ID
34844
Beskrivning
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.
Nyckelord
Versioner (3)
- 2019-01-29 2019-01-29 -
- 2019-01-29 2019-01-29 -
- 2019-01-31 2019-01-31 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
31 januari 2019
DOI
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Licens
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
Status of treatment blind, study conclusion, pregnancy information, investigator's comment and signature
Beskrivning
Status of treatment blind
Alias
- UMLS CUI-1
- C0749659
- UMLS CUI-2
- C2347038
Beskrivning
If Yes, complete the following items.
Datatyp
text
Alias
- UMLS CUI [1]
- C3897431
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0011008
Beskrivning
00:00-23:59
Datatyp
time
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0040223
Beskrivning
Complete Non-Serious Adverse Events, Serious Adverse Event and/or lnvestigational Product pages, as appropriate.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0566251
Beskrivning
Complete Non-Serious Adverse Events, Serious Adverse Event and/or lnvestigational Product pages, as appropriate.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0566251
Beskrivning
Study conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008976
Beskrivning
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.
Datatyp
date
Alias
- UMLS CUI [1]
- C2983670
Beskrivning
Withdrawn from study
Datatyp
text
Alias
- UMLS CUI [1]
- C0422727
Beskrivning
If you tick 1: Record details on the Non-Serious Adverse Events or Serious Adverse Event pages as appropriate.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0566251
Beskrivning
Other reason for withdrawl
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C3840932
Beskrivning
Pregnancy information
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C1533716
Beskrivning
Investigator Comment Log
Alias
- UMLS CUI-1
- C0008961
- UMLS CUI-2
- C0947611
Beskrivning
Investigator's signature
Alias
- UMLS CUI-1
- C2346576
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beskrivning
"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."
Datatyp
text
Alias
- UMLS CUI [1]
- C2346576
Beskrivning
Investigator's name
Datatyp
text
Alias
- UMLS CUI [1]
- C2826892
Similar models
Status of treatment blind, study conclusion, pregnancy information, investigator's comment and signature
C2347038 (UMLS CUI-2)
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,2])
C3840932 (UMLS CUI [1,2])
C0947611 (UMLS CUI-2)
C1516308 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])