ID

15767

Beschrijving

Treatment of Multiple Sclerosis Using Over the Counter Inosine; ODM derived from: https://clinicaltrials.gov/show/NCT00067327

Link

https://clinicaltrials.gov/show/NCT00067327

Trefwoorden

Versies (1)
  1. 12-06-16 12-06-16 -
Geüploaded op

12 juni 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis, Relapsing-Remitting NCT00067327

Engels

Eligibility Multiple Sclerosis, Relapsing-Remitting NCT00067327

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
nonpregnant, nonlactating females
Beschrijving

pregnancy or breast-feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
females of child bearing potential must have a negative human chorionic gonadotropin (hcg) test result within 60 days before the first dose of study material.
Beschrijving

HCG test

Datatype

boolean

Alias
UMLS CUI [1]
C0546577
males and females must practice adequate contraception, in the judgement of the investigator, during the course of the study.
Beschrijving

contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1]
C0700589
subjects must have a diagnosis of clinically definite relapsing remitting multiple sclerosis based on medical history, physical examination, laboratory test results, and neurologic examination. alternatively, subjects may have clinically probable ms characterized by 1 attack and the presence of at least 4 lesions on mri within 12 months before the initial baseline evaluation.
Beschrijving

relapsing remitting multiple sclerosis

Datatype

boolean

Alias
UMLS CUI [1]
C0751967
subjects must have an expanded disability status scale (edss) test result of less than or equal to 5.0 within 60 days before the first dose of study material.
Beschrijving

EDSS

Datatype

boolean

Alias
UMLS CUI [1]
C0451246
subjects will have serum uric acid levels less than 5 mg/dl.
Beschrijving

serum uric acid level

Datatype

boolean

Alias
UMLS CUI [1,1]
C0041980
UMLS CUI [1,2]
C0229671
have 1 clinical relapse in the last year
Beschrijving

clinical relapse

Datatype

boolean

Alias
UMLS CUI [1]
C0856120
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
presence of any medical disability or laboratory test result that, in the judgement of the investigator, would interfere with assessment of the tolerability, safety, or efficacy of study material or would compromise the subject's ability to provide informed consent.
Beschrijving

comorbidity

Datatype

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
UMLS CUI [2]
C0009488
evidence of active infection characterized by requiring treatment with antibiotics within 7 days before the first dose of study material.
Beschrijving

evidence of active infection

Datatype

boolean

Alias
UMLS CUI [1]
C0009450
treatment with interferons, glatiramer acetate, lymphoid irradiation, cyclophosphamide, or with other immune modifying treatments within 3 months, or corticosteroids within 1 month before the initial baseline mri assessment in this trial.
Beschrijving

treatment

Datatype

boolean

Alias
UMLS CUI [1]
C0021747
UMLS CUI [2]
C0289884
UMLS CUI [3]
C0024230
UMLS CUI [4]
C0010583
recent history (within the previous 2 years) of drug or alcohol abuse.
Beschrijving

drug or alcohol abuse

Datatype

boolean

Alias
UMLS CUI [1]
C0038586
known allergy to inosine products or history of anaphylaxis.
Beschrijving

allergy to inosine

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0021528
UMLS CUI [2]
C0002792
previous randomization into this study.
Beschrijving

previous randomization

Datatype

boolean

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0205156
treatment with an investigational agent within 30 days before the first dose of study material.
Beschrijving

treatment with an investigational agent

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Multiple Sclerosis, Relapsing-Remitting NCT00067327

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
pregnancy or breast-feeding
Item
nonpregnant, nonlactating females
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
HCG test
Item
females of child bearing potential must have a negative human chorionic gonadotropin (hcg) test result within 60 days before the first dose of study material.
boolean
C0546577 (UMLS CUI [1])
contraceptive methods
Item
males and females must practice adequate contraception, in the judgement of the investigator, during the course of the study.
boolean
C0700589 (UMLS CUI [1])
relapsing remitting multiple sclerosis
Item
subjects must have a diagnosis of clinically definite relapsing remitting multiple sclerosis based on medical history, physical examination, laboratory test results, and neurologic examination. alternatively, subjects may have clinically probable ms characterized by 1 attack and the presence of at least 4 lesions on mri within 12 months before the initial baseline evaluation.
boolean
C0751967 (UMLS CUI [1])
EDSS
Item
subjects must have an expanded disability status scale (edss) test result of less than or equal to 5.0 within 60 days before the first dose of study material.
boolean
C0451246 (UMLS CUI [1])
serum uric acid level
Item
subjects will have serum uric acid levels less than 5 mg/dl.
boolean
C0041980 (UMLS CUI [1,1])
C0229671 (UMLS CUI [1,2])
clinical relapse
Item
have 1 clinical relapse in the last year
boolean
C0856120 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
comorbidity
Item
presence of any medical disability or laboratory test result that, in the judgement of the investigator, would interfere with assessment of the tolerability, safety, or efficacy of study material or would compromise the subject's ability to provide informed consent.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2])
evidence of active infection
Item
evidence of active infection characterized by requiring treatment with antibiotics within 7 days before the first dose of study material.
boolean
C0009450 (UMLS CUI [1])
treatment
Item
treatment with interferons, glatiramer acetate, lymphoid irradiation, cyclophosphamide, or with other immune modifying treatments within 3 months, or corticosteroids within 1 month before the initial baseline mri assessment in this trial.
boolean
C0021747 (UMLS CUI [1])
C0289884 (UMLS CUI [2])
C0024230 (UMLS CUI [3])
C0010583 (UMLS CUI [4])
drug or alcohol abuse
Item
recent history (within the previous 2 years) of drug or alcohol abuse.
boolean
C0038586 (UMLS CUI [1])
allergy to inosine
Item
known allergy to inosine products or history of anaphylaxis.
boolean
C0020517 (UMLS CUI [1,1])
C0021528 (UMLS CUI [1,2])
C0002792 (UMLS CUI [2])
previous randomization
Item
previous randomization into this study.
boolean
C0034656 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
treatment with an investigational agent
Item
treatment with an investigational agent within 30 days before the first dose of study material.
boolean
C2348568 (UMLS CUI [1])
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