ID
39860
Descripción
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 Investigational product form. It has to be filled in for V2b, V3, V4 and V5. The document also contains the Randomisation Number form. It has to be filled in for V2b.
Link
https://clinicaltrials.gov/ct2/show/NCT00903201?term=NCT00903201
Palabras clave
Versiones (2)
- 19/2/20 19/2/20 -
- 24/2/20 24/2/20 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
24 de febrero de 2020
DOI
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Licencia
Creative Commons BY-NC 4.0
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Safety, tolerability and pharmacodynamics of Elubrixin in cystic fibrosis patients, NCT00903201
Investigational product, Randomisation Number
- StudyEvent: ODM
Descripción
Randomisation Number
Alias
- UMLS CUI-1
- C0034656
- UMLS CUI-2
- C0237753
Descripción
Randomisation of subject
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0034656
Descripción
Randomisation Number
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0237753
Descripción
Investigational product container number
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0180098
- UMLS CUI-3
- C0600091
Descripción
Fill in for both numbers the container label in the following item.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0180098
- UMLS CUI [1,3]
- C0237753
Descripción
Container Label
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0180098
- UMLS CUI [1,3]
- C0600091
Descripción
Investigational product (Dose)
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0678766
Descripción
Day 1 has to be filled in for V2b. Day 14 has to be filled in for V3. Day 21 has to be filled in for V4. Day 28 has to be filled in for V5.
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0439228
Descripción
day month year
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0011008
Descripción
00:00-23:59
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0040223
Descripción
Correct treatment during dosing interval
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0087111
- UMLS CUI [1,2]
- C2349182
- UMLS CUI [1,3]
- C0347984
- UMLS CUI [1,4]
- C0178602
- UMLS CUI [1,5]
- C1272706
Descripción
No correct treatment, reason
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C1298908
- UMLS CUI [1,3]
- C0087111
- UMLS CUI [1,4]
- C2349182
Descripción
Investigational product (Dose between study visits)
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0678766
- UMLS CUI-3
- C0205103
- UMLS CUI-4
- C0545082
- UMLS CUI-5
- C2603343
Descripción
Day
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0439228
- UMLS CUI [1,2]
- C0205103
- UMLS CUI [1,3]
- C0545082
- UMLS CUI [1,4]
- C2603343
Descripción
day month year
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0808070
Descripción
00:00-23:59
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C1301880
Descripción
Correct treatment during dosing interval
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0087111
- UMLS CUI [1,2]
- C2349182
- UMLS CUI [1,3]
- C0347984
- UMLS CUI [1,4]
- C0178602
- UMLS CUI [1,5]
- C1272706
Descripción
No correct treatment, reason
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C1298908
- UMLS CUI [1,3]
- C0087111
- UMLS CUI [1,4]
- C2349182
Similar models
Investigational product, Randomisation Number
- StudyEvent: ODM
C0237753 (UMLS CUI [1,2])
C0180098 (UMLS CUI-2)
C0600091 (UMLS CUI-3)
C0180098 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
C0180098 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
C0678766 (UMLS CUI-2)
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C2349182 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,4])
C1272706 (UMLS CUI [1,5])
C1298908 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C2349182 (UMLS CUI [1,4])
C0678766 (UMLS CUI-2)
C0205103 (UMLS CUI-3)
C0545082 (UMLS CUI-4)
C2603343 (UMLS CUI-5)
C0205103 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
C2603343 (UMLS CUI [1,4])
C0178602 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
C2349182 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,4])
C1272706 (UMLS CUI [1,5])
C1298908 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C2349182 (UMLS CUI [1,4])