ID

38620

Descrizione

Study ID: 111610 Clinical Study ID: 111610 Study Title: A randomised, double-blind, placebo-controlled study in healthy volunteers to examine the safety, tolerability and pharmacokinetics of a) single, ascending and b) twice-daily repeat doses of intranasal SB-705498. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00907933 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB705498, Placebo Study Indication: Rhinitis

Keywords

versioni (1)
  1. 28/10/19 28/10/19 -
Titolare del copyright

GlaxoSmithKline

Caricato su

28 ottobre 2019

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY-NC 3.0
Commenti del modello :

Puoi commentare il modello dati qui. Tramite i fumetti nei gruppi di articoli e articoli è possibile aggiungere commenti a quelli in modo specifico.

Torna ai commenti del modello
Commenti del gruppo di articoli per :

Commenti dell'articolo per :

Per scaricare i modelli di dati devi essere registrato. Per favore accesso o registrati GRATIS.

Safety, tolerability and pharmacokinetics of single, ascending and twice-daily repeat doses of intranasal SB-705498 NCT00907933

Inglese

Follow-Up - Dateof Visit; Status of Treatment Blind; Study Conclusion; Pregnancy Information

1 moduli  
Date of Visit
Descrizione

Date of Visit

Alias
UMLS CUI-1
C1320303
Date of Visit/ Assessment
Descrizione

Date of Visit/ Assessment

Tipo di dati

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C2985720
Status of Treatment Blind
Descrizione

Status of Treatment Blind

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

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

Tipo di dati

boolean

Alias
UMLS CUI [1]
C3897431
If treatment blind was broken during the study, enter date/ time blind broken.
Descrizione

If treatment blind was broken during the study, enter date/ time blind broken.

Tipo di dati

datetime

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0011008
UMLS CUI [2,1]
C3897431
UMLS CUI [2,2]
C0040223
Reason blind broken
Descrizione

Reason blind broken

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0392360
If other reason blind broken, please specify
Descrizione

If other reason blind broken, please specify

Tipo di dati

text

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
Study Conclusion
Descrizione

Study Conclusion

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

Date of last contact

Tipo di dati

date

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

Was the subject withdrawn from the study?

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0422727
If subject was withdrawn from study, please record date of decision to withdraw
Descrizione

If subject was withdrawn from study, please record date of decision to withdraw

Tipo di dati

date

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

Primary reason for withdrawal

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0392360
If investigator discretion, please specify
Descrizione

If investigator discretion, please specify

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0008961
UMLS CUI [1,2]
C0022423
UMLS CUI [1,3]
C2348235
Pregnancy Information (Preg F)
Descrizione

Pregnancy Information (Preg F)

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

Did the subject become pregnant during the study?

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0032961
Pregnancy Information (Preg M)
Descrizione

Pregnancy Information (Preg M)

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
Did a female partner of the male subject become pregnant during the study?
Descrizione

Check Not applicable if female partner not of childbearing potential or no female partner.

Tipo di dati

text

Alias
UMLS CUI [1]
C0919624
Ritorna all'inizio della pagina

Similar models

Follow-Up - Dateof Visit; Status of Treatment Blind; Study Conclusion; Pregnancy Information

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Date of Visit
C1320303 (UMLS CUI-1)
Date of Visit/ Assessment
Item
Date of Visit/ Assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
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])
If treatment blind was broken during the study, enter date/ time blind broken.
Item
If treatment blind was broken during the study, enter date/ time blind broken.
datetime
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C3897431 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
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)
If other reason blind broken, please specify
Item
If other reason blind broken, please specify
text
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item Group
Study Conclusion
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Date of last contact
Item
Date of last contact
date
C0805839 (UMLS CUI [1])
Was the subject withdrawn from the study?
Item
Was the subject withdrawn from the study?
boolean
C0422727 (UMLS CUI [1])
If subject was withdrawn from study, please record date of decision to withdraw
Item
If subject was withdrawn from study, please record date of decision to withdraw
date
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Primary reason for withdrawal
integer
C0422727 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Primary reasonfor withdrawal
Code List
Primary reason for withdrawal
CL Item
Adverse Event (Record details on the Non-Serious Adverse Events or Serious Adverse Events form as appropriate) (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 (select this reason if none of the other primary reasons are appropriate) (7)
CL Item
Withdrew consent (8)
If investigator discretion, please specify
Item
If investigator discretion, please specify
text
C0008961 (UMLS CUI [1,1])
C0022423 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item Group
Pregnancy Information (Preg F)
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
C0032961 (UMLS CUI [1])
Item Group
Pregnancy Information (Preg M)
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
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 (X)
Ritorna all'inizio della pagina 

Contatto

Si prega di utilizzare questo modulo per feedback, domande e suggerimenti per miglioramenti.

I campi contrassegnati da * sono obbligatori.

Aiuto

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial