ID
39887
Beschreibung
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.
Link
https://clinicaltrials.gov/ct2/show/NCT00903201?term=NCT00903201
Stichworte
Versionen (2)
- 24.02.20 24.02.20 -
- 28.02.20 28.02.20 - Sarah Riepenhausen
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
28. Februar 2020
DOI
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Lizenz
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
Beschreibung
Pulmonary function test
Alias
- UMLS CUI-1
- C0024119
Beschreibung
day month year
Datentyp
date
Alias
- UMLS CUI [1]
- C2826247
Beschreibung
00:00-23:59
Datentyp
time
Alias
- UMLS CUI [1]
- C0429928
Beschreibung
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.
Datentyp
integer
Alias
- UMLS CUI [1]
- C0006280
Beschreibung
Pulmonary Function Test type
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0024119
- UMLS CUI [1,2]
- C0332307
Beschreibung
Please fill in three readings for both test types as well as for pre- and postbronchodilator.
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0024119
- UMLS CUI [1,2]
- C0449788
- UMLS CUI [1,3]
- C0456984
Beschreibung
Pulmonary Function Test result
Datentyp
float
Maßeinheiten
- L
Alias
- UMLS CUI [1,1]
- C0456984
- UMLS CUI [1,2]
- C0024119
Beschreibung
Only to fill in for logs/ repeats.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1272696
- UMLS CUI [1,2]
- C0024119
Ähnliche Modelle
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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