMLS CUI [1,2])
C0042373 (UMLS CUI [1,2])
Vascular disorders
Item
Vascular disorders
text
C0262926 (UMLS CUI [1,1])
C0042373 (UMLS CUI [1,2])
C0042373 (UMLS CUI [1,2])
Blood and lymphatic system disorders
Item
Blood and lymphatic system disorders
boolean
C3899485 (UMLS CUI [1,1])
C0851353 (UMLS CUI [1,2])
C0851353 (UMLS CUI [1,2])
Blood and lymphatic system disorders
Item
Blood and lymphatic system disorders
text
C3899485 (UMLS CUI [1,1])
C0851353 (UMLS CUI [1,2])
C0851353 (UMLS CUI [1,2])
Cardiac disorders
Item
Cardiac disorders
boolean
C3899485 (UMLS CUI [1,1])
C0018799 (UMLS CUI [1,2])
C0018799 (UMLS CUI [1,2])
Cardiac disorders
Item
Cardiac disorders
text
C3899485 (UMLS CUI [1,1])
C0018799 (UMLS CUI [1,2])
C0018799 (UMLS CUI [1,2])
Ear and labyrinth disorder
Item
Ear and labyrinth disorder
boolean
C3899485 (UMLS CUI [1,1])
C0851354 (UMLS CUI [1,2])
C0851354 (UMLS CUI [1,2])
Ear and labyrinth disorder
Item
Ear and labyrinth disorder
text
C3899485 (UMLS CUI [1,1])
C0851354 (UMLS CUI [1,2])
C0851354 (UMLS CUI [1,2])
Endocrine disorders
Item
Endocrine disorders
boolean
C3899485 (UMLS CUI [1,1])
C0014130 (UMLS CUI [1,2])
C0014130 (UMLS CUI [1,2])
Endocrine disorders
Item
Endocrine disorders
text
C3899485 (UMLS CUI [1,1])
C0014130 (UMLS CUI [1,2])
C0014130 (UMLS CUI [1,2])
Eye disorders
Item
Eye disorders
boolean
C3899485 (UMLS CUI [1,1])
C0015397 (UMLS CUI [1,2])
C0015397 (UMLS CUI [1,2])
Eye disorders
Item
Eye disorders
text
C3899485 (UMLS CUI [1,1])
C0015397 (UMLS CUI [1,2])
C0015397 (UMLS CUI [1,2])
Gastrointestinal disorders
Item
Gastrointestinal disorders
boolean
C3899485 (UMLS CUI [1,1])
C0017178 (UMLS CUI [1,2])
C0017178 (UMLS CUI [1,2])
Gastrointestinal disorders
Item
Gastrointestinal disorders
text
C3899485 (UMLS CUI [1,1])
C0017178 (UMLS CUI [1,2])
C0017178 (UMLS CUI [1,2])
Hepatobiliary disorders
Item
Hepatobiliary disorders
boolean
C3899485 (UMLS CUI [1,1])
C0267792 (UMLS CUI [1,2])
C0267792 (UMLS CUI [1,2])
Hepatobiliary disorders
Item
Hepatobiliary disorders
text
C3899485 (UMLS CUI [1,1])
C0267792 (UMLS CUI [1,2])
C0267792 (UMLS CUI [1,2])
Immune system disorders
Item
Immune system disorders
boolean
C3899485 (UMLS CUI [1,1])
C1334156 (UMLS CUI [1,2])
C1334156 (UMLS CUI [1,2])
Immune system disorders
Item
Immune system disorders
text
C3899485 (UMLS CUI [1,1])
C1334156 (UMLS CUI [1,2])
C1334156 (UMLS CUI [1,2])
Metabolism and nutrition disorders
Item
Metabolism and nutrition disorders
boolean
C3899485 (UMLS CUI [1,1])
C0851358 (UMLS CUI [1,2])
C0851358 (UMLS CUI [1,2])
Metabolism and nutrition disorders
Item
Metabolism and nutrition disorders
text
C3899485 (UMLS CUI [1,1])
C0851358 (UMLS CUI [1,2])
C0851358 (UMLS CUI [1,2])
Musculoskeletal and connective tissue disorders
Item
Musculoskeletal and connective tissue disorders
boolean
C3899485 (UMLS CUI [1,1])
C0263660 (UMLS CUI [1,2])
C0263660 (UMLS CUI [1,2])
Musculoskeletal and connective tissue disorders
Item
Musculoskeletal and connective tissue disorders
