ID

41258

Beschrijving

Study ID: 103471 Clinical Study ID: 103471 Study Title: A randomised, double blind, placebo-controlled, double dummy, five-way cross over dose-escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single inhaled doses of GSK233705 (20-500µg via DPI), and, tiotropium bromide (18µg via DPI) in healthy male subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Darotropium Bromide Trade Name: Darotropium Bromide Study Indication: Chronic Obstructive Pulmonary Disease (COPD)

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  1. 28-07-20 28-07-20 -
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GlaxoSmithKline

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28 juli 2020

DOI

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Creative Commons BY 4.0
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Safety, tolerability, pharmacokinetics and pharmacodynamics of GSK233705 and tiotropium bromide (103471)

Engels

PGx-Pharmacogenetic Research; Concomitant Medications

1 Formulieren  
Administrative
Beschrijving

Administrative

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschrijving

Subject Identifier

Datatype

text

Alias
UMLS CUI [1]
C2348585
PGx-Pharmacogenetic Research
Beschrijving

PGx-Pharmacogenetic Research

Alias
UMLS CUI-1
C2347500
Has informed consent been obtained for PGx-Pharmacogenetic research?
Beschrijving

Has informed consent been obtained for PGx-Pharmacogenetic research?

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
Date informed consnet obtained for PGx-Pharmacogenetic research
Beschrijving

Date informed consnet obtained for PGx-Pharmacogenetic research

Datatype

date

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
UMLS CUI [1,3]
C0011008
If no informed consent has been obtained, check one reason
Beschrijving

If no informed consent has been obtained, check one reason

Datatype

text

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C1882120
UMLS CUI [1,4]
C0566251
Has a blood sample (DNA) been collected for PGx-pharmacogenetic research?
Beschrijving

Has a blood sample (DNA) been collected for PGx-pharmacogenetic research?

Datatype

boolean

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0005834
Date sample taken
Beschrijving

Date sample taken

Datatype

date

Alias
UMLS CUI [1]
C1302413
Has subject withdrawn consent for PGx-Pharmacogenetic research?
Beschrijving

Has subject withdrawn consent for PGx-Pharmacogenetic research?

Datatype

boolean

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C2349954
Has a request been made for sample destruction?
Beschrijving

Has a request been made for sample destruction?

Datatype

boolean

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C1272683
If a request has been made for sample destruction, check one reason
Beschrijving

If a request has been made for sample destruction, check one reason

Datatype

text

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C1272683
UMLS CUI [1,4]
C0392360
If other reason for request for sample destruction, specify
Beschrijving

If other reason for request for sample destruction, specify

Datatype

text

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C1272683
UMLS CUI [1,4]
C0392360
UMLS CUI [2,1]
C0205394
UMLS CUI [2,2]
C2348235
Concomitant Medications
Beschrijving

Concomitant Medications

Alias
UMLS CUI-1
C2347852
Were any concomitant medications taken by the subject during the study?
Beschrijving

Were any concomitant medications taken by the subject during the study?

Datatype

boolean

Alias
UMLS CUI [1]
C2347852
Concomitant Medications
Beschrijving

Concomitant Medications

Alias
UMLS CUI-1
C2347852
Drug Name
Beschrijving

Trade Name preferred

Datatype

text

Alias
UMLS CUI [1]
C0013227
Unit Dose
Beschrijving

Unit Dose

Datatype

float

Alias
UMLS CUI [1]
C0869039
Units
Beschrijving

Units

Datatype

text

Alias
UMLS CUI [1]
C1519795
Frequency
Beschrijving

Frequency

Datatype

text

Alias
UMLS CUI [1]
C3476109
Route
Beschrijving

Route

Datatype

text

Alias
UMLS CUI [1]
C0013153
Reason for Medication
Beschrijving

Reason for Medication

Datatype

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0013227
Medication Start Date
Beschrijving

Medication Start Date

Datatype

date

Alias
UMLS CUI [1]
C2826734
Medication Start Time
Beschrijving

Medication Start Time

Datatype

time

Alias
UMLS CUI [1,1]
C2826734
UMLS CUI [1,2]
C1301880
Medication taken prior to study?
Beschrijving

Medication taken prior to study?

