ID
34844
Descripción
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.
Palabras clave
Versiones (3)
- 29/1/19 29/1/19 -
- 29/1/19 29/1/19 -
- 31/1/19 31/1/19 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
31 de enero de 2019
DOI
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Licencia
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
Descripción
Status of treatment blind
Alias
- UMLS CUI-1
- C0749659
- UMLS CUI-2
- C2347038
Descripción
If Yes, complete the following items.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C3897431
Descripción
day month year
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0011008
Descripción
00:00-23:59
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0040223
Descripción
Complete Non-Serious Adverse Events, Serious Adverse Event and/or lnvestigational Product pages, as appropriate.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0566251
Descripción
Complete Non-Serious Adverse Events, Serious Adverse Event and/or lnvestigational Product pages, as appropriate.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0566251
Descripción
Study conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008976
Descripción
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 datos
date
Alias
- UMLS CUI [1]
- C2983670
Descripción
Withdrawn from study
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0422727
Descripción
If you tick 1: Record details on the Non-Serious Adverse Events or Serious Adverse Event pages as appropriate.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0566251
Descripción
Other reason for withdrawl
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C3840932
Descripción
Pregnancy information
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C1533716
Descripción
Investigator Comment Log
Alias
- UMLS CUI-1
- C0008961
- UMLS CUI-2
- C0947611
Descripción
Investigator's signature
Alias
- UMLS CUI-1
- C2346576
Descripción
day month year
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Descripción
"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 datos
text
Alias
- UMLS CUI [1]
- C2346576
Descripción
Investigator's name
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2826892
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Status of treatment blind, study conclusion, pregnancy information, investigator's comment and signature
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