ID

39348

Descrição

Study ID: 110792 Clinical Study ID: 110792 Study Title: A placebo-controlled, single-blind, randomised study to investigate the safety, tolerability, pharmacokinetics and drug interaction of GSK1034702 after repeat doses in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00950586 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Dextromethorphan, Placebo Trade Name: N/A Study Indication: Cognitive Disorders

Palavras-chave

Versões (1)
  1. 27/12/2019 27/12/2019 -
Titular dos direitos

GlaxoSmithKline

Transferido a

27 de dezembro de 2019

DOI

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Licença

Creative Commons BY-NC 3.0
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GSK1034702 after Repeat Doses in Healthy Subjects; NCT00950586

Inglês

Follow-up

1 Formulários  
  1. StudyEvent: ODM
    1. Follow-up
Date of Visit
Descrição

Date of Visit

Alias
UMLS CUI-1
C1320303
Date of visit/assessment
Descrição

Date of visit, Assessment Date

Tipo de dados

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C2985720
Vital Signs Semi-supine
Descrição

Vital Signs Semi-supine

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0522019
Actual date/time
Descrição

Vital signs, Semi-erect, Date in time, Time

Tipo de dados

datetime

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Blood pressure - Systolic
Descrição

Systolic Pressure, Semi-erect

Tipo de dados

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0522019
mm[Hg]
Blood pressure - Diastolic
Descrição

Diastolic blood pressure, Semi-erect

Tipo de dados

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0522019
mm[Hg]
Heart rate
Descrição

Heart rate, Semi-erect

Tipo de dados

integer

Unidades de medida
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0522019
bpm
Respiration rate
Descrição

Respiratory rate, Semi-erect

Tipo de dados

integer

Unidades de medida
  • breaths/min
Alias
UMLS CUI [1,1]
C0231832
UMLS CUI [1,2]
C0522019
breaths/min
Vital Signs Standing
Descrição

Vital Signs Standing

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0522014
Actual date/time
Descrição

Vital signs, Erect, Date in time, Time

Tipo de dados

datetime

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Blood pressure - Systolic
Descrição

Systolic Pressure, Erect

Tipo de dados

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0522014
mm[Hg]
Blood pressure - Diastolic
Descrição

Diastolic blood pressure, Erect

Tipo de dados

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0522014
mm[Hg]
Heart rate
Descrição

Heart rate, Erect

Tipo de dados

integer

Unidades de medida
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0522014
bpm
Pulmonary Function Tests
Descrição

Pulmonary Function Tests

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

Pulmonary function tests, Date in time, Time

Tipo de dados

datetime

Alias
UMLS CUI [1,1]
C0024119
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
FEV1
Descrição

Pulmonary function tests; Forced expiratory volume in 1 second finding

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0024119
UMLS CUI [1,2]
C0429706
VC/FVC
Descrição

Pulmonary function tests, Vital capacity, Forced Vital Capacity

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0024119
UMLS CUI [1,2]
C0042834
UMLS CUI [1,3]
C3714541
FEV1/VC
Descrição

Pulmonary function tests, Forced expired volume in one second/vital capacity ratio

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0024119
UMLS CUI [1,2]
C0429744
Status of Treatment Blind
Descrição

Status of Treatment Blind

Alias
UMLS CUI-1
C2347038
UMLS CUI-2
C0449438
Was the treatment blind broken during the study?
Descrição

Subject Unblinding Event Record

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3897431
Yes, Date/time blind broken
Descrição

Subject Unblinding Event Record, Date in time, Time

Tipo de dados

datetime

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
Yes, Reason blind broken
Descrição

Subject Unblinding Event Record, Reason and justification

Tipo de dados

text

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
Other, specify
Descrição

Subject Unblinding Event Record, Reason and justification

Tipo de dados

text

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
Study Conclusion
Descrição

Study Conclusion

Alias
UMLS CUI-1
C0008972
UMLS CUI-2
C1707478
Date of last contact
Descrição

Date last contact

Tipo de dados

date

Alias
UMLS CUI [1]
C0805839
Was the subject withdrawn from the study?
Descrição

Patient withdrawn from trial

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0422727
Yes, Date of decision to withdraw
Descrição

Patient withdrawn from trial, Decision, Date in time

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0679006
UMLS CUI [1,3]
C0011008
Yes, Primary reason for withdrawal
Descrição

Patient withdrawn from trial, Reason and justification, Primary

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C0205225
Specify
Descrição

Patient withdrawn from trial, Reason and justification, Primary

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C0205225
Case book ready for signature
Descrição

Clinical Study Case, Signature

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1706256
UMLS CUI [1,2]
C1519316
Pregnancy Information
Descrição

Pregnancy Information

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

Pregnancy, During, Clinical Trials

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0008976
Did a female partner of the male subject become pregnant during the study?
Descrição

Pregnancy of partner, During, Clinical Trials

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0919624
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0008976
Electronically Transferred Lab Data
Descrição

Electronically Transferred Lab Data

Alias
UMLS CUI-1
C0022885
Haematology Date and time sample taken
Descrição

Hematology finding, Sampling, Date in time, Time

Tipo de dados

datetime

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Not Done
Descrição

Hematology finding, Sampling, Not Done

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C1272696
Clinical Chemistry Date and time sample taken
Descrição

Chemistry, Clinical, Sampling, Date in time, Time

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Clinical Chemistry Date and time sample taken
Descrição

Chemistry, Clinical, Sampling, Date in time, Time

Tipo de dados

datetime

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Not Done
Descrição

Chemistry, Clinical, Sampling, Not Done

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C1272696
Urinalysis Date and time sample taken
Descrição

