ID

35418

Description

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 concomitant medication and Subject product preference form. The concomitant medication has to be filled in if subject use concomitant medications during study.

Link

https://clinicaltrials.gov/ct2/show/NCT00852540

Keywords

Versions (3)
  1. 3/4/19 3/4/19 -
  2. 3/4/19 3/4/19 -
  3. 3/11/19 3/11/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

March 4, 2019

DOI

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License

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

English

Concomitant medication, Subject product preference

1 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Prior medications
Description

Prior medications

Alias
UMLS CUI-1
C2347852
Drug Name
Description

(Trade Name preferred)

Data type

text

Alias
UMLS CUI [1]
C0013227
Total Daily Dose
Description

Total Daily Dose

Data type

text

Alias
UMLS CUI [1,1]
C2348070
UMLS CUI [1,2]
C0013227
Units of medication
Description

Units

Data type

integer

Alias
UMLS CUI [1]
C1519795
Route of medication
Description

Route

Data type

integer

Alias
UMLS CUI [1]
C0013153
Reason for Medication
Description

Reason for Medication

Data type

text

Alias
UMLS CUI [1]
C2826696
Start Date of medication
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
Taken prior to study?
Description

Taken prior to study

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C2347804
Ongoing?
Description

Ongoing of medication

Data type

text

Alias
UMLS CUI [1]
C2826666
If no ongoing of medication, specify End date
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Subject medication preference
Description

Subject medication preference

Alias
UMLS CUI-1
C3854006
UMLS CUI-2
C0030705
UMLS CUI-3
C0558295
Subject product preference
Description

Subject product preference

Data type

integer

Alias
UMLS CUI [1,1]
C3854006
UMLS CUI [1,2]
C0030705
UMLS CUI [1,3]
C0558295
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Similar models

Concomitant medication, Subject product preference

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item Group
Prior medications
C2347852 (UMLS CUI-1)
Drug Name
Item
Drug Name
text
C0013227 (UMLS CUI [1])
Total Daily Dose
Item
Total Daily Dose
text
C2348070 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Item
Units of medication
integer
C1519795 (UMLS CUI [1])
Units
Code List
Units of medication
CL Item
Actuation (1)
CL Item
Ampoule (2)
CL Item
Application (3)
CL Item
Area under curve (4)
CL Item
Bottle (5)
CL Item
Capsule (6)
CL Item
Cubic centimeter (7)
CL Item
Cup (8)
CL Item
Drops (9)
CL Item
Finger tip unit (10)
CL Item
Gramma per kilogram per minute (11)
CL Item
Gram (12)
CL Item
Grams per kilogram (13)
CL Item
Grams per litre (14)
CL Item
Grams per metre squared (15)
CL Item
Grams per millilitre (16)
CL Item
Inhalation (17)
CL Item
100 International units/ml (18)
CL Item
International units per kilogram (19)
CL Item
International units per kilogram per hour (20)
CL Item
International units per millilitre (21)
CL Item
Litre (22)
CL Item
Litres per minute (23)
CL Item
Lozenge (24)
CL Item
Mega becquerels (MBq) (25)
CL Item
Megaunits (million units) (26)
CL Item
Microgram (MCG) (27)
CL Item
Microgram (UG) (28)
CL Item
Micrograms per gram (29)
CL Item
Micrograms per hour (30)
CL Item
Microgram per kilogram (31)
CL Item
Microgram per kilogram per minute (32)
CL Item
Micrograms per millilitre (33)
CL Item
Micrograms per minute (34)
CL Item
Microlitre (35)
CL Item
Micromoles (36)
CL Item
Micromoles per 24 hours (37)
CL Item
Millicurie (38)
CL Item
Milliequivalent (39)
CL Item
Milliequivalents per 24 hours (40)
CL Item
Milligram (41)
CL Item
Milligram per day (42)
CL Item
Milligram per hour (43)
CL Item
Milligram per kilogram (44)
CL Item
Milligram per kilogram per hour (45)
CL Item
Milligram per kilogram per minute (46)
CL Item
Milligrams per metre squared (47)
CL Item
Milligrams per millilitre (48)
CL Item
Milligrams percent (49)
CL Item
Millilitre (50)
CL Item
Millilitres per hour (51)
CL Item
Millilitres per minute (52)
CL Item
Millimole (53)
CL Item
Millimoles per kilogram (54)
CL Item
Millimoles per millilitre (55)
CL Item
Million international unit (56)
CL Item
Minimum alveolar concentration (57)
CL Item
Nanogram per kilogram per minute (58)
CL Item
Nebule (59)
CL Item
Ounce (60)
CL Item
Pack (61)
CL Item
Patch (62)
CL Item
Percent (63)
CL Item
Puff (64)
CL Item
Ring (65)
CL Item
Sachet (66)
CL Item
Spray (67)
CL Item
Suppository (68)
CL Item
Tablet (69)
CL Item
Tablespoon (70)
CL Item
Teaspoon (71)
CL Item
Units (72)
CL Item
Units per gram (73)
CL Item
Units per hour (74)
CL Item
Units per kilogram per minute (75)
CL Item
Units per minute (76)
CL Item
Unknown (77)
CL Item
Vial (78)
Item
Route of medication
integer
C0013153 (UMLS CUI [1])
Route
Code List
Route of medication
CL Item
Epidural (1)
CL Item
Gastrostomy tube (2)
CL Item
Intra-arterial (3)
CL Item
Intra-articular (4)
CL Item
Intra-bursa (5)
CL Item
Intradermal (6)
CL Item
Inhalation (7)
CL Item
Intralesional (8)
CL Item
Intramuscular (9)
CL Item
Intranasal (10)
CL Item
Injection (11)
CL Item
Intraocular (12)
CL Item
Intraosteal (13)
CL Item
Intraperitoneal (14)
CL Item
Intrathecal (15)
CL Item
Intrauterine (16)
CL Item
Intravenouse (17)
CL Item
Jejunostomy feeding tube (JEJ or PEJ) (18)
CL Item
Nasogastric (19)
CL Item
Nasal (20)
CL Item
Right eye (21)
CL Item
Opthalmic (22)
CL Item
Left eye (23)
CL Item
Otic (24)
CL Item
Other (25)
CL Item
Both eyes (26)
CL Item
Oral (27)
CL Item
Rectal  (28)
CL Item
Subcutaneous (29)
CL Item
Sublingual (30)
CL Item
Transdermal (31)
CL Item
Transmucosal (32)
CL Item
Topical (33)
CL Item
Unknown (34)
CL Item
Vaginal (35)
Reason for Medication
Item
Reason for Medication
text
C2826696 (UMLS CUI [1])
Start Date of medication
Item
Start Date of medication
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item
Taken prior to study?
text
C2347852 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
Taken prior to study
Code List
Taken prior to study?
CL Item
Yes (Y)
CL Item
No (N)
Item
Ongoing?
text
C2826666 (UMLS CUI [1])
Ongoing of medication
Code List
Ongoing?
CL Item
Yes (Y)
CL Item
No (N)
End date of medication
Item
If no ongoing of medication, specify End date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item Group
Subject medication preference
C3854006 (UMLS CUI-1)
C0030705 (UMLS CUI-2)
C0558295 (UMLS CUI-3)
Item
Subject product preference
integer
C3854006 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C0558295 (UMLS CUI [1,3])
Subject product preference
Code List
Subject product preference
CL Item
Prefer oral medication (1)
CL Item
Prefer topical medication (2)
CL Item
No preference (3)
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