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