ID
34931
Beschrijving
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 12-lead ECG form. It has to be filled in for screening, TP1-4 Day-1 anf for follow-up.
Trefwoorden
Versies (1)
- 04-02-19 04-02-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
4 februari 2019
DOI
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Licentie
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
12-lead ECG for screening, TP1-4 Day-1 and for follow-up
- StudyEvent: ODM
Beschrijving
12-LEAD ECG
Alias
- UMLS CUI-1
- C0430456
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0808070
Beschrijving
Three measurements will be taken at each specified time. screening and unscheduled: for screening visit day-1 and unscheduled: for treatment periods day-1 follow-up and unscheduled: for follow-up
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0439564
- UMLS CUI [1,2]
- C0430456
Beschrijving
00:00-23:59
Datatype
time
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1301880
Beschrijving
Ventricular Rate
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1]
- C2189285
Beschrijving
PR Interval
Datatype
integer
Maateenheden
- msec
Alias
- UMLS CUI [1]
- C0429087
Beschrijving
QRS Duration
Datatype
integer
Maateenheden
- msec
Alias
- UMLS CUI [1]
- C0429025
Beschrijving
Uncorrected QT Interval
Datatype
integer
Maateenheden
- msec
Alias
- UMLS CUI [1]
- C1287082
Beschrijving
QTc Interval
Datatype
integer
Maateenheden
- msec
Alias
- UMLS CUI [1]
- C0855331
Beschrijving
Not for screening visit.
Datatype
integer
Maateenheden
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1882513
Beschrijving
Not for screening visit. If a subject’s QTcF interval extends beyond 500msec or is increased more than 60msec compared to baseline (confirmed on three or more ECG tracings separated by at least 2 minutes), the ECG tracing should be examined by an appropriately trained physician and manual measurements undertaken. If the reading is confirmed, the subject should be closely monitored and followed in the clinical unit until the QT and QTc(F) interval return to within 30msec of their baseline.
Datatype
integer
Maateenheden
- msec
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C2911685
- UMLS CUI [1,3]
- C0175674
Beschrijving
enter code for result from the following list. If you tick 'Abnormal-clinically significant': Complete the Serious Adverse Event (SAE) page(s) if clinically significant abnormalities meet the protocol definition for a SAE. Complete the additional ECG Abnormalities page if clinically significant abnormalities are present.
Datatype
integer
Alias
- UMLS CUI [1]
- C0438154
Similar models
12-lead ECG for screening, TP1-4 Day-1 and for follow-up
- StudyEvent: ODM
C0808070 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
C1882513 (UMLS CUI [1,2])
C2911685 (UMLS CUI [1,2])
C0175674 (UMLS CUI [1,3])