ID
39860
Beschrijving
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
Trefwoorden
Versies (2)
- 19-02-20 19-02-20 -
- 24-02-20 24-02-20 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
24 februari 2020
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 4.0
Model Commentaren :
Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.
Itemgroep Commentaren voor :
Item Commentaren voor :
U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.
Safety, tolerability and pharmacodynamics of Elubrixin in cystic fibrosis patients, NCT00903201
Investigational product, Randomisation Number
- StudyEvent: ODM
Beschrijving
Randomisation Number
Alias
- UMLS CUI-1
- C0034656
- UMLS CUI-2
- C0237753
Beschrijving
Investigational product container number
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0180098
- UMLS CUI-3
- C0600091
Beschrijving
Fill in for both numbers the container label in the following item.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0180098
- UMLS CUI [1,3]
- C0237753
Beschrijving
Container Label
Datatype
text
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0180098
- UMLS CUI [1,3]
- C0600091
Beschrijving
Investigational product (Dose)
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0678766
Beschrijving
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.
Datatype
integer
Alias
- UMLS CUI [1]
- C0439228
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0011008
Beschrijving
00:00-23:59
Datatype
time
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0040223
Beschrijving
Correct treatment during dosing interval
Datatype
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
Beschrijving
No correct treatment, reason
Datatype
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C1298908
- UMLS CUI [1,3]
- C0087111
- UMLS CUI [1,4]
- C2349182
Beschrijving
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
Beschrijving
Day
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0439228
- UMLS CUI [1,2]
- C0205103
- UMLS CUI [1,3]
- C0545082
- UMLS CUI [1,4]
- C2603343
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0808070
Beschrijving
00:00-23:59
Datatype
time
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C1301880
Beschrijving
Correct treatment during dosing interval
Datatype
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
Beschrijving
No correct treatment, reason
Datatype
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])