ID
35673
Beschrijving
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.
Link
https://clinicaltrials.gov/ct2/show/NCT00852540
Trefwoorden
Versies (3)
- 04-03-19 04-03-19 -
- 11-03-19 11-03-19 -
- 15-03-19 15-03-19 - Sarah Riepenhausen
Houder van rechten
GlaxoSmithKline
Geüploaded op
15 maart 2019
DOI
Voor een aanvraag inloggen.
Licentie
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
Beschrijving
Study conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008972
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0422727
- UMLS CUI [2]
- C1549507
Beschrijving
Withdrawl
Datatype
text
Alias
- UMLS CUI [1]
- C0422727
Beschrijving
Select "Investigator discretion" and "Withdrew consent" if none of the other primary reasons are appropriate.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C1549995
Beschrijving
Pregnancy
Datatype
boolean
Alias
- UMLS CUI [1]
- C0032961
Beschrijving
Complete this item, if you ticked "Investigator discretion" as primary reason for withdrawal.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0008961
- UMLS CUI [1,3]
- C0022423
Beschrijving
Complete this item, if you ticked "Withdrew consent" as primary reason for withdrawal.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C1707492
Beschrijving
Investigational product
Alias
- UMLS CUI-1
- C0304229
Beschrijving
Investigational product
Datatype
integer
Alias
- UMLS CUI [1]
- C0304229
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1]
- C3173309
Beschrijving
00:00-23:59
Datatype
time
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0205435
- UMLS CUI [1,3]
- C0178602
- UMLS CUI [1,4]
- C0040223
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1762893
Beschrijving
00:00-23:59
Datatype
time
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0946444
Beschrijving
For topical study drug only.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0185125
- UMLS CUI [1,2]
- C0449788
Beschrijving
For oral study drug only.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0750480
Beschrijving
Status of treatment blind
Alias
- UMLS CUI-1
- C0749659
- UMLS CUI-2
- C2347038
Beschrijving
If yes, complete Non-Serious Adverse Events, Serious Adverse Event and/or Investigational Product forms as appropriate
Datatype
text
Alias
- UMLS CUI [1]
- C3897431
Beschrijving
day month year. Complete if treatment blind was broken during the study.
Datatype
date
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0011008
Beschrijving
Complete if treatment blind was broken during the study.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0566251
Beschrijving
Other reason blind broken
Datatype
text
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0566251
Beschrijving
Pregnancy information
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C1533716
Beschrijving
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])