text
C3899485 (UMLS CUI [1,1])
C0263660 (UMLS CUI [1,2])
C0263660 (UMLS CUI [1,2])
Neoplasms benign, malignant and unspecified
Item
Neoplasms benign, malignant and unspecified (inc. cysts and polyps)
boolean
C3899485 (UMLS CUI [1,1])
C1882062 (UMLS CUI [1,2])
C1882062 (UMLS CUI [1,2])
Neoplasms benign, malignant and unspecified
Item
Neoplasms benign, malignant and unspecified (inc. cysts and polyps)
text
C3899485 (UMLS CUI [1,1])
C1882062 (UMLS CUI [1,2])
C1882062 (UMLS CUI [1,2])
Nervous system disorders
Item
Nervous system disorders
boolean
C3899485 (UMLS CUI [1,1])
C0810273 (UMLS CUI [1,2])
C0810273 (UMLS CUI [1,2])
Nervous system disorders
Item
Nervous system disorders
text
C3899485 (UMLS CUI [1,1])
C0810273 (UMLS CUI [1,2])
C0810273 (UMLS CUI [1,2])
Psychiatric disorders
Item
Psychiatric disorders
boolean
C3899485 (UMLS CUI [1,1])
C0004936 (UMLS CUI [1,2])
C0004936 (UMLS CUI [1,2])
Psychiatric disorders
Item
Psychiatric disorders
text
C3899485 (UMLS CUI [1,1])
C0004936 (UMLS CUI [1,2])
C0004936 (UMLS CUI [1,2])
Renal and urinary disorders
Item
Renal and urinary disorders
boolean
C3899485 (UMLS CUI [1,1])
C0042075 (UMLS CUI [1,2])
C0042075 (UMLS CUI [1,2])
Renal and urinary disorders
Item
Renal and urinary disorders
text
C3899485 (UMLS CUI [1,1])
C0042075 (UMLS CUI [1,2])
C0042075 (UMLS CUI [1,2])
Reproductive system and breast disorders
Item
Reproductive system and breast disorders
boolean
C3899485 (UMLS CUI [1,1])
C0851366 (UMLS CUI [1,2])
C0851366 (UMLS CUI [1,2])
Reproductive system and breast disorders
Item
Reproductive system and breast disorders
text
C3899485 (UMLS CUI [1,1])
C0851366 (UMLS CUI [1,2])
C0851366 (UMLS CUI [1,2])
Respiratory, thoracic and mediastinal disorders
Item
Respiratory, thoracic and mediastinal disorders
boolean
C3899485 (UMLS CUI [1,1])
C0851355 (UMLS CUI [1,2])
C0851355 (UMLS CUI [1,2])
Respiratory, thoracic and mediastinal disorders
Item
Respiratory, thoracic and mediastinal disorders
text
C3899485 (UMLS CUI [1,1])
C0851355 (UMLS CUI [1,2])
C0851355 (UMLS CUI [1,2])
Skin and subcutaneous tissue disorders
Item
Skin and subcutaneous tissue disorders
boolean
C3899485 (UMLS CUI [1,1])
C0037274 (UMLS CUI [1,2])
C0037274 (UMLS CUI [1,2])
Skin and subcutaneous tissue disorders
Item
Skin and subcutaneous tissue disorders
text
C3899485 (UMLS CUI [1,1])
C0037274 (UMLS CUI [1,2])
C0037274 (UMLS CUI [1,2])
Vascular disorders
Item
Vascular disorders
boolean
C3899485 (UMLS CUI [1,1])
C0042373 (UMLS CUI [1,2])
C0042373 (UMLS CUI [1,2])
Vascular disorders
Item
Vascular disorders
text
C3899485 (UMLS CUI [1,1])
C0042373 (UMLS CUI [1,2])
C0042373 (UMLS CUI [1,2])
Item Group
PRIOR PARKINSON’S MEDICATION
C0030567 (UMLS CUI-1)
C0013227 (UMLS CUI-2)
C0013227 (UMLS CUI-2)
Parkinson’s medication
Item
Has the subject taken any prior Parkinson’s medication within 30 days prior to the study (excluding L-Dopa)? If Yes, record each medication on a separate line using Trade Names where possible.