Urinalysis, Sampling, Date in time, Time

Tipo de dados

datetime

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Not Done
Descrição

Urinalysis, Sampling, Not Done

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C1272696
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Similar models

Follow-up

1 Formulários
  1. StudyEvent: ODM
    1. Follow-up
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Date of Visit
C1320303 (UMLS CUI-1)
Date of visit, Assessment Date
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item Group
Vital Signs Semi-supine
C0518766 (UMLS CUI-1)
C0522019 (UMLS CUI-2)
Vital signs, Semi-erect, Date in time, Time
Item
Actual date/time
datetime
C0518766 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Systolic Pressure, Semi-erect
Item
Blood pressure - Systolic
integer
C0871470 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
Diastolic blood pressure, Semi-erect
Item
Blood pressure - Diastolic
integer
C0428883 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
Heart rate, Semi-erect
Item
Heart rate
integer
C0018810 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
Respiratory rate, Semi-erect
Item
Respiration rate
integer
C0231832 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
Item Group
Vital Signs Standing
C0518766 (UMLS CUI-1)
C0522014 (UMLS CUI-2)
Vital signs, Erect, Date in time, Time
Item
Actual date/time
datetime
C0518766 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Systolic Pressure, Erect
Item
Blood pressure - Systolic
integer
C0871470 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
Diastolic blood pressure, Erect
Item
Blood pressure - Diastolic
integer
C0428883 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
Heart rate, Erect
Item
Heart rate
integer
C0018810 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
Item Group
Pulmonary Function Tests
C0024119 (UMLS CUI-1)
Pulmonary function tests, Date in time, Time
Item
Date/time of test
datetime
C0024119 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Pulmonary function tests; Forced expiratory volume in 1 second finding
Item
FEV1
text
C0024119 (UMLS CUI [1,1])
C0429706 (UMLS CUI [1,2])
Pulmonary function tests, Vital capacity, Forced Vital Capacity
Item
VC/FVC
text
C0024119 (UMLS CUI [1,1])
C0042834 (UMLS CUI [1,2])
C3714541 (UMLS CUI [1,3])
Pulmonary function tests, Forced expired volume in one second/vital capacity ratio
Item
FEV1/VC
text
C0024119 (UMLS CUI [1,1])
C0429744 (UMLS CUI [1,2])
Item Group
Status of Treatment Blind
C2347038 (UMLS CUI-1)
C0449438 (UMLS CUI-2)
Subject Unblinding Event Record
Item
Was the treatment blind broken during the study?
boolean
C3897431 (UMLS CUI [1])
Subject Unblinding Event Record, Date in time, Time
Item
Yes, Date/time blind broken
datetime
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item
Yes, Reason blind broken
text
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Subject Unblinding Event Record, Reason and justification
Code List
Yes, Reason blind broken
CL Item
Medical emergency requiring indication of investigational product for further treatment  (1)
CL Item
Other, specify (2)
Subject Unblinding Event Record, Reason and justification
Item
Other, specify
text
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item Group
Study Conclusion
C0008972 (UMLS CUI-1)
C1707478 (UMLS CUI-2)
Date last contact
Item
Date of last contact
date
C0805839 (UMLS CUI [1])
Patient withdrawn from trial
Item
Was the subject withdrawn from the study?
boolean
C0422727 (UMLS CUI [1])
Patient withdrawn from trial, Decision, Date in time
Item
Yes, Date of decision to withdraw
date
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Yes, Primary reason for withdrawal
text
C0422727 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
Patient withdrawn from trial, Reason and justification, Primary
Code List
Yes, Primary reason for withdrawal
CL Item
Adverse Event (1)
CL Item
Lack of efficacy (2)
CL Item
Protocol deviation (3)
CL Item
Subject reached protocol defined stopping criteria (4)
CL Item
Study closed/terminated (5)
CL Item
Lost to Follow-up (6)
CL Item
Investigator discretion, specify (7)
CL Item
Withdrew consent (8)
Patient withdrawn from trial, Reason and justification, Primary
Item
Specify
text
C0422727 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
Clinical Study Case, Signature
Item
Case book ready for signature
boolean
C1706256 (UMLS CUI [1,1])
C1519316 (UMLS CUI [1,2])
Item Group
Pregnancy Information
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Pregnancy, During, Clinical Trials
Item
Did the subject become pregnant during the study?
boolean
C0032961 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item
Did a female partner of the male subject become pregnant during the study?
text
C0919624 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Pregnancy of partner, During, Clinical Trials
Code List
Did a female partner of the male subject become pregnant during the study?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not applicable (3)
Item Group
Electronically Transferred Lab Data
C0022885 (UMLS CUI-1)
Hematology finding, Sampling, Date in time, Time
Item
Haematology Date and time sample taken
datetime
C0474523 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Hematology finding, Sampling, Not Done
Item
Not Done
boolean
C0474523 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Item
Clinical Chemistry Date and time sample taken
text
C0008000 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Chemistry, Clinical, Sampling, Date in time, Time
Code List
Clinical Chemistry Date and time sample taken
CL Item
Same as the Haematology sample (1)
Chemistry, Clinical, Sampling, Date in time, Time
Item
Clinical Chemistry Date and time sample taken
datetime
C0008000 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Chemistry, Clinical, Sampling, Not Done
Item
Not Done
boolean
C0008000 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Urinalysis, Sampling, Date in time, Time
Item
Urinalysis Date and time sample taken
datetime
C0042014 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Urinalysis, Sampling, Not Done
Item
Not Done
boolean
C0042014 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
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