ID
39860
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 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
Stichworte
Versionen (2)
- 19.02.20 19.02.20 -
- 24.02.20 24.02.20 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
24. 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
Investigational product, Randomisation Number
- StudyEvent: ODM
Beschreibung
Randomisation Number
Alias
- UMLS CUI-1
- C0034656
- UMLS CUI-2
- C0237753
Beschreibung
Investigational product container number
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0180098
- UMLS CUI-3
- C0600091
Beschreibung
Fill in for both numbers the container label in the following item.
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0180098
- UMLS CUI [1,3]
- C0237753
Beschreibung
Container Label
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0180098
- UMLS CUI [1,3]
- C0600091
Beschreibung
Investigational product (Dose)
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0678766
Beschreibung
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.
Datentyp
integer
Alias
- UMLS CUI [1]
- C0439228
Beschreibung
day month year
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0011008
Beschreibung
00:00-23:59
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0040223
Beschreibung
Correct treatment during dosing interval
Datentyp
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
Beschreibung
No correct treatment, reason
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C1298908
- UMLS CUI [1,3]
- C0087111
- UMLS CUI [1,4]
- C2349182
Beschreibung
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
Beschreibung
Day
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0439228
- UMLS CUI [1,2]
- C0205103
- UMLS CUI [1,3]
- C0545082
- UMLS CUI [1,4]
- C2603343
Beschreibung
day month year
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0808070
Beschreibung
00:00-23:59
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C1301880
Beschreibung
Correct treatment during dosing interval
Datentyp
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
Beschreibung
No correct treatment, reason
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C1298908
- UMLS CUI [1,3]
- C0087111
- UMLS CUI [1,4]
- C2349182
Ähnliche Modelle
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])