boolean
C0030567 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
Drug Name
Item
Drug Name
text
C2360065 (UMLS CUI [1,1])
C0030567 (UMLS CUI [1,2])
C0030567 (UMLS CUI [1,2])
Total Daily Dose
Item
Total Daily Dose
text
C2348070 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0030567 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,2])
C0030567 (UMLS CUI [1,3])
CL Item
Tablet (TAB)
CL Item
Microlitre (MCL)
CL Item
Millilitre (ML)
CL Item
Litre (L)
CL Item
Microgram (MCG)
CL Item
Milligram (MG)
CL Item
Gram (G)
CL Item
Intramuscular (IM)
CL Item
Inhalation (IH)
CL Item
Intravenous (IV)
CL Item
Nasal (NS)
CL Item
Topical (TP)
CL Item
Oral (PO)
CL Item
Vaginal (VG)
Reason for Medication
Item
Reason for Medication
text
C0030567 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
Start Date
Item
Start Date
date
C0030567 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Stop Date
Item
Stop Date
date
C0030567 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Ongoing Medication?
Item
Ongoing Medication?
boolean
C0030567 (UMLS CUI [1,1])
C2826666 (UMLS CUI [1,2])
C2826666 (UMLS CUI [1,2])
Item Group
L-DOPA MEDICATION HISTORY
C0013227 (UMLS CUI-1)
C0023570 (UMLS CUI-2)
C0023570 (UMLS CUI-2)
start taking L-Dopa
Item
When did the subject first start taking L-Dopa?
date
C0808070 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0023570 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,2])
C0023570 (UMLS CUI [1,3])
Item Group
PRIOR OR CONCOMITANT MEDICATIONS
C2347852 (UMLS CUI-1)
C2826257 (UMLS CUI-2)
C2826257 (UMLS CUI-2)
concomitant medications
Item
Were any concomitant medications taken by the subject within 30 days prior to the study (excluding parkinson’s medications)?
boolean
C2347852 (UMLS CUI [1,1])
C2826257 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C2826257 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
Drug Name
Item
Drug Name
text
C2347852 (UMLS CUI [1,1])
C2826257 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C2360065 (UMLS CUI [1,4])
C2826257 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C2360065 (UMLS CUI [1,4])
Total Daily Dose
Item
Total Daily Dose
text
C2347852 (UMLS CUI [1,1])
C2826257 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C2348070 (UMLS CUI [1,4])
C2826257 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C2348070 (UMLS CUI [1,4])
Item
Units
text
C2347852 (UMLS CUI [1,1])
C2826257 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C1519795 (UMLS CUI [1,4])
C2826257 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C1519795 (UMLS CUI [1,4])
CL Item
Tablet (TAB)
CL Item
Microlitre (MCL)
CL Item
Millilitre (ML)
CL Item
Litre (L)
CL Item
Microgram (MCG)
CL Item
Milligram (MG)
CL Item
Gram (G)
Item
Route
text
C2347852 (UMLS CUI [1,1])
C2826257 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0013153 (UMLS CUI [1,4])
C2826257 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0013153 (UMLS CUI [1,4])
CL Item
Intramuscular (IM)
CL Item
Inhalation (IH)
CL Item
Intravenous (IV)
CL Item
Nasal (NS)
CL Item
Topical (TP)
CL Item
Oral (PO)
CL Item
Vaginal (VG)
Reason for Medication
Item
Reason for Medication
text
C2347852 (UMLS CUI [1,1])
C2826257 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,4])
C2826257 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,4])
Start Date
Item
Start Date
date
C2347852 (UMLS CUI [1,1])
C2826257 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0808070 (UMLS CUI [1,4])
C2826257 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0808070 (UMLS CUI [1,4])
Stop Date
Item
Stop Date
date
C2347852 (UMLS CUI [1,1])
C2826257 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0806020 (UMLS CUI [1,4])
C2826257 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0806020 (UMLS CUI [1,4])
Ongoing Medication?
Item
Ongoing Medication?
boolean
C2347852 (UMLS CUI [1,1])
C2826257 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0549178 (UMLS CUI [1,4])
C2826257 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0549178 (UMLS CUI [1,4])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
integer
C0005910 (UMLS CUI [1])
Blood Pressure Systolic
Item
Blood Pressure Systolic
integer
C0871470 (UMLS CUI [1])
Blood Pressure Diastolic
Item
Blood Pressure Diastolic
integer
C0428883 (UMLS CUI [1])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Blood Pressure Systolic
Item
Blood Pressure Systolic
integer
C0871470 (UMLS CUI [1])
Blood Pressure Diastolic
Item
Blood Pressure Diastolic
integer
C0428883 (UMLS CUI [1])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal (2)
Mental Status Comment
Item
Mental Status Comment
text
C0004936 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal (2)
Gait Comment
Item
Gait Comment
text
C0016928 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal (2)
Balance Comment
Item
Balance Comment
text
C0560184 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal (2)
Coordination Comment
Item
Coordination Comment
text
C0242414 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal (2)
Cranial nerves
Item
Cranial nerves
text
C0010268 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal (2)
Motor
Item
Motor
text
C0234130 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal (2)
Reflexes
Item
Reflexes
text
C0034929 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal (2)
neurological examination
Item
Was the neurological examination consistent with the diagnosis of Parkinson’s disease? If NO, the subject is not eligible to participate in the study.
boolean
C0027853 (UMLS CUI [1,1])
C0030567 (UMLS CUI [1,2])
C0030567 (UMLS CUI [1,2])
Item Group
MODIFIED HOEHN AND YAHR PARKINSON’S DISEASE STAGING
C4274318 (UMLS CUI-1)
Date of onset of symptoms of parkinson’s disease
Item
Date of onset of symptoms of parkinson’s disease
date
C0030567 (UMLS CUI [1,1])
CL Item
Stage 0 No signs of disease. (1)
CL Item
Stage I Unilateral disease. (2)
CL Item
Stage I.5 Unilateral plus axial involvement. (3)
CL Item
Stage 2 Bilateral disease, without impairment of balance. (4)
CL Item
Stage 2.5 Mild Bilateral disease, with recovery on pull test. (5)
CL Item
Stage 3 Mild to moderate bilateral disease, some postural instability; physically independent. (6)
CL Item
Stage 4 Severe disability; still able to walk or stand unassisted. (7)
CL Item
Stage 5 Wheelchair bound or bedridden unless aided. (8)
surgical procedures
Item
Has the subject had any surgical procedures related to Parkinson’s disease?
boolean
C0543467 (UMLS CUI [1,1])
C0030567 (UMLS CUI [1,2])
C0030567 (UMLS CUI [1,2])
Date of procedure
Item
Date of procedure
date
C2584899 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0030567 (UMLS CUI [1,3])
C0543467 (UMLS CUI [1,2])
C0030567 (UMLS CUI [1,3])
Details
Item
Details
text
C0543467 (UMLS CUI [1,1])
C0030567 (UMLS CUI [1,2])
C0030567 (UMLS CUI [1,2])
Date of procedure
Item
Date of procedure
date
C2584899 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0030567 (UMLS CUI [1,3])
C0543467 (UMLS CUI [1,2])
C0030567 (UMLS CUI [1,3])
Details
Item
Details
text
C0543467 (UMLS CUI [1,1])
C0030567 (UMLS CUI [1,2])
C0030567 (UMLS CUI [1,2])
Date of procedure
Item
Date of procedure
date
C2584899 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0030567 (UMLS CUI [1,3])
C0543467 (UMLS CUI [1,2])
C0030567 (UMLS CUI [1,3])
Details
Item
Details
text
C0543467 (UMLS CUI [1,1])
C0030567 (UMLS CUI [1,2])
C0030567 (UMLS CUI [1,2])
Date of ECG
Item
Date of ECG
date
C2826640 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal - not clinically significant (2)
CL Item
Abnormal - clinically significant. Complete the current medical conditions page. (3)
Date sample taken
Item
Date sample taken
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
pregnancy test
Item
If subject is female and of childbearing potential a serum pregnancy test must be performed.
boolean
C0032976 (UMLS CUI [1])
physical examination
Item
Perform a physical examination on the subject Note: If any abnormalities are found as a result of the physical examination, these must be recorded on the Current Medical Conditions page
boolean
C0031809 (UMLS CUI [1])
entry criteria
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (UMLS CUI [1])
age, pregnancy
Item
Men or non-pregnant/non-breast-feeding women of at least 30 years of age at screening. Women of child-bearing potential must be practising a clinically accepted method of contraception (such as oral contraception, surgical sterilization, intrauterine device [IUD], or diaphram IN ADDITION to spermicidal foam and condom on male partner, or systemic contraception [i.e. Norplant], during the study and for at least one month prior to randomisation and one month following completion of the study.
