ID

35596

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 subject diary (For subjects 5-11 years of age; <5 years of age; >=12 years of age) form. It has to be filled in for the end of study. In this Subject Diary, please record the following each day: • the date. • the time that topical medication was applied in the morning. • the time oral suspension medication was taken in the morning. • the time the topical medication was applied in the evening. • the time oral suspension medication was taken in the evening. Please use an ink pen and not a pencil. This medical research study depends on you filling in this diary EVERY DAY. Thank you for your/your child’s participation in this clinical research study. As part of this study, we are asking that, each day, you record in this "Subject Diary" information about how you/your child took the study medication. It is very important that you report in this diary the dosing information for each day that you/your child took study medication. Please bring this diary with you to each of your appointments, until the diary is collected by the study site staff. Following your/your child’s treatment, please return ALL medication tubes and bottles to the study coordinator who gave you the study medication. Thank you very much for your help.

Link

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

Keywords

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

GlaxoSmithKline

Uploaded on

March 11, 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

Eligibility Hepatitis C, Chronic NCT01356160

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
males and females 18-70 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
chronic hcv infection
Description

Hepatitis C, Chronic

Data type

boolean

Alias
UMLS CUI [1]
C0524910
subjects must have liver biopsy results (≤ 2 years prior to screening) indicating the absence of cirrhosis.
Description

Biopsy of liver | Indication Absence Liver Cirrhosis

Data type

boolean

Alias
UMLS CUI [1]
C0193388
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0023890
monoinfection with hcv genotype 1
Description

Hepatitis C Genotype

Data type

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C1533728
hcv rna > 10^4 iu/ml at screening
Description

Hepatitis C virus RNA assay

Data type

boolean

Alias
UMLS CUI [1]
C1272251
hcv treatment naïve
Description

Therapy naive Hepatitis C virus

Data type

boolean

Alias
UMLS CUI [1,1]
C0919936
UMLS CUI [1,2]
C0220847
candidate for peg/rbv therapy
Description

Patient Appropriate PEGINTERFERON/RIBAVIRIN

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C1875630
body mass index (bmi) 18-36 kg/m2, inclusive
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
agree to use two forms of highly effective contraception methods for the duration of the study and for 7 months after the last dose of study medication. females of childbearing potential must have negative pregnancy test at screening and baseline.
Description

Contraceptive methods Quantity | Childbearing Potential Pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0427780
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant female or male with pregnant female partner
Description

Pregnancy | Gender Partner Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0682323
UMLS CUI [2,3]
C0032961
exceed defined thresholds for leukopenia, neutropenia, anemia, thrombocytopenia, thyroid stimulating hormone (tsh)
Description

Leukopenia Severe | Neutropenia Severe | Anemia Severe | Thrombocytopenia Severe | Increased thyroid-stimulating hormone (TSH)

Data type

boolean

Alias
UMLS CUI [1,1]
C0023530
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0027947
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C0002871
UMLS CUI [3,2]
C0205082
UMLS CUI [4,1]
C0040034
UMLS CUI [4,2]
C0205082
UMLS CUI [5]
C1968707
diagnosis of autoimmune disease, decompensated liver disease, poorly controlled diabetes mellitus, significant psychiatric illness, severe chronic obstructive pulmonary disease (copd), hiv, hepatitis b virus (hbv), hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers), hemoglobinopathy, retinal disease, or are immunosuppressed.
Description

Autoimmune Disease | Decompensated liver disease | Poorly controlled diabetes mellitus | Mental disorders | Severe chronic obstructive pulmonary disease | HIV | Hepatitis B Virus | Liver carcinoma | Malignant Neoplasms | Exception Skin carcinoma resolved | Hemoglobinopathy | Retinal Diseases | Immunosuppressed patient

Data type

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2]
C4075847
UMLS CUI [3]
C0554876
UMLS CUI [4]
C0004936
UMLS CUI [5]
C0730607
UMLS CUI [6]
C0019682
UMLS CUI [7]
C0019169
UMLS CUI [8]
C2239176
UMLS CUI [9]
C0006826
UMLS CUI [10,1]
C1705847
UMLS CUI [10,2]
C0699893
UMLS CUI [10,3]
C1514893
UMLS CUI [11]
C0019045
UMLS CUI [12]
C0035309
UMLS CUI [13]
C0085393
subjects with current use of amphetamines, cocaine, opiates (e.g., morphine, heroin), or ongoing alcohol abuse are excluded. patients on stable methadone or buprenorphine maintenance treatment for at least 6 months prior to screening may be included into the study.
Description

Amphetamines | Cocaine | Opiates | Morphine | Heroin | Alcohol abuse | Exception Methadone Stable | Exception Buprenorphine Maintenance therapy

