Informações:
Falhas:
ID
34829
Descrição
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
Palavras-chave
Versões (1)
- 30/01/2019 30/01/2019 -
Titular dos direitos
GlaxoSmithKline
Transferido a
30 de janeiro de 2019
DOI
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Licença
Creative Commons BY-NC 3.0
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Ethanol-Free Clobetasol Propionate Foam vs Vehicle Foam in Chronic Hand Dermatitis NCT01323673
Unscheduled Visit; Concomitant Medications; Concomitant Procedures; Adverse Events; General Comments; Subject's Post-Study Questionnaire
Similar models
Unscheduled Visit; Concomitant Medications; Concomitant Procedures; Adverse Events; General Comments; Subject's Post-Study Questionnaire
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Unscheduled Visit Date
Item
Unscheduled Visit Date
date
C0545082 (UMLS CUI [1,1])
C3854240 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C3854240 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Please select which Unscheduled forms to add to this visit:
integer
C0545082 (UMLS CUI [1,1])
C3854240 (UMLS CUI [1,2])
C3854240 (UMLS CUI [1,2])
Code List
Please select which Unscheduled forms to add to this visit:
CL Item
Add Efficacy Assessment form (1)
CL Item
Add Urine Pregnancy form (2)
Item
If there are no Concomitant Medications including MOISTURIZER to report during the course of the study, place a check in the box:
integer
C2347852 (UMLS CUI [1,1])
C2347804 (UMLS CUI [1,2])
C3848663 (UMLS CUI [2,1])
C2347804 (UMLS CUI [2,2])
C2347804 (UMLS CUI [1,2])
C3848663 (UMLS CUI [2,1])
C2347804 (UMLS CUI [2,2])
Code List
If there are no Concomitant Medications including MOISTURIZER to report during the course of the study, place a check in the box:
CL Item
No Concomitant Medications including MOISTURIZER to report (1)
Medication
Item
Medication
text
C0013227 (UMLS CUI [1])
CL Item
Oral (PO)
CL Item
Topical (TOP)
CL Item
Inhalation/ Respiratory (IHN)
CL Item
Intra- arterial (IA)
CL Item
Intra- articular (IAR)
CL Item
Intradermal (ID)
CL Item
Intramuscular (IM)
CL Item
Intraocular (IO)
CL Item
Intrathecal (IT)
CL Item
Intrauterine (IU)
CL Item
Intravenous (IV)
CL Item
Nasal (NAS)
CL Item
Rectal (PR)
CL Item
Subcutaneous (SC)
CL Item
Sublingual (SL)
CL Item
Transdermal (TD)
CL Item
Vaginal (VAG)
CL Item
Other (OTH)
Medication Start Date
Item
Medication Start Date
date
C2826734 (UMLS CUI [1])
Medication Stop Date
Item
Medication Stop Date
date
C2826744 (UMLS CUI [1])
Item
Check if medication continuing at end of study
integer
C0013227 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0008972 (UMLS CUI [2,1])
C0444930 (UMLS CUI [2,2])
C0549178 (UMLS CUI [1,2])
C0008972 (UMLS CUI [2,1])
C0444930 (UMLS CUI [2,2])
Code List
Check if medication continuing at end of study
CL Item
Medication continuing at end of study (1)
Indication Medication (Reason for use)
Item
Indication for Medication (Reason for use)
text
C0013227 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,2])
Item
If there are no Concomitant Procedures to report during the course of the study, place a check in the box:
text
C1707479 (UMLS CUI [1,1])
C2347804 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,2])
Code List
If there are no Concomitant Procedures to report during the course of the study, place a check in the box:
CL Item
No Concomitant Procedures to report (1)
Procedure
Item
Procedure
text
C0199171 (UMLS CUI [1])
Start Date of Procedure
Item
Start Date of Procedure
date
C0199171 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
Stop Date of Procedure
Item
Stop Date of Procedure
date
C0199171 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
Item
Check if Procedure continuing at End of Study
integer
C1553904 (UMLS CUI [1,1])
C0008972 (UMLS CUI [1,2])
C0444930 (UMLS CUI [1,3])
C0008972 (UMLS CUI [1,2])
C0444930 (UMLS CUI [1,3])
Code List
Check if Procedure continuing at End of Study
CL Item
Procedure continuing at End of Study (1)
Indication (Reason for procedure)
Item
Indication (Reason for procedure)
text
C0199171 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,2])
Item
If there are no Adverse Events to report during the course of the study, place a check in the box:
integer
C0877248 (UMLS CUI [1,1])
C2347804 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,2])
Code List
If there are no Adverse Events to report during the course of the study, place a check in the box:
CL Item
No Adverse Events to report (1)
Adverse Event
Item
Adverse Event
text
C0877248 (UMLS CUI [1])
Start Date of Adverse Event
Item
Start Date of Adverse Event
date
C2697888 (UMLS CUI [1])
End Date of Adverse Event
Item
End Date of Adverse Event
date
C2697886 (UMLS CUI [1])
Item
Check if Adverse Event continuing at end of study
integer
C2826663 (UMLS CUI [1,1])
C0008972 (UMLS CUI [1,2])
C0444930 (UMLS CUI [1,3])
C0008972 (UMLS CUI [1,2])
C0444930 (UMLS CUI [1,3])
Code List
Check if Adverse Event continuing at end of study
CL Item
Adverse Event continuing at end of study (1)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
AE caused by the investigational product?
