ID

34767

Description

Study ID: 115054 Clinical Study ID: 115054 Study Title: Ethanol-Free Clobetasol Propionate Foam 0.05% (Olux-E Foam) vs Vehicle Foam in the Treatment of Chronic Hand Dermatitis. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01323673 Sponsor: GlaxoSmithKline Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Vehicle / Placebo Trade Name: clobetasol propionate Study Indication: Dermatitis, Chronic

Keywords

Versions (1)
  1. 1/27/19 1/27/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 27, 2019

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Ethanol-Free Clobetasol Propionate Foam vs Vehicle Foam in Chronic Hand Dermatitis NCT01323673

English

Day 15/ Early Termination - Visit Date; Efficacy Assessments; Investigator Assessment; Subject Assessment; Vital Signs; End of Study

1 forms  
Visit Date
Description

Visit Date

Alias
UMLS CUI-1
C1320303
Date of visit
Description

Date of visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Or if visit Not Done, enter reason:
Description

Or if visit Not Done, enter reason:

Data type

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C2826287
Number of days from Baseline visit (derived)
Description

Number of days from Baseline visit (derived)

Data type

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1442488
UMLS CUI [1,3]
C0439228
UMLS CUI [1,4]
C0237753
Efficacy Assessments
Description

Efficacy Assessments

Alias
UMLS CUI-1
C1280519
UMLS CUI-2
C0220825
Has the subject used hand moisturizer since the last visit?
Description

Has the subject used hand moisturizer since the last visit?

Data type

boolean

Alias
UMLS CUI [1,1]
C3848663
UMLS CUI [1,2]
C0018563
Investigator Assessment
Description

Investigator Assessment

Investigator Static Global Assessment
Description

Investigator Static Global Assessment

Data type

integer

Alias
UMLS CUI [1]
C0450973
ISGA Assessor Name (First Initial, Last Name)
Description

ISGA Assessor Name

Data type

text

Alias
UMLS CUI [1,1]
C0401804
UMLS CUI [1,2]
C0027365
Subject Assessment
Description

Subject Assessment

Alias
UMLS CUI-1
C0681850
UMLS CUI-2
C0220825
Subject Global Assessment
Description

Subject Global Assessment

Data type

integer

Alias
UMLS CUI [1]
C0451514
Pruritus
Description

Pruritus

Data type

integer

Alias
UMLS CUI [1]
C0033774
Stinging
Description

Stinging

Data type

integer

Alias
UMLS CUI [1]
C0677500
Burning
Description

Burning

Data type

integer

Alias
UMLS CUI [1]
C0241057
Pain
Description

Pain

Data type

integer

Alias
UMLS CUI [1]
C0030193
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
Systolic BP (mmHg)
Description

Systolic BP (mmHg)

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic BP (mmHg)
Description

Diastolic BP (mmHg)

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Pulse (beats/minute)
Description

Pulse (beats/minute)

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0232117
beats/min
Temperature C
Description

Temperature C

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Temperature F
Description

Temperature F

Data type

float

Measurement units
  • F
Alias
UMLS CUI [1]
C0005903
F
End of Study
Description

End of Study

Alias
UMLS CUI-1
C0008972
UMLS CUI-2
C0444930
Date of Study Completion/ Termination
Description

Date of Study Completion/ Termination

Data type

date

Alias
UMLS CUI [1]
C4554101
Reason for Completion / Termination
Description

Reason for Completion / Termination

Data type

integer

Alias
UMLS CUI [1,1]
C1283212
UMLS CUI [1,2]
C0392360
If 'Other,' specify
Description

If 'Other,' specify

Data type

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C2348235
Fatal Outcome
Description

Fatal Outcome

Alias
UMLS CUI-1
C0206277
Date of Death
Description

Date of Death

Data type

date

Alias
UMLS CUI [1]
C1148348
Cause of Death
Description

Cause of Death

Data type

text

Alias
UMLS CUI [1]
C0007465
Back to the top of the page

Similar models

Day 15/ Early Termination - Visit Date; Efficacy Assessments; Investigator Assessment; Subject Assessment; Vital Signs; End of Study