Data type

boolean

Alias
UMLS CUI [1]
C0002667
UMLS CUI [2]
C0009170
UMLS CUI [3]
C0376196
UMLS CUI [4]
C0026549
UMLS CUI [5]
C0011892
UMLS CUI [6]
C0085762
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0025605
UMLS CUI [7,3]
C0205360
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C0006405
UMLS CUI [8,3]
C0677908
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Similar models

Eligibility Hepatitis C, Chronic NCT01356160

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
males and females 18-70 years of age
boolean
C0001779 (UMLS CUI [1])
Hepatitis C, Chronic
Item
chronic hcv infection
boolean
C0524910 (UMLS CUI [1])
Biopsy of liver | Indication Absence Liver Cirrhosis
Item
subjects must have liver biopsy results (≤ 2 years prior to screening) indicating the absence of cirrhosis.
boolean
C0193388 (UMLS CUI [1])
C3146298 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0023890 (UMLS CUI [2,3])
Hepatitis C Genotype
Item
monoinfection with hcv genotype 1
boolean
C0019196 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
Hepatitis C virus RNA assay
Item
hcv rna > 10^4 iu/ml at screening
boolean
C1272251 (UMLS CUI [1])
Therapy naive Hepatitis C virus
Item
hcv treatment naïve
boolean
C0919936 (UMLS CUI [1,1])
C0220847 (UMLS CUI [1,2])
Patient Appropriate PEGINTERFERON/RIBAVIRIN
Item
candidate for peg/rbv therapy
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C1875630 (UMLS CUI [1,3])
Body mass index
Item
body mass index (bmi) 18-36 kg/m2, inclusive
boolean
C1305855 (UMLS CUI [1])
Contraceptive methods Quantity | Childbearing Potential Pregnancy test negative
Item
agree to use two forms of highly effective contraception methods for the duration of the study and for 7 months after the last dose of study medication. females of childbearing potential must have negative pregnancy test at screening and baseline.
boolean
C0700589 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0427780 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Gender Partner Pregnancy
Item
pregnant female or male with pregnant female partner
boolean
C0032961 (UMLS CUI [1])
C0079399 (UMLS CUI [2,1])
C0682323 (UMLS CUI [2,2])
C0032961 (UMLS CUI [2,3])
Leukopenia Severe | Neutropenia Severe | Anemia Severe | Thrombocytopenia Severe | Increased thyroid-stimulating hormone (TSH)
Item
exceed defined thresholds for leukopenia, neutropenia, anemia, thrombocytopenia, thyroid stimulating hormone (tsh)
boolean
C0023530 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0027947 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0002871 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0040034 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C1968707 (UMLS CUI [5])
Autoimmune Disease | Decompensated liver disease | Poorly controlled diabetes mellitus | Mental disorders | Severe chronic obstructive pulmonary disease | HIV | Hepatitis B Virus | Liver carcinoma | Malignant Neoplasms | Exception Skin carcinoma resolved | Hemoglobinopathy | Retinal Diseases | Immunosuppressed patient
Item
diagnosis of autoimmune disease, decompensated liver disease, poorly controlled diabetes mellitus, significant psychiatric illness, severe chronic obstructive pulmonary disease (copd), hiv, hepatitis b virus (hbv), hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers), hemoglobinopathy, retinal disease, or are immunosuppressed.
boolean
C0004364 (UMLS CUI [1])
C4075847 (UMLS CUI [2])
C0554876 (UMLS CUI [3])
C0004936 (UMLS CUI [4])
C0730607 (UMLS CUI [5])
C0019682 (UMLS CUI [6])
C0019169 (UMLS CUI [7])
C2239176 (UMLS CUI [8])
C0006826 (UMLS CUI [9])
C1705847 (UMLS CUI [10,1])
C0699893 (UMLS CUI [10,2])
C1514893 (UMLS CUI [10,3])
C0019045 (UMLS CUI [11])
C0035309 (UMLS CUI [12])
C0085393 (UMLS CUI [13])
Amphetamines | Cocaine | Opiates | Morphine | Heroin | Alcohol abuse | Exception Methadone Stable | Exception Buprenorphine Maintenance therapy
Item
subjects with current use of amphetamines, cocaine, opiates (e.g., morphine, heroin), or ongoing alcohol abuse are excluded. patients on stable methadone or buprenorphine maintenance treatment for at least 6 months prior to screening may be included into the study.
boolean
C0002667 (UMLS CUI [1])
C0009170 (UMLS CUI [2])
C0376196 (UMLS CUI [3])
C0026549 (UMLS CUI [4])
C0011892 (UMLS CUI [5])
C0085762 (UMLS CUI [6])
C1705847 (UMLS CUI [7,1])
C0025605 (UMLS CUI [7,2])
C0205360 (UMLS CUI [7,3])
C1705847 (UMLS CUI [8,1])
C0006405 (UMLS CUI [8,2])
C0677908 (UMLS CUI [8,3])
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