ID
34829
Beschrijving
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
Trefwoorden
Versies (1)
- 30-01-19 30-01-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
30 januari 2019
DOI
Voor een aanvraag inloggen.
Licentie
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
Beschrijving
Concomitant Medications
Alias
- UMLS CUI-1
- C2347852
Beschrijving
no Concomitant Medications including MOISTURIZER to report
Datatype
integer
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2347804
- UMLS CUI [2,1]
- C3848663
- UMLS CUI [2,2]
- C2347804
Beschrijving
Medication
Datatype
text
Alias
- UMLS CUI [1]
- C0013227
Beschrijving
Administration Route
Datatype
text
Alias
- UMLS CUI [1]
- C0013153
Beschrijving
Medication Start Date
Datatype
date
Alias
- UMLS CUI [1]
- C2826734
Beschrijving
Medication Stop Date
Datatype
date
Alias
- UMLS CUI [1]
- C2826744
Beschrijving
Check if medication continuing at end of study
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0549178
- UMLS CUI [2,1]
- C0008972
- UMLS CUI [2,2]
- C0444930
Beschrijving
Indication Medication (Reason for use)
Datatype
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C3146298
Beschrijving
Concomitant Procedures
Alias
- UMLS CUI-1
- C1707479
Beschrijving
No Concomitant Procedures to report
Datatype
text
Alias
- UMLS CUI [1,1]
- C1707479
- UMLS CUI [1,2]
- C2347804
Beschrijving
Procedure
Datatype
text
Alias
- UMLS CUI [1]
- C0199171
Beschrijving
Start Date of Procedure
Datatype
date
Alias
- UMLS CUI [1,1]
- C0199171
- UMLS CUI [1,2]
- C0808070
Beschrijving
Stop Date of Procedure
Datatype
date
Alias
- UMLS CUI [1,1]
- C0199171
- UMLS CUI [1,2]
- C0806020
Beschrijving
Check if Procedure continuing at End of Study
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1553904
- UMLS CUI [1,2]
- C0008972
- UMLS CUI [1,3]
- C0444930
Beschrijving
Indication (Reason for procedure)
Datatype
text
Alias
- UMLS CUI [1,1]
- C0199171
- UMLS CUI [1,2]
- C3146298
Beschrijving
Adverse Events
Alias
- UMLS CUI-1
- C0877248
Beschrijving
No Adverse Events to report
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C2347804
Beschrijving
Adverse Event
Datatype
text
Alias
- UMLS CUI [1]
- C0877248
Beschrijving
Start Date of Adverse Event
Datatype
date
Alias
- UMLS CUI [1]
- C2697888
Beschrijving
End Date of Adverse Event
Datatype
date
Alias
- UMLS CUI [1]
- C2697886
Beschrijving
Check if Adverse Event continuing at end of study
Datatype
integer
Alias
- UMLS CUI [1,1]
- C2826663
- UMLS CUI [1,2]
- C0008972
- UMLS CUI [1,3]
- C0444930
Beschrijving
Adverse Event Severity
Datatype
integer
Alias
- UMLS CUI [1]
- C1710066
Beschrijving
AE caused by the investigational product?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0085978
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C0304229
Beschrijving
Action taken with Study treatment
Datatype
integer
Alias
- UMLS CUI [1]
- C2826626
Beschrijving
Concomitant or Additional Treatment Given
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1706712
- UMLS CUI [1,2]
- C1707479
Beschrijving
Was the Adverse Event serious?