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Visit Date
C1320303 (UMLS CUI-1)
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Or if visit Not Done, enter reason:
Item
Or if visit Not Done, enter reason:
text
C0545082 (UMLS CUI [1,1])
C2826287 (UMLS CUI [1,2])
Number of days from Baseline visit (derived)
Item
Number of days from Baseline visit (derived)
integer
C0545082 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,4])
Item Group
Efficacy Assessments
C1280519 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
Has the subject used hand moisturizer since the last visit?
Item
Has the subject used hand moisturizer since the last visit?
boolean
C3848663 (UMLS CUI [1,1])
C0018563 (UMLS CUI [1,2])
Item Group
Investigator Assessment
Item
Investigator Static Global Assessment
integer
C0450973 (UMLS CUI [1])
Investigator Static Global Assessment
Code List
Investigator Static Global Assessment
CL Item
Clear - Minor residual discoloration, no erythema or induration/papulation, no oozing/crusting (0)
CL Item
Almost Clear - May be trace faint pink erythema, w/ almost no induration/papulation and no oozing/crusting (1)
CL Item
Mild - May be faint erythema w/ mild induration/papulation and no oozing/crusting (2)
CL Item
Moderate - May be pink-red erythema w/ moderate induration/papulation and some oozing/crusting (3)
CL Item
Severe - May be deep or bright red erythema w/ severe induration/papulation and w/ oozing/crusting (4)
ISGA Assessor Name
Item
ISGA Assessor Name (First Initial, Last Name)
text
C0401804 (UMLS CUI [1,1])
C0027365 (UMLS CUI [1,2])
Item Group
Subject Assessment
C0681850 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
Item
Subject Global Assessment
integer
C0451514 (UMLS CUI [1])
Subject Global Assessment
Code List
Subject Global Assessment
CL Item
My skin is clear (0)
CL Item
My dermatitis is minimal, maybe a few light pink areas (1)
CL Item
My dermatitis is mild, maybe occasional light pink areas (2)
CL Item
My dermatitis is moderate, easily noticeable pink-red areas (3)
CL Item
My dermatitis is severe, deep or bright red areas which may be warm when touched (4)
Item
Pruritus
integer
C0033774 (UMLS CUI [1])
Pruritus
Code List
Pruritus
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
CL Item
7 (7)
CL Item
8 (8)
CL Item
9 (9)
CL Item
10 (10)
Item
Stinging
integer
C0677500 (UMLS CUI [1])
Stinging
Code List
Stinging
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
CL Item
7 (7)
CL Item
8 (8)
CL Item
9 (9)
CL Item
10 (10)
Item
Burning
integer
C0241057 (UMLS CUI [1])
Burning
Code List
Burning
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
CL Item
7 (7)
CL Item
8 (8)
CL Item
9 (9)
CL Item
10 (10)
Item
Pain
integer
C0030193 (UMLS CUI [1])
Pain
Code List
Pain
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
CL Item
7 (7)
CL Item
8 (8)
CL Item
9 (9)
CL Item
10 (10)
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Systolic BP (mmHg)
Item
Systolic BP (mmHg)
integer
C0871470 (UMLS CUI [1])
Diastolic BP (mmHg)
Item
Diastolic BP (mmHg)
integer
C0428883 (UMLS CUI [1])
Pulse (beats/minute)
Item
Pulse (beats/minute)
integer
C0232117 (UMLS CUI [1])
Temperature C
Item
Temperature C
float
C0005903 (UMLS CUI [1])
Temperature F
Item
Temperature F
float
C0005903 (UMLS CUI [1])
Item Group
End of Study
C0008972 (UMLS CUI-1)
C0444930 (UMLS CUI-2)
Date of Study Completion/ Termination
Item
Date of Study Completion/ Termination
date
C4554101 (UMLS CUI [1])
Item
Reason for Completion / Termination
integer
C1283212 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Reason for Completion / Termination
Code List
Reason for Completion / Termination
CL Item
Completed (1)
CL Item
Adverse Event (2)
CL Item
Lost to Follow up (3)
CL Item
Non- compliance with Study Treatment (4)
CL Item
Withdrawal of Consent (5)
CL Item
Disease Progression/ Lack of Efficacy (6)
CL Item
Death (7)
CL Item
Other (8)
If 'Other,' specify
Item
If 'Other,' specify
text
C0205394 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Item Group
Fatal Outcome
C0206277 (UMLS CUI-1)
Date of Death
Item
Date of Death
date
C1148348 (UMLS CUI [1])
Cause of Death
Item
Cause of Death
text
C0007465 (UMLS CUI [1])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial