ID

34844

Descrição

Study ID: 101888 Clinical Study ID: FFR101888 Study Title: A randomised, placebo-controlled, four way crossover study to evaluate the effect of double-blind 4000 mcg of orally inhaled GW685698X and of 6.25 mg cellobiose octa-acetate on electrocardiographic parameters, with single-blind 400 mg of oral moxifloxacin as a positive control, in 40 healthy male and female subjects. 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: fluticasone furoate Trade Name: Veramyst,Avamys,Allermist Study Indication: Rhinitis, Allergic, Perennial The study consists of a screening, 4 treatment periods (TP) and a follow-up visit. For each TP there is a Day-1 (D-1) and a Day1 (D1). This document contains the status of treatment blind form, study conclusion, pregnancy information, investigator's comment and signature. It has to be filled in for the end of study.

Palavras-chave

Versões (3)
  1. 29/01/2019 29/01/2019 -
  2. 29/01/2019 29/01/2019 -
  3. 31/01/2019 31/01/2019 -
Titular dos direitos

GlaxoSmithKline

Transferido a

31 de janeiro de 2019

DOI

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Licença

Creative Commons BY-NC 3.0
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Effect of inhaled Fluticasone furoate and cellobiose octa-acetate on electrocardiographic parameters in healthy subjects, Study-ID: 101888

Inglês

Status of treatment blind, study conclusion, pregnancy information, investigator's comment and signature

1 Formulários  
Administrative data
Descrição

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Descrição

Subject Identifier

Tipo de dados

text

Alias
UMLS CUI [1]
C2348585
Status of treatment blind
Descrição

Status of treatment blind

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

If Yes, complete the following items.

Tipo de dados

text

Alias
UMLS CUI [1]
C3897431
Date blind broken
Descrição

day month year

Tipo de dados

date

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0011008
Time blind broken
Descrição

00:00-23:59

Tipo de dados

time

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0040223
Reason blind broken, tick one
Descrição

Complete Non-Serious Adverse Events, Serious Adverse Event and/or lnvestigational Product pages, as appropriate.

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0566251
If other reason blind broken, please specify
Descrição

Complete Non-Serious Adverse Events, Serious Adverse Event and/or lnvestigational Product pages, as appropriate.

Tipo de dados

text

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0566251
Study conclusion
Descrição

Study conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008976
Date of subject completion or withdrawal
Descrição

day month year. If subject completed study: "Date of subject completion or withdrawal" must match the last scheduled study visit date. If subject withdrew and a withdrawal visit was conducted: "Date of subject completion or withdrawal" must match the date of subject withdrawal. If subject lost to follow-up: "Date of subject completion or withdrawal" must match the last actual contact with the subject whether or not the contact was a clinic visit. Do not record dates of unsuccessful attempts to contact the subject.

Tipo de dados

date

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

Withdrawn from study

Tipo de dados

text

Alias
UMLS CUI [1]
C0422727
If subject was withdrawn from study, please tick the primary reason for withdrawl
Descrição

If you tick 1: Record details on the Non-Serious Adverse Events or Serious Adverse Event pages as appropriate.

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0566251
If other reason for withdrawl, please specify
Descrição

Other reason for withdrawl

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C3840932
Pregnancy information
Descrição

Pregnancy information

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

X: not of childbearing potential or male If you tick yes, complete Pregnancy Notification form.

Tipo de dados

text

Alias
UMLS CUI [1]
C3828490
Investigator Comment Log
Descrição

Investigator Comment Log

Alias
UMLS CUI-1
C0008961
UMLS CUI-2
C0947611
CRF page number if applicable
Descrição

CRF page number

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C1704732
UMLS CUI [1,2]
C1516308
Comment
Descrição

Comment

Tipo de dados

text

Alias
UMLS CUI [1]
C0947611
Investigator's signature
Descrição

Investigator's signature

Alias
UMLS CUI-1
C2346576
Date of signature
Descrição

day month year

Tipo de dados

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Investigator's signature
Descrição

"I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below."

Tipo de dados

text

Alias
UMLS CUI [1]
C2346576
Investigator's name (print)
Descrição

Investigator's name

Tipo de dados

text

Alias
UMLS CUI [1]
C2826892
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Similar models

Status of treatment blind, study conclusion, pregnancy information, investigator's comment and signature

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Item Group
Status of treatment blind
C0749659 (UMLS CUI-1)
C2347038 (UMLS CUI-2)
Item
Was the treatment blind broken during the study?
text
C3897431 (UMLS CUI [1])
Treatment blind broken
Code List
Was the treatment blind broken during the study?
CL Item
Yes (Y)
CL Item
No (N)
Date blind broken
Item
Date blind broken
date
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time blind broken
Item
Time blind broken
time
C3897431 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Reason blind broken, tick one
integer
C3897431 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Reason blind broken
Code List
Reason blind broken, tick one
CL Item
Medical emergency requiring identification of investigational product for further treatment (1)
CL Item
Other (2)
Item
If other reason blind broken, please specify
text
C3897431 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Reason blind broken
Code List
If other reason blind broken, please specify
Item Group
Study conclusion
C1707478 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
Date of subject completion or withdrawal
Item
Date of subject completion or withdrawal
date
C2983670 (UMLS CUI [1])
Item
Was the subject withdrawn from the study?
text
C0422727 (UMLS CUI [1])
Withdrawn from study
Code List
Was the subject withdrawn from the study?
CL Item
Yes (Y)
CL Item
No (N)
Item
If subject was withdrawn from study, please tick the primary reason for withdrawl
integer
C0422727 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Withdrawn from study
Code List
If subject was withdrawn from study, please tick the primary reason for withdrawl
CL Item
Adverse event (1)
CL Item
Lost to follow-up (2)
CL Item
Protocol violation (3)
CL Item
Subject decided to withdraw from the study (4)
CL Item
Sponsor terminated study (5)
CL Item
Non-compliance (6)
CL Item
Other (7)
Other reason for withdrawl
Item
If other reason for withdrawl, please specify
text
C0422727 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
Item Group
Pregnancy information
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Item
Did the subject become pregnant during the study?
text
C3828490 (UMLS CUI [1])
Pregnancy during study
Code List
Did the subject become pregnant during the study?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not Applicable (X)
Item Group
Investigator Comment Log
C0008961 (UMLS CUI-1)
C0947611 (UMLS CUI-2)
CRF page number
Item
CRF page number if applicable
integer
C1704732 (UMLS CUI [1,1])
C1516308 (UMLS CUI [1,2])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Item Group
Investigator's signature
C2346576 (UMLS CUI-1)
Date of signature
Item
Date of signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator's signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])
Investigator's name
Item
Investigator's name (print)
text
C2826892 (UMLS CUI [1])
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