boolean
C0001779 (UMLS CUI [1,1])
C0032961 (UMLS CUI [1,2])
C0021359 (UMLS CUI [1,3])
C0032961 (UMLS CUI [1,2])
C0021359 (UMLS CUI [1,3])
Parkinsons Disease L-dopa
Item
Diagnosis of idiopathic Parkinson’s Disease (according to modified Hoehn & Yahr criteria Stages IIIV) and demonstrating lack of control with L-dopa therapy (e.g. end of dose akinesia, simple on/off fluctuations)
boolean
C0030567 (UMLS CUI [1,1])
C0023570 (UMLS CUI [1,2])
C0205179 (UMLS CUI [1,3])
C0023570 (UMLS CUI [1,2])
C0205179 (UMLS CUI [1,3])
L-Dopa
Item
Subjects receiving a stable dose of L-dopa for at least four weeks prior to screening.
boolean
C0023570 (UMLS CUI [1])
informed consent
Item
Provide written informed consent for this study.
boolean
C0021430 (UMLS CUI [1])
compliance
Item
Be willing and able to comply with study procedures, including diary card completion and follow-up clinic visits.
boolean
C2348568 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
C1321605 (UMLS CUI [1,2])
Late stage advanced
Item
Late stage advanced subjects demonstrating incapacitating peak dose or biphasic dyskinsia on their stable dose of L-dopa.
boolean
C0023570 (UMLS CUI [1,1])
C0544467 (UMLS CUI [1,2])
C0030567 (UMLS CUI [1,3])
C0544467 (UMLS CUI [1,2])
C0030567 (UMLS CUI [1,3])
concomitant disease
Item
Presence, or history within the previous 3 months, of significant and/or uncontrolled psychiatric, hematological, renal, hepatic, endocrinological, neurological (other than Parkinson’s Disease), or cardiovascular disease or active malignancy (other than basal cell cancer).
boolean
C0243087 (UMLS CUI [1])
dizziness or fainting
Item
Recent history of severe dizziness or fainting due to postural hypotension on standing.
boolean
C0020651 (UMLS CUI [1,1])
C0012833 (UMLS CUI [1,2])
C0012833 (UMLS CUI [1,3])
C0012833 (UMLS CUI [1,2])
C0012833 (UMLS CUI [1,3])
dementia
Item
Clinical dementia that in the judgment of the investigator would preclude assessment of the subject.
boolean
C0497327 (UMLS CUI [1])
drug abuse alcoholism
Item
Recent history or current evidence of drug abuse or alcoholism.
boolean
C0001940 (UMLS CUI [1,1])
C0013146 (UMLS CUI [1,2])
C0013146 (UMLS CUI [1,2])
dopamine agonist
Item
Consumption of any dopamine agonist within four weeks of the start of the study.
boolean
C0178601 (UMLS CUI [1])
hypersensitivity to ropinirole
Item
Definite or suspected personal or family history of clinically significant adverse reactions or hypersensitivity to ropinirole (or to drugs with a similar chemical structure) that would preclude longterm dosing with ropinirole CR;
boolean
C0244821 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0020517 (UMLS CUI [1,2])
concomitant therapy
Item
Withdrawal, introduction, or change in dose of hormone replacement therapy and/or any drug known to substantially inhibit CYP1A2 (e.g. ciprofloxacine, fluvoxamine, cimetidine, ethinyloestradiol) or induce CYP1A2 (e.g. tobacco, omeprazole) within 7 days prior to enrolment. Subjects already on chronic therapy with any of these agents may be enrolled but must remain on stable doses of the agent from 7 days prior to enrolment through the end of the Treatment Period.
boolean
C1707479 (UMLS CUI [1,1])
C0282402 (UMLS CUI [1,2])
C3899737 (UMLS CUI [1,3])
C0282402 (UMLS CUI [1,2])
C3899737 (UMLS CUI [1,3])
investigational drug
Item
Use of an investigational drug within 30 days or 5 half-lives (which ever is longer).
boolean
C0013230 (UMLS CUI [1])
Dispense
Item
Dispense placebo run-in medication Record dispensing information in the Investigational Product and Compliance sections at the next visit.
boolean
C0947323 (UMLS CUI [1])
Week -2 Diary Card
Item
Issue the subject with the Week -2 Diary Card
boolean
C3890583 (UMLS CUI [1])