Datatype

boolean

Alias
UMLS CUI [1]
C2826667
Medication Stop Date
Beschrijving

Medication Stop Date

Datatype

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Medication Stop Time
Beschrijving

Medication Stop Time

Datatype

time

Alias
UMLS CUI [1]
C2826659
Ongoing Medication?
Beschrijving

Ongoing Medication?

Datatype

boolean

Alias
UMLS CUI [1]
C2826666
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Similar models

PGx-Pharmacogenetic Research; Concomitant Medications

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Item Group
PGx-Pharmacogenetic Research
C2347500 (UMLS CUI-1)
Has informed consent been obtained for PGx-Pharmacogenetic research?
Item
Has informed consent been obtained for PGx-Pharmacogenetic research?
boolean
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
Date informed consnet obtained for PGx-Pharmacogenetic research
Item
Date informed consnet obtained for PGx-Pharmacogenetic research
date
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
If no informed consent has been obtained, check one reason
text
C2347500 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C1882120 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
If no informed consent has been obtained, check one reason
Code List
If no informed consent has been obtained, check one reason
CL Item
Subject declined (1)
CL Item
Subject not asked by Investigator (2)
CL Item
Other, specify (Z)
Has a blood sample (DNA) been collected for PGx-pharmacogenetic research?
Item
Has a blood sample (DNA) been collected for PGx-pharmacogenetic research?
boolean
C2347500 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
Date sample taken
Item
Date sample taken
date
C1302413 (UMLS CUI [1])
Has subject withdrawn consent for PGx-Pharmacogenetic research?
Item
Has subject withdrawn consent for PGx-Pharmacogenetic research?
boolean
C2347500 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,3])
Has a request been made for sample destruction?
Item
Has a request been made for sample destruction?
boolean
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
Item
If a request has been made for sample destruction, check one reason
text
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,4])
If a request has been made for sample destruction, check one reason
Code List
If a request has been made for sample destruction, check one reason
CL Item
Subject requested (1)
CL Item
Screen failure (2)
CL Item
Other, specify (Z)
If other reason for request for sample destruction, specify
Item
If other reason for request for sample destruction, specify
text
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,4])
C0205394 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
Item Group
Concomitant Medications
C2347852 (UMLS CUI-1)
Were any concomitant medications taken by the subject during the study?
Item
Were any concomitant medications taken by the subject during the study?
boolean
C2347852 (UMLS CUI [1])
Item Group
Concomitant Medications
C2347852 (UMLS CUI-1)
Drug Name
Item
Drug Name
text
C0013227 (UMLS CUI [1])
Unit Dose
Item
Unit Dose
float
C0869039 (UMLS CUI [1])
Item
Units
text
C1519795 (UMLS CUI [1])
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)
Item
Frequency
text
C3476109 (UMLS CUI [1])
Frequency
Code List
Frequency
CL Item
1 x Daily (OD/QD)
CL Item
2 x Daily (BID)
CL Item
3 x Daily (TID)
CL Item
4 x Daily (QID)
CL Item
As required (PRN)
Item
Route
text
C0013153 (UMLS CUI [1])
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)
Reason for Medication
Item
Reason for Medication
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Medication Start Date
Item
Medication Start Date
date
C2826734 (UMLS CUI [1])
Medication Start Time
Item
Medication Start Time
time
C2826734 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Medication taken prior to study?
Item
Medication taken prior to study?
boolean
C2826667 (UMLS CUI [1])
Medication Stop Date
Item
Medication Stop Date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Medication Stop Time
Item
Medication Stop Time
time
C2826659 (UMLS CUI [1])
Ongoing Medication?
Item
Ongoing Medication?
boolean
C2826666 (UMLS CUI [1])
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