Datatype
boolean
Alias
- UMLS CUI [1]
- C1519255
Beschrijving
General Comments
Alias
- UMLS CUI-1
- C0947611
Beschrijving
Subject's Post-Study Questionnaire
Alias
- UMLS CUI-1
- C0681850
- UMLS CUI-2
- C0034394
- UMLS CUI-3
- C0008972
- UMLS CUI-4
- C0687676
Beschrijving
1 - Skin Medicines used in past
Alias
- UMLS CUI-1
- C1123023
- UMLS CUI-2
- C0013227
- UMLS CUI-3
- C0205156
Beschrijving
Gel Preference
Datatype
text
Alias
- UMLS CUI [1,1]
- C0017243
- UMLS CUI [1,2]
- C0558295
Beschrijving
Lotion Preference
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0544341
- UMLS CUI [1,2]
- C0558295
Beschrijving
undefined item
Datatype
text
Alias
- UMLS CUI [1,1]
- C0544341
- UMLS CUI [1,2]
- C0558295
Beschrijving
Cream Preference
Datatype
text
Alias
- UMLS CUI [1,1]
- C1378128
- UMLS CUI [1,2]
- C0558295
Beschrijving
Ointment Preference
Datatype
text
Alias
- UMLS CUI [1,1]
- C0028912
- UMLS CUI [1,2]
- C0558295
Beschrijving
Ointment Preference
Datatype
text
Alias
- UMLS CUI [1,1]
- C0028912
- UMLS CUI [1,2]
- C0558295
Beschrijving
Spray Preference
Datatype
text
Alias
- UMLS CUI [1,1]
- C4521772
- UMLS CUI [1,2]
- C0558295
Beschrijving
2 - Rate Qualities of Foam
Alias
- UMLS CUI-1
- C0991510
- UMLS CUI-2
- C0332306
Beschrijving
Foam easy to use
Datatype
text
Alias
- UMLS CUI [1,1]
- C0991510
- UMLS CUI [1,2]
- C0457083
- UMLS CUI [1,3]
- C0332219
Beschrijving
Able to continue daily activities
Datatype
text
Alias
- UMLS CUI [1,1]
- C0001288
- UMLS CUI [1,2]
- C0085732
Beschrijving
Leaves my skin feeling soft
Datatype
text
Alias
- UMLS CUI [1,1]
- C1123023
- UMLS CUI [1,2]
- C0205358
Beschrijving
Able to apply foam to large body surface areas
Datatype
text
Alias
- UMLS CUI [1,1]
- C0185125
- UMLS CUI [1,2]
- C0085732
- UMLS CUI [1,3]
- C0991510
Beschrijving
Disappears into my skin quickly
Datatype
text
Alias
- UMLS CUI [1,1]
- C1701930
- UMLS CUI [1,2]
- C1123023
Beschrijving
3 - Rate the Foam
Alias
- UMLS CUI-1
- C0991510
- UMLS CUI-2
- C0220825
Beschrijving
Moisturizing
Datatype
text
Alias
- UMLS CUI [1]
- C1646056
Beschrijving
Lack of residue
Datatype
text
Alias
- UMLS CUI [1,1]
- C0332268
- UMLS CUI [1,2]
- C1709915
Beschrijving
Does not feel greasy
Datatype
text
Alias
- UMLS CUI [1]
- C0234925
Beschrijving
Absorbs quickly
Datatype
text
Alias
- UMLS CUI [1,1]
- C0000854
- UMLS CUI [1,2]
- C0456962
Beschrijving
Easy to apply
Datatype
text
Alias
- UMLS CUI [1,1]
- C0185125
- UMLS CUI [1,2]
- C0332219
Beschrijving
Fragrance free
Datatype
text
Alias
- UMLS CUI [1,1]
- C0031000
- UMLS CUI [1,2]
- C0332296
Beschrijving
Spreadability
Datatype
text
Alias
- UMLS CUI [1]
- C3846158
Beschrijving
Lack of stickiness
Datatype
text
Alias
- UMLS CUI [1,1]
- C0392162
- UMLS CUI [1,2]
- C0022902
Beschrijving
4 - Compare Foam to Other Types of Skin Medicines
Alias
- UMLS CUI-1
- C0991510
- UMLS CUI-2
- C1707455
- UMLS CUI-3
- C1123023
- UMLS CUI-4
- C0013227
- UMLS CUI-5
- C0205394
Beschrijving
Gel - foam comparison
Datatype
text
Alias
- UMLS CUI [1,1]
- C0017243
- UMLS CUI [1,2]
- C0991510
- UMLS CUI [1,3]
- C1707455
Beschrijving
Cream - foam comparison
Datatype
text
Alias
- UMLS CUI [1,1]