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C0085978 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0877248 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Item
Action taken with Study treatment
integer
C2826626 (UMLS CUI [1])
CL Item
Dose not changed (1)
CL Item
Dose increased (2)
CL Item
Dose decreased (3)
CL Item
Drug interrupted (4)
CL Item
Drug withdrawn (5)
Concomitant or Additional Treatment Given
Item
Concomitant or Additional Treatment Given
boolean
C1706712 (UMLS CUI [1,1])
C1707479 (UMLS CUI [1,2])
C1707479 (UMLS CUI [1,2])
Was the Adverse Event serious?
Item
Was the Adverse Event serious?
boolean
C1519255 (UMLS CUI [1])
Item
If there are no comments to report during the course of the study, place a check in the box:
integer
C0947611 (UMLS CUI [1,1])
C2347804 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,2])
Code List
If there are no comments to report during the course of the study, place a check in the box:
CL Item
No comments to report (1)
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Item Group
Subject's Post-Study Questionnaire
C0681850 (UMLS CUI-1)
C0034394 (UMLS CUI-2)
C0008972 (UMLS CUI-3)
C0687676 (UMLS CUI-4)
C0034394 (UMLS CUI-2)
C0008972 (UMLS CUI-3)
C0687676 (UMLS CUI-4)
Item
If the subject did not complete the questionnaire for this visit, please check the box:
integer
C0205197 (UMLS CUI [1,1])
C0034394 (UMLS CUI [1,2])
C0034394 (UMLS CUI [1,2])
Code List
If the subject did not complete the questionnaire for this visit, please check the box:
CL Item
Subject did not complete the questionnaire for this visit (1)
Item Group
1 - Skin Medicines used in past
C1123023 (UMLS CUI-1)
C0013227 (UMLS CUI-2)
C0205156 (UMLS CUI-3)
C0013227 (UMLS CUI-2)
C0205156 (UMLS CUI-3)
CL Item
Liked the best (1)
CL Item
Liked second best (2)
CL Item
Liked third best (3)
CL Item
Liked fourth best (4)
CL Item
Liked the least (5)
CL Item
Does not apply to me (NA)
Lotion Preference
Item
Lotion Preference
integer
C0544341 (UMLS CUI [1,1])
C0558295 (UMLS CUI [1,2])
C0558295 (UMLS CUI [1,2])
CL Item
Liked the best (1)
CL Item
Liked second best (2)
CL Item
Liked third best (3)
CL Item
Liked fourth best (4)
CL Item
Liked the least (5)
CL Item
Does not apply to me (NA)
CL Item
Liked the best (1)
CL Item
Liked second best (2)
CL Item
Liked third best (3)
CL Item
Liked fourth best (4)
CL Item
Liked the least (5)
CL Item
Does not apply to me (NA)
Item
Ointment Preference
text
C0028912 (UMLS CUI [1,1])
C0558295 (UMLS CUI [1,2])
C0558295 (UMLS CUI [1,2])
CL Item
Liked the best (1)
CL Item
Liked second best (2)
CL Item
Liked third best (3)
CL Item
Liked fourth best (4)
CL Item
Liked the least (5)
CL Item
Does not apply to me (NA)
Item
Ointment Preference
text
C0028912 (UMLS CUI [1,1])
C0558295 (UMLS CUI [1,2])
C0558295 (UMLS CUI [1,2])
CL Item
Liked the best (1)
CL Item
Liked second best (2)
CL Item
Liked third best (3)
CL Item
Liked fourth best (4)
CL Item
Liked the least (5)
CL Item
Does not apply to me (NA)
CL Item
Liked the best (1)
CL Item
Liked second best (2)
CL Item
Liked third best (3)
CL Item
Liked fourth best (4)
CL Item
Liked the least (5)
CL Item
Does not apply to me (NA)
Item Group
2 - Rate Qualities of Foam
