ID
39731
Description
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 demography form. It has to be filled in for screening.
Link
https://clinicaltrials.gov/ct2/show/NCT00903201?term=NCT00903201
Keywords
Versions (1)
- 2/14/20 2/14/20 -
Copyright Holder
GlaxoSmithKline
Uploaded on
February 14, 2020
DOI
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License
Creative Commons BY-NC 3.0
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Safety, tolerability and pharmacodynamics of Elubrixin in cystic fibrosis patients, NCT00903201
Demography
- StudyEvent: ODM
Description
Demography
Alias
- UMLS CUI-1
- C0011298
Description
day month year. Enter subject's date of birth, if you unable to provide a full date of birth, enter a partial date of birth.
Data type
partialDate
Alias
- UMLS CUI [1]
- C0421451
Description
Sex
Data type
text
Alias
- UMLS CUI [1]
- C0079399
Description
Child-bearing potential
Data type
integer
Alias
- UMLS CUI [1]
- C3831118
Description
Ethnicity
Data type
integer
Alias
- UMLS CUI [1]
- C0015031
Description
Geographic ancestry
Alias
- UMLS CUI-1
- C0034510
Description
African American/African Heritage
Data type
boolean
Alias
- UMLS CUI [1]
- C0085756
- UMLS CUI [2]
- C0027567
Description
American Indian or Alaskan Native
Data type
boolean
Alias
- UMLS CUI [1]
- C1515945
Description
Asian - Central/South Asian Heritage
Data type
boolean
Alias
- UMLS CUI [1]
- C0238696
- UMLS CUI [2]
- C1519427
Description
Asian - East Asian Heritage
Data type
boolean
Alias
- UMLS CUI [1]
- C4540996
Description
Asian - Japanese Heritage
Data type
boolean
Alias
- UMLS CUI [1]
- C1556094
Description
Asian - South East Asian Heritage
Data type
boolean
Alias
- UMLS CUI [1]
- C0238697
Description
Native Hawaiian or Other Pacific Islander
Data type
boolean
Alias
- UMLS CUI [1]
- C1513907
Description
White - Arabic/North African Heritage
Data type
boolean
Alias
- UMLS CUI [1]
- C0238604
- UMLS CUI [2]
- C2698217
Description
White - White/Caucasian/European Heritage
Data type
boolean
Alias
- UMLS CUI [1]
- C0043157
Similar models
Demography
- StudyEvent: ODM
C2985720 (UMLS CUI [2])
C0027567 (UMLS CUI [2])
C1519427 (UMLS CUI [2])
C2698217 (UMLS CUI [2])