ID
39887
Beskrivning
Study ID: 110399 Clinical Study ID: 110399 Study Title: A randomized, double blind, parallel group, placebo controlled 28 day study to investigate the safety, tolerability and pharmacodynamics of SB-656933 in subjects with cystic fibrosis. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00903201 https://clinicaltrials.gov/ct2/show/NCT00903201?term=NCT00903201 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: SB656933, Placebo Trade Name: N/A Study Indication: Cystic Fibrosis The study consists of a screening, five study visits and a follow-up (time relative to Baseline in days): Visit 1: Screening, Day -28 to -16 Visit 2a: Day -7 to -4 Visit 2b: Day 1 Visit 3: Day 14 Visit 4: Day 21 Visit 5: Day 28 Visit 6: Early Withdrawal/ Follow-up, Day 35 to 42. From day 1 to day 28 the patients will receive daily doses. This document contains the pulmonary function test. It has to be filled in for screening, V2b, V3, V5, follow-up and if required for logs/ repeats.
Länk
https://clinicaltrials.gov/ct2/show/NCT00903201?term=NCT00903201
Nyckelord
Versioner (2)
- 2020-02-24 2020-02-24 -
- 2020-02-28 2020-02-28 - Sarah Riepenhausen
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
28 februari 2020
DOI
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Licens
Creative Commons BY-NC 4.0
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Safety, tolerability and pharmacodynamics of Elubrixin in cystic fibrosis patients, NCT00903201
Pulmonary function test
- StudyEvent: ODM
Beskrivning
Pulmonary function test
Alias
- UMLS CUI-1
- C0024119
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1]
- C2826247
Beskrivning
00:00-23:59
Datatyp
time
Alias
- UMLS CUI [1]
- C0429928
Beskrivning
For V2b fill in for both, pre- and post-bronchodilator. For V3, V5 and follow-up only fill in for pre-bronchodilator. This item has not to be filled in for screening and follow-up.
Datatyp
integer
Alias
- UMLS CUI [1]
- C0006280
Beskrivning
Pulmonary Function Test type
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0024119
- UMLS CUI [1,2]
- C0332307
Beskrivning
Please fill in three readings for both test types as well as for pre- and postbronchodilator.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0024119
- UMLS CUI [1,2]
- C0449788
- UMLS CUI [1,3]
- C0456984
Beskrivning
Pulmonary Function Test result
Datatyp
float
Måttenheter
- L
Alias
- UMLS CUI [1,1]
- C0456984
- UMLS CUI [1,2]
- C0024119
Beskrivning
Only to fill in for logs/ repeats.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1272696
- UMLS CUI [1,2]
- C0024119
Similar models
Pulmonary function test
- StudyEvent: ODM
C0332307 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,2])
C0456984 (UMLS CUI [1,3])
C0024119 (UMLS CUI [1,2])
C0024119 (UMLS CUI [1,2])
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