ID

39860

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 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

Keywords

Versions (2)
  1. 2/19/20 2/19/20 -
  2. 2/24/20 2/24/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

February 24, 2020

DOI

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License

Creative Commons BY-NC 4.0
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Safety, tolerability and pharmacodynamics of Elubrixin in cystic fibrosis patients, NCT00903201

English

Investigational product, Randomisation Number

1 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Date of Visit
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C1320303
Visit type
Description

Please note for which visit you will fill in this document. For Visit 5 only the itemgroup "Investigational product (Dose)" has to be filled in.

Data type

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Randomisation Number
Description

Randomisation Number

Alias
UMLS CUI-1
C0034656
UMLS CUI-2
C0237753
Was the subject able to be randomised?
Description

Randomisation of subject

Data type

text

Alias
UMLS CUI [1]
C0034656
If subject was able to be randomised, please provide the randomisation number
Description

Randomisation Number

Data type

text

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Investigational product container number
Description

Investigational product container number

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0180098
UMLS CUI-3
C0600091
Investigational product container number
Description

Fill in for both numbers the container label in the following item.

Data type

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0180098
UMLS CUI [1,3]
C0237753
Container Label
Description

Container Label

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0180098
UMLS CUI [1,3]
C0600091
Investigational product (Dose)
Description

Investigational product (Dose)

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0678766
Day
Description

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.

Data type

integer

Alias
UMLS CUI [1]
C0439228
Date of dose
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
Time of dose
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0040223
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
Description

Correct treatment during dosing interval

Data type

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
If subject did not receive the correct treatment, please record reason(s)
Description

No correct treatment, reason

Data type

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C1298908
UMLS CUI [1,3]
C0087111
UMLS CUI [1,4]
C2349182
Investigational product (Dose between study visits)
Description

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
Day (between study visits)
Description

Day

Data type

integer

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C0205103
UMLS CUI [1,3]
C0545082
UMLS CUI [1,4]
C2603343
Start Date of dose
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0808070
Start Time of dose
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1301880
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
Description

Correct treatment during dosing interval

Data type

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
If subject did not receive the correct treatment, please record reason(s)
Description

No correct treatment, reason

Data type

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C1298908
UMLS CUI [1,3]
C0087111
UMLS CUI [1,4]
C2349182
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Similar models

Investigational product, Randomisation Number

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Item
Visit type
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Visit type
Code List
Visit type
CL Item
V2b (1)
CL Item
V3 (2)
CL Item
V4 (3)
CL Item
V5 (4)
Item Group
Randomisation Number
C0034656 (UMLS CUI-1)
C0237753 (UMLS CUI-2)
Item
Was the subject able to be randomised?
text
C0034656 (UMLS CUI [1])
Correct treatment during dosing interval
Code List
Was the subject able to be randomised?
CL Item
Yes (Y)
CL Item
No (N)
Randomisation Number
Item
If subject was able to be randomised, please provide the randomisation number
text
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item Group
Investigational product container number
C0304229 (UMLS CUI-1)
C0180098 (UMLS CUI-2)
C0600091 (UMLS CUI-3)
Item
Investigational product container number
integer
C0304229 (UMLS CUI [1,1])
C0180098 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Investigational product container number
Code List
Investigational product container number
CL Item
1 (1)
CL Item
2 (2)
Item
Container Label
text
C0304229 (UMLS CUI [1,1])
C0180098 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Container Label
Code List
Container Label
CL Item
Bottle A (A)
CL Item
Bottle B (B)
Item Group
Investigational product (Dose)
C0304229 (UMLS CUI-1)
C0678766 (UMLS CUI-2)
Item
Day
integer
C0439228 (UMLS CUI [1])
Day
Code List
Day
CL Item
Day 1 (1)
CL Item
Day 14 (2)
CL Item
Day 21 (3)
CL Item
Day 28 (4)
Date of dose, Experimental Drug
Item
Date of dose
date
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Time of dose, Experimental Drug
Item
Time of dose
time
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
text
C0087111 (UMLS CUI [1,1])
C2349182 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,4])
C1272706 (UMLS CUI [1,5])
Correct treatment during dosing interval
Code List
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
CL Item
Yes (Y)
CL Item
No (N)
No correct treatment, reason
Item
If subject did not receive the correct treatment, please record reason(s)
text
C0392360 (UMLS CUI [1,1])
C1298908 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C2349182 (UMLS CUI [1,4])
Item Group
Investigational product (Dose between study visits)
C0304229 (UMLS CUI-1)
C0678766 (UMLS CUI-2)
C0205103 (UMLS CUI-3)
C0545082 (UMLS CUI-4)
C2603343 (UMLS CUI-5)
Item
Day (between study visits)
integer
C0439228 (UMLS CUI [1,1])
C0205103 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
C2603343 (UMLS CUI [1,4])
Day
Code List
Day (between study visits)
CL Item
Day 2 (1)
CL Item
Day 3 (2)
CL Item
Day 4 (3)
CL Item
Day 5 (4)
CL Item
Day 6 (5)
CL Item
Day 7 (6)
CL Item
Day 8 (7)
CL Item
Day 9 (8)
CL Item
Day 10 (9)
CL Item
Day 11 (10)
CL Item
Day 12 (11)
CL Item
Day 13 (12)
CL Item
Day 15 (13)
CL Item
Day 16 (14)
CL Item
Day 17 (15)
CL Item
Day 18 (16)
CL Item
Day 19 (17)
CL Item
Day 20 (18)
CL Item
Day 22 (19)
CL Item
Day 23 (20)
CL Item
Day 24 (21)
CL Item
Day 25 (22)
CL Item
Day 26 (23)
CL Item
Day 27 (24)
Start Date of dose, Experimental Drug
Item
Start Date of dose
date
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Start Time of dose, Experimental Drug
Item
Start Time of dose
time
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Item
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
text
C0087111 (UMLS CUI [1,1])
C2349182 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,4])
C1272706 (UMLS CUI [1,5])
Correct treatment during dosing interval
Code List
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
CL Item
Yes (Y)
CL Item
No (N)
No correct treatment, reason
Item
If subject did not receive the correct treatment, please record reason(s)
text
C0392360 (UMLS CUI [1,1])
C1298908 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C2349182 (UMLS CUI [1,4])
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