ID

36027

Description

Study ID: 101468/198 Clinical Study ID: 101468/198 Study Title:An open, randomised, crossover, healthy volunteer study to compare the PK and tolerability of ropinirole as 3 different new formulations with the standard marketed formulation and to study the effects of a high fat meal on a new formulation 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 The Study consists of a Screening, 5 Sessions each with 2 days and a Follow-up. This document contains the concomitant medication form. It has to be filled in if the subject takes concomitant medication during the study trial. Please complete drug section for all drugs (including OTC)/ vaccines taken by mother within 3 months prior or during pregnancy.

Mots-clés

Versions (1)
  1. 09/04/2019 09/04/2019 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

9 avril 2019

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0
Modèle Commentaires :

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Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198

Anglais

Concomitant Medication

1 Formulaires  
  1. StudyEvent: ODM
    1. Concomitant Medication
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject No.
Description

Subject No.

Type de données

text

Alias
UMLS CUI [1]
C2348585
Panel ID
Description

Panel ID

Type de données

text

Alias
UMLS CUI [1]
C3846158
GSK Receipt Date
Description

day month year

Type de données

date

Alias
UMLS CUI [1]
C2985846
Concomitant Medication
Description

Concomitant Medication

Alias
UMLS CUI-1
C2347852
Are there any concomitant medication CHANGES since the start of the study?
Description

If 'YES', please record all medications used below. Where appropriate, medical conditions should be recorded on the Adverse Experiences Form, utilzing the same terminology. If a medication has had a dosage change it must be recorded with the start and stop date.

Type de données

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2169461
DRUG NAME
Description

(Trade Name Preferred)

Type de données

text

Alias
UMLS CUI [1]
C2360065
Single Dose/Unit
Description

Single Dose/Unit

Type de données

text

Alias
UMLS CUI [1]
C1960417
Frequency of this Dose
Description

Frequency of this Dose

Type de données

text

Alias
UMLS CUI [1]
C3476109
Route
Description

Other routes may be entered onto the form when appropriate, and will be coded prior to data entry.

Type de données

text

Alias
UMLS CUI [1]
C0013153
Indication
Description

Indication

Type de données

text

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0013227
Start Date
Description

day month year As a minimum the year must be stated.

Type de données

date

Alias
UMLS CUI [1]
C2826734
Start Time
Description

00:00-23:59

Type de données

time

Alias
UMLS CUI [1]
C2826740
End Date
Description

day month year

Type de données

date

Alias
UMLS CUI [1]
C2826744
End Time or check the following item if medication is continuing.
Description

00:00-23:59

Type de données

time

Alias
UMLS CUI [1]
C2826659
Continuing at end of study?
Description

Continuing at end of study

Type de données

boolean

Alias
UMLS CUI [1,1]
C1553904
UMLS CUI [1,2]
C2983670
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Similar models

Concomitant Medication

1 Formulaires
  1. StudyEvent: ODM
    1. Concomitant Medication
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject No.
Item
Subject No.
text
C2348585 (UMLS CUI [1])
Panel ID
Item
Panel ID
text
C3846158 (UMLS CUI [1])
GSK Receipt Date
Item
GSK Receipt Date
date
C2985846 (UMLS CUI [1])
Item Group
Concomitant Medication
C2347852 (UMLS CUI-1)
Concomitant medication changes
Item
Are there any concomitant medication CHANGES since the start of the study?
boolean
C2347852 (UMLS CUI [1,1])
C2169461 (UMLS CUI [1,2])
DRUG NAME
Item
DRUG NAME
text
C2360065 (UMLS CUI [1])
Single Dose/Unit
Item
Single Dose/Unit
text
C1960417 (UMLS CUI [1])
Frequency of this Dose
Item
Frequency of this Dose
text
C3476109 (UMLS CUI [1])
Item
Route
text
C0013153 (UMLS CUI [1])
Route
Code List
Route
CL Item
intra-articular (IA)
CL Item
intra-arterial (IAR)
CL Item
intra-dermal (ID)
CL Item
inhalation (IH)
CL Item
intra-muscular (IM)
CL Item
intra-thecal (IT)
CL Item
intra-venous (IV)
CL Item
nasal (NA)
CL Item
oral (PO)
CL Item
rectal (PR)
CL Item
subcutaneous (SC)
CL Item
sub lingual (SL)
CL Item
transdermal (TD)
CL Item
topical (TO)
CL Item
vaginal (VA)
Indication
Item
Indication
text
C3146298 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Start Date
Item
Start Date
date
C2826734 (UMLS CUI [1])
Start Time
Item
Start Time
time
C2826740 (UMLS CUI [1])
End Date
Item
End Date
date
C2826744 (UMLS CUI [1])
End Time
Item
End Time or check the following item if medication is continuing.
time
C2826659 (UMLS CUI [1])
Continuing at end of study
Item
Continuing at end of study?
boolean
C1553904 (UMLS CUI [1,1])
C2983670 (UMLS CUI [1,2])
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