GSK Ropinirole in Patients Suffering from Parkinsons Disease L-Dopa Medication 101468/169 NCT00381472

ID

25747

Descrição

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 L-Dopa Medication form.

Palavras-chave

Drug trial

Levodopa

Concomitant Medication

Clinical Trial, Phase III

Parkinsons Disease

17/09/2017 17/09/2017 -
28/09/2017 28/09/2017 -

Titular dos direitos

GlaxoSmithKline

Transferido a

17 de setembro de 2017

DOI

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Licença

Creative Commons BY-NC 3.0

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1 Formulários

StudyEvent: ODM
1. GSK Ropinirole in Patients Suffering from Parkinsons Disease L-Dopa Medication 101468/169 NCT00381472

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

L-DOPA MEDICATION

Item Group

L-DOPA MEDICATION

C0023570 (UMLS CUI-1)

Was any L-Dopa taken by the subject during the study or within 30 days prior to the study?

Item

Was any L-Dopa taken by the subject during the study or within 30 days prior to the study? If Yes, record each instance below.

boolean

C0023570 (UMLS CUI [1])

Drug Name

Item

Drug Name

text

C0023570 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0023570 (UMLS CUI [1,3])

Unit Dose

Item

Unit Dose

text

C0013227 (UMLS CUI [1,1])
C0023570 (UMLS CUI [1,2])
C0023570 (UMLS CUI [1,3])
C0869039 (UMLS CUI [1,4])

Units

Item

Units

text

C1519795 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0023570 (UMLS CUI [1,3])

Units

Code List

Units

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)

Frequency

Item

Frequency

text

C1519795 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0023570 (UMLS CUI [1,3])

Units

Code List

Frequency

CL Item

1x Daily (OD)

CL Item

2x Daily (BID)

CL Item

3x Daily (TID)

CL Item

4x Daily (QID)

CL Item

As required (PRN)

Route

Item

Route

text

C0013153 (UMLS CUI [1,1])
C0023570 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])

Route

Code List

Route

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

C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0023570 (UMLS CUI [1,3])

Start Date

Item

Start Date

date

C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0023570 (UMLS CUI [1,3])

Stop Date

Item

Stop Date

date

C0806020 (UMLS CUI [1,1])
C0023570 (UMLS CUI [1,2])

Ongoing Medication?

Item

Ongoing Medication?

boolean

C0549178 (UMLS CUI [1,1])
C0023570 (UMLS CUI [1,2])

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Titular dos direitos

Transferido a

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Licença

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GSK Ropinirole in Patients Suffering from Parkinsons Disease L-Dopa Medication 101468/169 NCT00381472