ID

41656

Beskrivning

Study ID: 110106 Clinical Study ID: 110106 Study Title: A single centre, randomized, double-blind, dose ascending, placebo-controlled study, in two parts, to evaluate the safety, tolerability and pharmacokinetics of escalating single and repeat inhaled doses of GSK573719 and placebo formulated with the excipient magnesium stearate, in healthy subjects and in a healthy population of Cytochrome P450 Isoenzyme 2D6 poor metabolisers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00803673 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK573719, Placebo Study Indication: Pulmonary Disease, Chronic Obstructive

Nyckelord

Versioner (1)
  1. 2020-12-05 2020-12-05 -
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GlaxoSmithKline

Uppladdad den

5 december 2020

DOI

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Creative Commons BY 4.0
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Safety, tolerability and pharmacokinetics of GSK573719 and placebo formulated with the excipient magnesium stearate NCT00803673

Engelsk

Follow-Up - ECG; Vital Signs; Pulmonary Function Test; Pregnancy Information; Status of treatment blind; Study conclusion

1 Formulär  
Date of visit/assessment
Beskrivning

Date of visit/assessment

Alias
UMLS CUI-1
C1320303
UMLS CUI-2
C2985720
Date of visit/assessment
Beskrivning

Date of visit/assessment

Datatyp

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C2985720
ECG
Beskrivning

ECG

Alias
UMLS CUI-1
C1623258
Date and Time of ECG
Beskrivning

Date and Time of ECG

Datatyp

datetime

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C1264639
Heart rate
Beskrivning

Heart rate

Datatyp

integer

Måttenheter
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
PR Interval
Beskrivning

PR Interval

Datatyp

integer

Måttenheter
  • ms
Alias
UMLS CUI [1]
C0429087
ms
QRS Duration
Beskrivning

QRS Duration

Datatyp

integer

Måttenheter
  • ms
Alias
UMLS CUI [1]
C0429025
ms
Uncorrected QT interval
Beskrivning

Uncorrected QT interval

Datatyp

integer

Måttenheter
  • ms
Alias
UMLS CUI [1]
C1287082
ms
QTc Interval
Beskrivning

QTc Interval

Datatyp

integer

Måttenheter
  • ms
Alias
UMLS CUI [1]
C0489625
ms
QTc(b) Interval
Beskrivning

QTc(b) Interval

Datatyp

integer

Måttenheter
  • ms
Alias
UMLS CUI [1]
C1882512
ms
Method of QTc Calculation
Beskrivning

Method of QTc Calculation

Datatyp

integer

Alias
UMLS CUI [1,1]
C0855331
UMLS CUI [1,2]
C2911685
Result of the ECG
Beskrivning

Result of the ECG

Datatyp

integer

Alias
UMLS CUI [1]
C0438154
Vital Signs - Follow-up 1
Beskrivning

Vital Signs - Follow-up 1

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C1522577
Vital Signs - Actual date/time
Beskrivning

Vital Signs - Actual date/time

Datatyp

datetime

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C1264639
Systolic Blood pressure
Beskrivning

Systolic Blood pressure

Datatyp

integer

Måttenheter
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Diastolic Blood Pressure
Beskrivning

Diastolic Blood Pressure

Datatyp

integer

Måttenheter
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Vital Signs - Heart rate
Beskrivning

Vital Signs - Heart rate

Datatyp

integer

Måttenheter
  • beats/min
Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0018810
beats/min
Vital Signs - Follow-up 2
Beskrivning

Vital Signs - Follow-up 2

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C1522577
Vital Signs - Actual date/time
Beskrivning

Vital Signs - Actual date/time

Datatyp

datetime

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C1264639
Systolic Blood pressure
Beskrivning

Systolic Blood pressure

Datatyp

integer

Måttenheter
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Diastolic Blood Pressure
Beskrivning

Diastolic Blood Pressure

Datatyp

integer

Måttenheter
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Vital Signs - Heart rate
Beskrivning

Vital Signs - Heart rate

Datatyp

integer

Måttenheter
  • beats/min
Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0018810
beats/min
Vital Signs - Follow-up 3
Beskrivning

Vital Signs - Follow-up 3

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C1522577
Vital Signs - Actual date/time
Beskrivning

