ID
33703
Beskrivning
Study ID: 102936 Clinical Study ID: HZA102936 Study Title:A randomised, placebo-controlled, four-way crossover repeat dose study to evaluate the effect of the inhaled fluticasone furoate (FF)/GW642444M combination on electrocardiographic parameters, with moxifloxacin as a positive control, in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01209026 https://clinicaltrials.gov/ct2/show/NCT01209026?term=NCT01209026 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: Allermist,Veramyst,Avamys; Veramyst,Avamys,Allermist Study Indication: Asthma The study consists of a screening, 8 treatment periods and a follow up. Treatment periods 1-4 are each 7 days long. Treatment period 1 Days 1-6 (TP1D-D6) Treatment period 1 Day 7 (TP1D7) Treatment period 2 Days 1-6 (TP2D1-D6) Treatment period 2 Day 7 (TP2D7) Treatment period 3 Days 1-6 (TP3D1-D6) Treatment period 3 Day 7 (TP3D7) Treatment period 4 Days 1-6 (TP4D1-D6) Treatment period 4 Day 7 (TP4D7) This document contains the study conclusion form and the pregnancy information. It has to be filled in for the end of study.
Länk
https://clinicaltrials.gov/ct2/show/NCT01209026?term=NCT01209026
Nyckelord
Versioner (2)
- 2018-12-20 2018-12-20 -
- 2018-12-20 2018-12-20 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
20 december 2018
DOI
För en begäran logga in.
Licens
Creative Commons BY-NC 3.0
Modellkommentarer :
Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.
Itemgroup-kommentar för :
Item-kommentar för :
Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.
Effect of inhaled fluticasone furoate/Vilanterol combination on electrocardiographic parameters in healthy subjects, NCT01209026
Study conclusion, pregnancy information
- StudyEvent: ODM
Beskrivning
Study conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008972
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1]
- C0805839
Beskrivning
If yes complete the following items for withdrawing information
Datatyp
text
Alias
- UMLS CUI [1]
- C0422727
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0679006
- UMLS CUI [1,3]
- C0011008
Beskrivning
If you tick 1: Record details on the Non-Serious Adverse Events or Serious Adverse Events forms as appropriate. To 5: Select this reason if none of the other primary reasons are appropriate. 5, 7 and 8 are optional.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C1549995
Beskrivning
Investigator discretion
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0008961
- UMLS CUI [1,2]
- C0022423
Beskrivning
Data owner should check the box when data cleaning is complete. Item Is not required
Datatyp
text
Alias
- UMLS CUI [1]
- C1519316
Beskrivning
Office Use 1
Datatyp
text
Alias
- UMLS CUI [1]
- C0442603
Beskrivning
Office Use 2
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0442603
- UMLS CUI [1,2]
- C0237753
Beskrivning
Pregnancy information
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C1533716
Beskrivning
For females. If Yes, complete the paper Pregnancy Notification form
Datatyp
text
Alias
- UMLS CUI [1]
- C3828490
Beskrivning
For males. If Yes, complete the paper Pregnancy Notification form. Check Not Applicable if female partner not of childbearing potential or no female partner.
Datatyp
text
Alias
- UMLS CUI [1]
- C3828490
- UMLS CUI [2,1]
- C0919624
- UMLS CUI [2,2]
- C0086287
Similar models
Study conclusion, pregnancy information
- StudyEvent: ODM
C0679006 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1549995 (UMLS CUI [1,2])
C0022423 (UMLS CUI [1,2])
C0919624 (UMLS CUI [2,1])
C0086287 (UMLS CUI [2,2])