C0991510 (UMLS CUI-1)
C0332306 (UMLS CUI-2)
C0332306 (UMLS CUI-2)
Item
Foam easy to use
text
C0991510 (UMLS CUI [1,1])
C0457083 (UMLS CUI [1,2])
C0332219 (UMLS CUI [1,3])
C0457083 (UMLS CUI [1,2])
C0332219 (UMLS CUI [1,3])
CL Item
Much worse (1)
CL Item
Worse (2)
CL Item
About the same (3)
CL Item
Better (4)
CL Item
Much better (5)
CL Item
Does not apply to me (N/A)
Item
Able to continue daily activities
text
C0001288 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,2])
CL Item
Much worse (1)
CL Item
Much worse (1)
CL Item
Worse (2)
CL Item
About the same (3)
CL Item
Better (4)
CL Item
Much better (5)
CL Item
Does not apply to me (N/A)
Item
Leaves my skin feeling soft
text
C1123023 (UMLS CUI [1,1])
C0205358 (UMLS CUI [1,2])
C0205358 (UMLS CUI [1,2])
CL Item
Much worse (1)
CL Item
Worse (2)
CL Item
About the same (3)
CL Item
Better (4)
CL Item
Much better (5)
CL Item
Does not apply to me (N/A)
Item
Able to apply foam to large body surface areas
text
C0185125 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
C0991510 (UMLS CUI [1,3])
C0085732 (UMLS CUI [1,2])
C0991510 (UMLS CUI [1,3])
Code List
Able to apply foam to large body surface areas
CL Item
Much worse (1)
CL Item
Worse (2)
CL Item
About the same (3)
CL Item
Better (4)
CL Item
Much better (5)
CL Item
Does not apply to me (N/A)
Item
Disappears into my skin quickly
text
C1701930 (UMLS CUI [1,1])
C1123023 (UMLS CUI [1,2])
C1123023 (UMLS CUI [1,2])
CL Item
Much worse (1)
CL Item
Worse (2)
CL Item
About the same (3)
CL Item
Better (4)
CL Item
Much better (5)
CL Item
Does not apply to me (N/A)
CL Item
Very poor (1)
CL Item
Poor (2)
CL Item
Fair (3)
CL Item
Good (4)
CL Item
Excellent (5)
CL Item
Does not apply to me (N/A)
CL Item
Very poor (1)
CL Item
Poor (2)
CL Item
Fair (3)
CL Item
Good (4)
CL Item
Excellent (5)
CL Item
Does not apply to me (N/A)
CL Item
Very poor (1)
CL Item
Poor (2)
CL Item
Fair (3)
CL Item
Good (4)
CL Item
Excellent (5)
CL Item
Does not apply to me (N/A)
CL Item
Very poor (1)
CL Item
Poor (2)
CL Item
Fair (3)
CL Item
Good (4)
CL Item
Excellent (5)
CL Item
Does not apply to me (N/A)
CL Item
Very poor (1)
CL Item
Poor (2)
CL Item
Fair (3)
CL Item
Good (4)
CL Item
Excellent (5)
CL Item
Does not apply to me (N/A)
CL Item
Very poor (1)
CL Item
Poor (2)
CL Item
Fair (3)
CL Item
Good (4)
CL Item
Excellent (5)
CL Item
Does not apply to me (N/A)
CL Item
Very poor (1)
CL Item
Poor (2)
CL Item
Fair (3)
CL Item
Good (4)
CL Item
Excellent (5)
CL Item
Does not apply to me (N/A)
CL Item
Very poor (1)
CL Item
Poor (2)
CL Item
Fair (3)
CL Item
Good (4)
CL Item
Excellent (5)
CL Item
Does not apply to me (N/A)
Item Group
4 - Compare Foam to Other Types of Skin Medicines
C0991510 (UMLS CUI-1)
C1707455 (UMLS CUI-2)
C1123023 (UMLS CUI-3)
C0013227 (UMLS CUI-4)
C0205394 (UMLS CUI-5)
C1707455 (UMLS CUI-2)
C1123023 (UMLS CUI-3)
C0013227 (UMLS CUI-4)
C0205394 (UMLS CUI-5)
Item
Gel - foam comparison
text
C0017243 (UMLS CUI [1,1])
C0991510 (UMLS CUI [1,2])
C1707455 (UMLS CUI [1,3])
C0991510 (UMLS CUI [1,2])
C1707455 (UMLS CUI [1,3])
CL Item
Much worse (1)
CL Item
Worse (2)
CL Item
About the same (3)
CL Item
Better (4)
CL Item
Much better (5)
CL Item
Does not apply to me (N/A)
