ID

34769

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

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License

Creative Commons BY-NC 3.0
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Ethanol-Free Clobetasol Propionate Foam vs Vehicle Foam in Chronic Hand Dermatitis NCT01323673

English

Subject Enrollment; Study Product Accountability; Study Product Usage; Photographs

1 forms  
Subject Enrollment
Description

Subject Enrollment

Alias
UMLS CUI-1
C1516879
Subject Number
Description

Enter the 4-digit subject number as assigned.

Data type

integer

Alias
UMLS CUI [1]
C2348585
Subject ID
Description

Subject ID

Data type

integer

Alias
UMLS CUI [1]
C2348585
Age at BSL visit for QoL addition (derived)
Description

Age at BSL visit for QoL addition (derived)

Data type

integer

Alias
UMLS CUI [1]
C0001779
Study Product Accountability
Description

Study Product Accountability

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0078889
Container Number
Description

Container Number

Data type

integer

Alias
UMLS CUI [1,1]
C0180098
UMLS CUI [1,2]
C0600091
Date of Assessment
Description

Date of Assessment

Data type

date

Alias
UMLS CUI [1]
C2985720
Status
Description

Status

Data type

integer

Alias
UMLS CUI [1]
C0449438
Weight
Description

Weight

Data type

integer

Alias
UMLS CUI [1]
C0043100
Study Product Usage
Description

Study Product Usage

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0457083
Date of First Study Treatment
Description

Date of First Study Treatment

Data type

date

Alias
UMLS CUI [1]
C3173309
Please indicate if the first dose was a morning (AM) or evening (PM) dose
Description

Please indicate if the first dose was a morning (AM) or evening (PM) dose

Data type

integer

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0205435
UMLS CUI [1,3]
C0040223
Date of Last Study Treatment (If date of last study treatment is not certain, enter the last known date of treatment)
Description

Date of Last Study Treatment

Data type

date

Alias
UMLS CUI [1]
C1531784
Please indicate if the last dose was a morning (AM) or evening (PM) dose
Description

Please indicate if the last dose was a morning (AM) or evening (PM) dose

Data type

integer

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C0040223
Between the Date of First Study Treatment and the Date of Last Study Treatment, has the subject missed any study product applications as specified in the protocol?
Description

If YES , please record the date of each missed study treatment below. Add a new record for each missed treatment.

Data type

boolean

Alias
UMLS CUI [1]
C1709043
Date of Missed Treatment
Description

Date of Missed Treatment

Data type

date

Alias
UMLS CUI [1,1]
C1709043
UMLS CUI [1,2]
C0011008
Check if AM treatment missed
Description

Check if AM treatment missed

Data type

integer

Alias
UMLS CUI [1,1]
C1709043
UMLS CUI [1,2]
C4331833
Check if PM treatment missed
Description

Check if PM treatment missed

Data type

integer

Alias
UMLS CUI [1,1]
C1709043
UMLS CUI [1,2]
C1509133
Photographs
Description

Photographs

Alias
UMLS CUI-1
C0441468
If consent to photographs was not given, please check box:
Description

If consent to photographs was not given, please check box:

Data type

integer

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0441468
Visit
Description

Visit

Data type

integer

Alias
UMLS CUI [1]
C0545082
Date of Photograph
Description

Date of Photograph

Data type

date

Alias
UMLS CUI [1,1]
C0441468
UMLS CUI [1,2]
C0011008
Or check if Photograph Not Done
Description

Or check if Photograph Not Done

Data type

integer

Alias
UMLS CUI [1,1]
C0441468
UMLS CUI [1,2]
C1272696
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Similar models

Subject Enrollment; Study Product Accountability; Study Product Usage; Photographs

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Subject Enrollment
C1516879 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Subject ID
Item
Subject ID
integer
C2348585 (UMLS CUI [1])
Age at BSL visit for QoL addition (derived)
Item
Age at BSL visit for QoL addition (derived)
integer
C0001779 (UMLS CUI [1])
Item Group
Study Product Accountability
C0304229 (UMLS CUI-1)
C0078889 (UMLS CUI-2)
Container Number
Item
Container Number
integer
C0180098 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Date of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
Item
Status
integer
C0449438 (UMLS CUI [1])
Status
Code List
Status
CL Item
Dispensed (1)
CL Item
Re- dispensed (2)
CL Item
Collected (3)
CL Item
Lost (4)
Weight
Item
Weight
integer
C0043100 (UMLS CUI [1])
Item Group
Study Product Usage
C0304229 (UMLS CUI-1)
C0457083 (UMLS CUI-2)
Date of First Study Treatment
Item
Date of First Study Treatment
date
C3173309 (UMLS CUI [1])
Item
Please indicate if the first dose was a morning (AM) or evening (PM) dose
integer
C3174092 (UMLS CUI [1,1])
C0205435 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Please indicate if the first dose was a morning (AM) or evening (PM) dose
Code List
Please indicate if the first dose was a morning (AM) or evening (PM) dose
CL Item
AM (1)
CL Item
PM (2)
Date of Last Study Treatment
Item
Date of Last Study Treatment (If date of last study treatment is not certain, enter the last known date of treatment)
date
C1531784 (UMLS CUI [1])
Item
Please indicate if the last dose was a morning (AM) or evening (PM) dose
integer
C0178602 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Please indicate if the last dose was a morning (AM) or evening (PM) dose
Code List
Please indicate if the last dose was a morning (AM) or evening (PM) dose
CL Item
AM (1)
CL Item
PM (2)
Has the subject missed any study product applications as specified in the protocol?
Item
Between the Date of First Study Treatment and the Date of Last Study Treatment, has the subject missed any study product applications as specified in the protocol?
boolean
C1709043 (UMLS CUI [1])
Date of Missed Treatment
Item
Date of Missed Treatment
date
C1709043 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Check if AM treatment missed
integer
C1709043 (UMLS CUI [1,1])
C4331833 (UMLS CUI [1,2])
Check if AM treatment missed
Code List
Check if AM treatment missed
CL Item
AM treatment missed (1)
Item
Check if PM treatment missed
integer
C1709043 (UMLS CUI [1,1])
C1509133 (UMLS CUI [1,2])
Check if PM treatment missed
Code List
Check if PM treatment missed
CL Item
PM treatment missed (1)
Item Group
Photographs
C0441468 (UMLS CUI-1)
Item
If consent to photographs was not given, please check box:
integer
C0021430 (UMLS CUI [1,1])
C0441468 (UMLS CUI [1,2])
If consent to photographs was not given, please check box:
Code List
If consent to photographs was not given, please check box:
CL Item
Consent to photographs was not given (1)
Item
Visit
integer
C0545082 (UMLS CUI [1])
Visit
Code List
Visit
CL Item
Baseline (1)
CL Item
Day 3 (2)
CL Item
Day 8 (3)
CL Item
Day 15 / Early Withdrawal (4)
Date of Photograph
Item
Date of Photograph
date
C0441468 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Or check if Photograph Not Done
integer
C0441468 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
Or check if Photograph Not Done
Code List
Or check if Photograph Not Done
CL Item
Photograph not done (1)
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