ID

36390

Beschreibung

Study ID: 101468/201 Clinical Study ID: 101468/201 Study Title: A Single Blind, Parallel Group, Up-titration, Phase 1 Study in Healthy Volunteers to Determine a Starting Dose and Select an Up-titration Regimen for a new Formulation of Ropinirole 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 21 Visits(Days): Screening (at least 21 days before dosing) Week 1: including Day 1-7 Week 2: including Day 8-14 Week 3: including Day 15-19 Follow-up Visit (7-14 days after last dose) This document contains the informed consent and demographic of subject form. It has to be filled in for screening.

Stichworte

Versionen (2)
  1. 31.08.17 31.08.17 -
  2. 10.05.19 10.05.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

10. Mai 2019

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Determination of starting dose and up-titration regimen for a new formulation of Ropinirole in healthy adults, 101468/201

Englisch

Informed consent, Demography

1 Formulare  
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Volunteer panel number
Beschreibung

Identification number

Datentyp

integer

Alias
UMLS CUI [1]
C1300638
Subject number
Beschreibung

Subject number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Informed Consent History
Beschreibung

Informed Consent History

Alias
UMLS CUI-1
C0021430
Has the subject given written informed consent prior to any study procedures being performed?
Beschreibung

Informed consent

Datentyp

text

Alias
UMLS CUI [1]
C0021430
Date of written informed consent
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1]
C2985782
DEMOGRAPHY
Beschreibung

DEMOGRAPHY

Alias
UMLS CUI-1
C0011298
Date of birth
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Gender
Beschreibung

Gender

Datentyp

text

Alias
UMLS CUI [1]
C0079399
Race
Beschreibung

Race

Datentyp

integer

Alias
UMLS CUI [1]
C0034510
If other Race, please specify
Beschreibung

Other Race

Datentyp

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0034510
Height
Beschreibung

Height

Datentyp

integer

Maßeinheiten
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Beschreibung

Weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body mass index
Beschreibung

Body mass index calculated using the following formula: Body Mass Index = ( Weight (kg) / (Height (cm) )² ) x 10,000

Datentyp

float

Maßeinheiten
  • kg/m²
Alias
UMLS CUI [1]
C1305855
kg/m²
Clinical Staff Signature
Beschreibung

Clinical Staff Signature

Datentyp

text

Alias
UMLS CUI [1,1]
C0025106
UMLS CUI [1,2]
C1519316
Date of signature
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Ähnliche Modelle

Informed consent, Demography

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Identification number
Item
Volunteer panel number
integer
C1300638 (UMLS CUI [1])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
Informed Consent History
C0021430 (UMLS CUI-1)
Item
Has the subject given written informed consent prior to any study procedures being performed?
text
C0021430 (UMLS CUI [1])
Informed consent
Code List
Has the subject given written informed consent prior to any study procedures being performed?
CL Item
Yes (Y)
CL Item
No (N)
Date of informed consent
Item
Date of written informed consent
date
C2985782 (UMLS CUI [1])
Item Group
DEMOGRAPHY
C0011298 (UMLS CUI-1)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Gender
text
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
Female (F)
CL Item
Male (M)
Item
Race
integer
C0034510 (UMLS CUI [1])
Race
Code List
Race
CL Item
American Hispanic (1)
C0019576 (UMLS CUI-1)
(Comment:en)
CL Item
Arabic/North African (2)
C0238604 (UMLS CUI-1)
(Comment:en)
CL Item
Black (3)
C0005680 (UMLS CUI-1)
(Comment:en)
CL Item
East & South East Asian (4)
C0003983 (UMLS CUI-1)
(Comment:en)
CL Item
Japanese (5)
C1556094 (UMLS CUI-1)
(Comment:en)
CL Item
South Asian (6)
C1519427 (UMLS CUI-1)
(Comment:en)
CL Item
White/Caucasian (7)
C0043157 (UMLS CUI-1)
(Comment:en)
CL Item
Other (8)
C0205394 (UMLS CUI-1)
(Comment:en)
Other Race
Item
If other Race, please specify
text
C0205394 (UMLS CUI [1,1])
C0034510 (UMLS CUI [1,2])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Body mass index
Item
Body mass index
float
C1305855 (UMLS CUI [1])
Clinical Staff Signature
Item
Clinical Staff Signature
text
C0025106 (UMLS CUI [1,1])
C1519316 (UMLS CUI [1,2])
Date of signature
Item
Date of signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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