Vital Signs - Actual date/time

Datatyp

datetime

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C1264639
Systolic Blood pressure
Beskrivning

Systolic Blood pressure

Datatyp

integer

Måttenheter
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Diastolic Blood Pressure
Beskrivning

Diastolic Blood Pressure

Datatyp

integer

Måttenheter
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Vital Signs - Heart rate
Beskrivning

Vital Signs - Heart rate

Datatyp

integer

Måttenheter
  • beats/min
Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0018810
beats/min
Pulmonary Function Tests
Beskrivning

Pulmonary Function Tests

Alias
UMLS CUI-1
C0024119
Date/time of test
Beskrivning

Date/time of test

Datatyp

datetime

Alias
UMLS CUI [1,1]
C0024119
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
FEV1 (3 readings) - 1
Beskrivning

FEV1 (3 readings) - 1

Datatyp

integer

Måttenheter
  • L
Alias
UMLS CUI [1]
C0748133
L
FEV1 (3 readings) - 2
Beskrivning

FEV1 (3 readings) - 2

Datatyp

integer

Måttenheter
  • L
Alias
UMLS CUI [1]
C0748133
L
FEV1 (3 readings) - 3
Beskrivning

FEV1 (3 readings) - 3

Datatyp

integer

Måttenheter
  • L
Alias
UMLS CUI [1]
C0748133
L
Pregnancy Information
Beskrivning

Pregnancy Information

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
Did the subject become pregnant during the study?
Beskrivning

If Yes, complete the paper Pregnancy Notofocation form

Datatyp

boolean

Alias
UMLS CUI [1]
C3828490
Did a female partner of the male subject become pregnant during the study?
Beskrivning

If Yes, complete the paper Pregnancy Notification form.

Datatyp

text

Alias
UMLS CUI [1]
C0919624
Status of Treatment Blind
Beskrivning

Status of Treatment Blind

Alias
UMLS CUI-1
C0749659
UMLS CUI-2
C2347038
Was the treatment blind broken during the study?
Beskrivning

If Yes, complete the Adverse Event form and/or Investigational Product forms as appropriate.

Datatyp

boolean

Alias
UMLS CUI [1]
C3897431
Date/time blind broken
Beskrivning

Date/time blind broken

Datatyp

datetime

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C1264639
Reason blind broken
Beskrivning

Reason blind broken

Datatyp

integer

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0392360
Specify other reason for blind broken
Beskrivning

Specify other reason for blind broken

Datatyp

text

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0392360
Study Conclusion
Beskrivning

Study Conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008972
Date of subject completion or withdrawal
Beskrivning

Date of subject completion or withdrawal

Datatyp

date

Alias
UMLS CUI [1]
C2983670
Was the subject withdrawn from the study?
Beskrivning

Was the subject withdrawn from the study?

Datatyp

boolean

Alias
UMLS CUI [1]
C0422727
Primary reason for withdrawal
Beskrivning

Primary reason for withdrawal

Datatyp

integer

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0392360
Case book ready for signature
Beskrivning

Case book ready for signature

Datatyp

text

Alias
UMLS CUI [1]
C1519316
Tillbaka till toppen

Similar models

Follow-Up - ECG; Vital Signs; Pulmonary Function Test; Pregnancy Information; Status of treatment blind; Study conclusion