- C1378128
- UMLS CUI [1,2]
- C0991510
- UMLS CUI [1,3]
- C1707455
Beschrijving
Ointment - foam comparison
Datatype
text
Alias
- UMLS CUI [1,1]
- C0028912
- UMLS CUI [1,2]
- C0991510
- UMLS CUI [1,3]
- C1707455
Beschrijving
Lotion - foam comparison
Datatype
text
Alias
- UMLS CUI [1,1]
- C0544341
- UMLS CUI [1,2]
- C0991510
- UMLS CUI [1,3]
- C1707455
Beschrijving
Spray - foam comparison
Datatype
text
Alias
- UMLS CUI [1,1]
- C4521772
- UMLS CUI [1,2]
- C0991510
- UMLS CUI [1,3]
- C1707455
Beschrijving
5 - Likely to be compliant using various types of Medicines
Alias
- UMLS CUI-1
- C1321605
- UMLS CUI-2
- C0457083
- UMLS CUI-3
- C0013227
- UMLS CUI-4
- C0443302
Beschrijving
Likely w/ a foam
Datatype
text
Alias
- UMLS CUI [1,1]
- C0750501
- UMLS CUI [1,2]
- C0991510
Beschrijving
Likely w/ a cream
Datatype
text
Alias
- UMLS CUI [1,1]
- C0750501
- UMLS CUI [1,2]
- C1378128
Beschrijving
Likely w/ an ointment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0750501
- UMLS CUI [1,2]
- C0028912
Beschrijving
Likely w/ a gel
Datatype
text
Alias
- UMLS CUI [1,1]
- C0750501
- UMLS CUI [1,2]
- C0017243
Beschrijving
Likely w/ a lotion
Datatype
text
Alias
- UMLS CUI [1,1]
- C0750501
- UMLS CUI [1,2]
- C0544341
Beschrijving
Likely w/ a spray
Datatype
text
Alias
- UMLS CUI [1,1]
- C0750501
- UMLS CUI [1,2]
- C4521772
Beschrijving
6 - What do you like or not like about the Foam?
Alias
- UMLS CUI-1
- C0991510
- UMLS CUI-2
- C0870814
Similar models
Unscheduled Visit; Concomitant Medications; Concomitant Procedures; Adverse Events; General Comments; Subject's Post-Study Questionnaire
C3854240 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C3854240 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,2])
C3848663 (UMLS CUI [2,1])
C2347804 (UMLS CUI [2,2])
C0549178 (UMLS CUI [1,2])
C0008972 (UMLS CUI [2,1])
C0444930 (UMLS CUI [2,2])
C3146298 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0008972 (UMLS CUI [1,2])
C0444930 (UMLS CUI [1,3])
C3146298 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,2])
C0008972 (UMLS CUI [1,2])
C0444930 (UMLS CUI [1,3])
C0877248 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C1707479 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,2])
C0034394 (UMLS CUI-2)
C0008972 (UMLS CUI-3)
C0687676 (UMLS CUI-4)
C0034394 (UMLS CUI [1,2])
C0013227 (UMLS CUI-2)
C0205156 (UMLS CUI-3)
C0558295 (UMLS CUI [1,2])
C0558295 (UMLS CUI [1,2])
C0558295 (UMLS CUI [1,2])
C0332306 (UMLS CUI-2)
C0457083 (UMLS CUI [1,2])
C0332219 (UMLS CUI [1,3])
C0085732 (UMLS CUI [1,2])
C0205358 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,2])
C0991510 (UMLS CUI [1,3])
C1123023 (UMLS CUI [1,2])
C1707455 (UMLS CUI-2)
C1123023 (UMLS CUI-3)
C0013227 (UMLS CUI-4)
C0205394 (UMLS CUI-5)
C0991510 (UMLS CUI [1,2])
C1707455 (UMLS CUI [1,3])
C0991510 (UMLS CUI [1,2])
C1707455 (UMLS CUI [1,3])
C0991510 (UMLS CUI [1,2])
C1707455 (UMLS CUI [1,3])
C0991510 (UMLS CUI [1,2])
C1707455 (UMLS CUI [1,3])
C0991510 (UMLS CUI [1,2])
C1707455 (UMLS CUI [1,3])
C0457083 (UMLS CUI-2)
C0013227 (UMLS CUI-3)
C0443302 (UMLS CUI-4)
C0028912 (UMLS CUI [1,2])
C0870814 (UMLS CUI-2)
C0870814 (UMLS CUI [1,2])