ID
35673
Descripción
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
Palabras clave
Versiones (3)
- 4/3/19 4/3/19 -
- 11/3/19 11/3/19 -
- 15/3/19 15/3/19 - Sarah Riepenhausen
Titular de derechos de autor
GlaxoSmithKline
Subido en
15 de marzo de 2019
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
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
Descripción
Study conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008972
Descripción
day month year
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0422727
- UMLS CUI [2]
- C1549507
Descripción
Withdrawl
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0422727
Descripción
Select "Investigator discretion" and "Withdrew consent" if none of the other primary reasons are appropriate.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C1549995
Descripción
Pregnancy
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0032961
Descripción
Complete this item, if you ticked "Investigator discretion" as primary reason for withdrawal.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0008961
- UMLS CUI [1,3]
- C0022423
Descripción
Complete this item, if you ticked "Withdrew consent" as primary reason for withdrawal.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C1707492
Descripción
Investigational product
Alias
- UMLS CUI-1
- C0304229
Descripción
Investigational product
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0304229
Descripción
day month year
Tipo de datos
date
Alias
- UMLS CUI [1]
- C3173309
Descripción
00:00-23:59
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0205435
- UMLS CUI [1,3]
- C0178602
- UMLS CUI [1,4]
- C0040223
Descripción
day month year
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1762893
Descripción
00:00-23:59
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0946444
Descripción
For topical study drug only.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0185125
- UMLS CUI [1,2]
- C0449788
Descripción
For oral study drug only.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0750480
Descripción
Status of treatment blind
Alias
- UMLS CUI-1
- C0749659
- UMLS CUI-2
- C2347038
Descripción
If yes, complete Non-Serious Adverse Events, Serious Adverse Event and/or Investigational Product forms as appropriate
Tipo de datos
text
Alias
- UMLS CUI [1]
- C3897431
Descripción
day month year. Complete if treatment blind was broken during the study.
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0011008
Descripción
Complete if treatment blind was broken during the study.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0566251
Descripción
Other reason blind broken
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0566251
Descripción
Pregnancy information
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C1533716
Descripción
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])