ID
34931
Beschreibung
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.
Stichworte
Versionen (1)
- 04.02.19 04.02.19 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
4. Februar 2019
DOI
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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
Beschreibung
12-LEAD ECG
Alias
- UMLS CUI-1
- C0430456
Beschreibung
day month year
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0808070
Beschreibung
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
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0439564
- UMLS CUI [1,2]
- C0430456
Beschreibung
00:00-23:59
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1301880
Beschreibung
Ventricular Rate
Datentyp
integer
Maßeinheiten
- beats/min
Alias
- UMLS CUI [1]
- C2189285
Beschreibung
PR Interval
Datentyp
integer
Maßeinheiten
- msec
Alias
- UMLS CUI [1]
- C0429087
Beschreibung
QRS Duration
Datentyp
integer
Maßeinheiten
- msec
Alias
- UMLS CUI [1]
- C0429025
Beschreibung
Uncorrected QT Interval
Datentyp
integer
Maßeinheiten
- msec
Alias
- UMLS CUI [1]
- C1287082
Beschreibung
QTc Interval
Datentyp
integer
Maßeinheiten
- msec
Alias
- UMLS CUI [1]
- C0855331
Beschreibung
Not for screening visit.
Datentyp
integer
Maßeinheiten
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1882513
Beschreibung
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.
Datentyp
integer
Maßeinheiten
- msec
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C2911685
- UMLS CUI [1,3]
- C0175674
Beschreibung
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.
Datentyp
integer
Alias
- UMLS CUI [1]
- C0438154
Ähnliche Modelle
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])