ID
35673
Beskrivning
Study ID: 110978 Clinical Study ID: 110978 Study Title: A Randomized, Double-Blind, Double Dummy, Comparative, Multicenter Study to Assess the Safety and Efficacy of Topical Retapamulin Ointment, 1%, versus Oral Linezolid in the Treatment of Secondarily-Infected Traumatic Lesions and Impetigo Due to Methicillin-Resistant Staphylococcus aureus Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00852540 https://clinicaltrials.gov/ct2/show/NCT00852540 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Retapamulin Ointment, Oral Linezolid Trade Name: N/A Study Indication: Skin Infections, Bacterial The study consists of 5 vists. The studys period extends over 19 days: Visit 1 (Day 1): Baseline (for both, topical and oral visit) Visit 2 (Day 3-4): On-Therapy (for both, topical and oral visit) Visit 3 (Day 7-9): End of Therapy for topical visit, On-Therapy for oral visit. Visit 4 (Day 12-14): Follow-up for topical visit, End of Therapy for oral visit. Visit 5 (Day 17-19): Final Follow-up for topical visit, Follow-up for oral visit. This document contains the Study conclusion, investigational product, status of treatment blind, pregnancy information and Subject product preference form. It has to be filled in for the end of study.
Länk
https://clinicaltrials.gov/ct2/show/NCT00852540
Nyckelord
Versioner (3)
- 2019-03-04 2019-03-04 -
- 2019-03-11 2019-03-11 -
- 2019-03-15 2019-03-15 - Sarah Riepenhausen
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
15 mars 2019
DOI
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Licens
Creative Commons BY-NC 3.0
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Safety and efficacy of topical Retapamulin Ointment vs. oral Linezolid in Secondarily-Infected Traumatic Lesions and Impetigo due to MRSA, NCT00852540
Study conclusion, investigational product, status of treatment blind, pregnancy information, Subject product preference
Beskrivning
Study conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008972
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0422727
- UMLS CUI [2]
- C1549507
Beskrivning
Withdrawl
Datatyp
text
Alias
- UMLS CUI [1]
- C0422727
Beskrivning
Select "Investigator discretion" and "Withdrew consent" if none of the other primary reasons are appropriate.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C1549995
Beskrivning
Pregnancy
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0032961
Beskrivning
Complete this item, if you ticked "Investigator discretion" as primary reason for withdrawal.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0008961
- UMLS CUI [1,3]
- C0022423
Beskrivning
Complete this item, if you ticked "Withdrew consent" as primary reason for withdrawal.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C1707492
Beskrivning
Investigational product
Alias
- UMLS CUI-1
- C0304229
Beskrivning
Investigational product
Datatyp
integer
Alias
- UMLS CUI [1]
- C0304229
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1]
- C3173309
Beskrivning
00:00-23:59
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0205435
- UMLS CUI [1,3]
- C0178602
- UMLS CUI [1,4]
- C0040223
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1762893
Beskrivning
00:00-23:59
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0946444
Beskrivning
For topical study drug only.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0185125
- UMLS CUI [1,2]
- C0449788
Beskrivning
For oral study drug only.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0750480
Beskrivning
Status of treatment blind
Alias
- UMLS CUI-1
- C0749659
- UMLS CUI-2
- C2347038
Beskrivning
If yes, complete Non-Serious Adverse Events, Serious Adverse Event and/or Investigational Product forms as appropriate
Datatyp
text
Alias
- UMLS CUI [1]
- C3897431
Beskrivning
day month year. Complete if treatment blind was broken during the study.
Datatyp
date
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0011008
Beskrivning
Complete if treatment blind was broken during the study.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0566251
Beskrivning
Other reason blind broken
Datatyp
text
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0566251
Beskrivning
Pregnancy information
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C1533716
Beskrivning
Subject medication preference
Alias
- UMLS CUI-1
- C3854006
- UMLS CUI-2
- C0030705
- UMLS CUI-3
- C0558295
Similar models
Study conclusion, investigational product, status of treatment blind, pregnancy information, Subject product preference
C0422727 (UMLS CUI [1,2])
C1549507 (UMLS CUI [2])
C1549995 (UMLS CUI [1,2])
C0008961 (UMLS CUI [1,2])
C0022423 (UMLS CUI [1,3])
C1707492 (UMLS CUI [1,2])
C0205435 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C1762893 (UMLS CUI [1,2])
C0946444 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,3])
C2347038 (UMLS CUI-2)
C0011008 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C0008976 (UMLS CUI [1,2])
C0030705 (UMLS CUI-2)
C0558295 (UMLS CUI-3)
C0030705 (UMLS CUI [1,2])
C0558295 (UMLS CUI [1,3])