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Date of visit/assessment
C1320303 (UMLS CUI-1)
C2985720 (UMLS CUI-2)
Date of visit/assessment
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item Group
ECG
C1623258 (UMLS CUI-1)
Date and Time of ECG
Item
Date and Time of ECG
datetime
C0013798 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
PR Interval
Item
PR Interval
integer
C0429087 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
integer
C0429025 (UMLS CUI [1])
Uncorrected QT interval
Item
Uncorrected QT interval
integer
C1287082 (UMLS CUI [1])
QTc Interval
Item
QTc Interval
integer
C0489625 (UMLS CUI [1])
QTc(b) Interval
Item
QTc(b) Interval
integer
C1882512 (UMLS CUI [1])
Item
Method of QTc Calculation
integer
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
Method of QTc Calculation
Code List
Method of QTc Calculation
CL Item
Machine (1)
CL Item
Manual (2)
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1])
Result of the ECG
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (complete the ECG abnormality form for all significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (3)
CL Item
No result (not available) (4)
Item Group
Vital Signs - Follow-up 1
C0518766 (UMLS CUI-1)
C1522577 (UMLS CUI-2)
Vital Signs - Actual date/time
Item
Vital Signs - Actual date/time
datetime
C0518766 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Systolic Blood pressure
Item
Systolic Blood pressure
integer
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Diastolic Blood Pressure
integer
C0428883 (UMLS CUI [1])
Vital Signs - Heart rate
Item
Vital Signs - Heart rate
integer
C0518766 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
Item Group
Vital Signs - Follow-up 2
C0518766 (UMLS CUI-1)
C1522577 (UMLS CUI-2)
Vital Signs - Actual date/time
Item
Vital Signs - Actual date/time
datetime
C0518766 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Systolic Blood pressure
Item
Systolic Blood pressure
integer
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Diastolic Blood Pressure
integer
C0428883 (UMLS CUI [1])
Vital Signs - Heart rate
Item
Vital Signs - Heart rate
integer
C0518766 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
Item Group
Vital Signs - Follow-up 3
C0518766 (UMLS CUI-1)
C1522577 (UMLS CUI-2)
Vital Signs - Actual date/time
Item
Vital Signs - Actual date/time
datetime
C0518766 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Systolic Blood pressure
Item
Systolic Blood pressure
integer
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Diastolic Blood Pressure
integer
C0428883 (UMLS CUI [1])
Vital Signs - Heart rate
Item
Vital Signs - Heart rate
integer
C0518766 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
Item Group
Pulmonary Function Tests
C0024119 (UMLS CUI-1)
Date/time of test
Item
Date/time of test
datetime
C0024119 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
FEV1 (3 readings) - 1
Item
FEV1 (3 readings) - 1
integer
C0748133 (UMLS CUI [1])
FEV1 (3 readings) - 2
Item
FEV1 (3 readings) - 2
integer
C0748133 (UMLS CUI [1])
FEV1 (3 readings) - 3
Item
FEV1 (3 readings) - 3
integer
C0748133 (UMLS CUI [1])
Item Group
Pregnancy Information
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Did the subject become pregnant during the study?
Item
Did the subject become pregnant during the study?
boolean
C3828490 (UMLS CUI [1])
Item
Did a female partner of the male subject become pregnant during the study?
text
C0919624 (UMLS CUI [1])
Did a female partner of the male subject become pregnant during the study?
Code List
Did a female partner of the male subject become pregnant during the study?
CL Item
No (N)
CL Item
Yes (Y)
CL Item
Not Applicable (Check Not Applicable if female partner not of childbearing potential or no female partner) (X)
Item Group
Status of Treatment Blind
C0749659 (UMLS CUI-1)
C2347038 (UMLS CUI-2)
Was the treatment blind broken during the study?
Item
Was the treatment blind broken during the study?
boolean
C3897431 (UMLS CUI [1])
Date/time blind broken
Item
Date/time blind broken
datetime
C3897431 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Item
Reason blind broken
integer
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Reason blind broken
Code List
Reason blind broken
CL Item
Medical emergency requiring identification of investigational product for further treatment (1)
CL Item
Other, specify (2)
Specify other reason for blind broken
Item
Specify other reason for blind broken
text
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Item Group
Study Conclusion
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Date of subject completion or withdrawal
Item
Date of subject completion or withdrawal
date
C2983670 (UMLS CUI [1])
Was the subject withdrawn from the study?
Item
Was the subject withdrawn from the study?
boolean
C0422727 (UMLS CUI [1])
Item
Primary reason for withdrawal
integer
C0422727 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Primary reason for withdrawal
Code List
Primary reason for withdrawal
CL Item
Adverse Event (Record detailson the Non-Serious Adverse Events or Serious Adverse Events forms as appropriate) (1)
CL Item
Study closed/terminated (2)
CL Item
Lost to Follow-Up (3)
CL Item
Withdrew consent (4)
Item
Case book ready for signature
text
C1519316 (UMLS CUI [1])
Case book ready for signature
Code List
Case book ready for signature
CL Item
Yes (Y)
Tillbaka till toppen 

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