Item
Cream - foam comparison
text
C1378128 (UMLS CUI [1,1])
C0991510 (UMLS CUI [1,2])
C1707455 (UMLS CUI [1,3])
C0991510 (UMLS CUI [1,2])
C1707455 (UMLS CUI [1,3])
CL Item
Much worse (1)
CL Item
Worse (2)
CL Item
About the same (3)
CL Item
Better (4)
CL Item
Much better (5)
CL Item
Does not apply to me (N/A)
Item
Ointment - foam comparison
text
C0028912 (UMLS CUI [1,1])
C0991510 (UMLS CUI [1,2])
C1707455 (UMLS CUI [1,3])
C0991510 (UMLS CUI [1,2])
C1707455 (UMLS CUI [1,3])
CL Item
Much worse (1)
CL Item
Worse (2)
CL Item
About the same (3)
CL Item
Better (4)
CL Item
Much better (5)
CL Item
Does not apply to me (N/A)
Item
Lotion - foam comparison
text
C0544341 (UMLS CUI [1,1])
C0991510 (UMLS CUI [1,2])
C1707455 (UMLS CUI [1,3])
C0991510 (UMLS CUI [1,2])
C1707455 (UMLS CUI [1,3])
CL Item
Much worse (1)
CL Item
Worse (2)
CL Item
About the same (3)
CL Item
Better (4)
CL Item
Much better (5)
CL Item
Does not apply to me (N/A)
Item
Spray - foam comparison
text
C4521772 (UMLS CUI [1,1])
C0991510 (UMLS CUI [1,2])
C1707455 (UMLS CUI [1,3])
C0991510 (UMLS CUI [1,2])
C1707455 (UMLS CUI [1,3])
CL Item
Much worse (1)
CL Item
Worse (2)
CL Item
About the same (3)
CL Item
Better (4)
CL Item
Much better (5)
CL Item
Does not apply to me (N/A)
Item Group
5 - Likely to be compliant using various types of Medicines
C1321605 (UMLS CUI-1)
C0457083 (UMLS CUI-2)
C0013227 (UMLS CUI-3)
C0443302 (UMLS CUI-4)
C0457083 (UMLS CUI-2)
C0013227 (UMLS CUI-3)
C0443302 (UMLS CUI-4)
CL Item
Hardly ever (<=24%) (1)
CL Item
Some of the time (25-49%) (2)
CL Item
Half of the time (50-74%) (3)
CL Item
Most of the time (75-99%) (4)
CL Item
All of the time (100%) (5)
CL Item
Does not apply to me (NA)
CL Item
Hardly ever (<=24%) (1)
CL Item
Some of the time (25-49%) (2)
CL Item
Half of the time (50-74%) (3)
CL Item
Most of the time (75-99%) (4)
CL Item
All of the time (100%) (5)
CL Item
Does not apply to me (NA)
Item
Likely w/ an ointment
text
C0750501 (UMLS CUI [1,1])
C0028912 (UMLS CUI [1,2])
C0028912 (UMLS CUI [1,2])
CL Item
Hardly ever (<=24%) (1)
CL Item
Some of the time (25-49%) (2)
CL Item
Half of the time (50-74%) (3)
CL Item
Most of the time (75-99%) (4)
CL Item
All of the time (100%) (5)
CL Item
Does not apply to me (NA)
CL Item
Hardly ever (<=24%) (1)
CL Item
Some of the time (25-49%) (2)
CL Item
Half of the time (50-74%) (3)
CL Item
Most of the time (75-99%) (4)
CL Item
All of the time (100%) (5)
CL Item
Does not apply to me (NA)
CL Item
Hardly ever (<=24%) (1)
CL Item
Some of the time (25-49%) (2)
CL Item
Half of the time (50-74%) (3)
CL Item
Most of the time (75-99%) (4)
CL Item
All of the time (100%) (5)
CL Item
Does not apply to me (NA)
CL Item
Hardly ever (<=24%) (1)
CL Item
Some of the time (25-49%) (2)
CL Item
Half of the time (50-74%) (3)
CL Item
Most of the time (75-99%) (4)
CL Item
All of the time (100%) (5)
CL Item
Does not apply to me (NA)
Item Group
6 - What do you like or not like about the Foam?
C0991510 (UMLS CUI-1)
C0870814 (UMLS CUI-2)
C0870814 (UMLS CUI-2)
6 - What do you like or not like about the Foam?
Item
6 - What do you like or not like about the Foam?
text
C0991510 (UMLS CUI [1,1])
C0870814 (UMLS CUI [1,2])
C0870814 (UMLS CUI [1,2])