ID

31771

Beschreibung

Flupirtine as Oral Treatment in Multiple Sclerosis; ODM derived from: https://clinicaltrials.gov/show/NCT00623415

Link

https://clinicaltrials.gov/show/NCT00623415

Stichworte

Versionen (1)
  1. 27.09.18 27.09.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

27. September 2018

DOI

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Eligibility Relapsing Remitting Multiple Sclerosis NCT00623415

Englisch

Eligibility Relapsing Remitting Multiple Sclerosis NCT00623415

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
relapsing-remitting ms according to the revised mcdonald-criteria (2005)
Beschreibung

Multiple Sclerosis, Relapsing-Remitting

Datentyp

boolean

Alias
UMLS CUI [1]
C0751967
edss ≤ 4.0
Beschreibung

EDSS

Datentyp

boolean

Alias
UMLS CUI [1]
C0451246
stable treatment with interferon-β1b for at least 6 months
Beschreibung

Interferon beta-1b Stable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0244713
UMLS CUI [1,2]
C0205360
sufficient birth control (pearl-index <1)
Beschreibung

Contraceptive methods | Other Coding

Datentyp

boolean

Alias
UMLS CUI [1]
C0700589
UMLS CUI [2]
C3846158
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
any other ms-course than rrms
Beschreibung

Multiple Sclerosis Except Relapsing-Remitting Multiple Sclerosis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0026769
UMLS CUI [1,2]
C0332300
UMLS CUI [1,3]
C0751967
clinically relevant gastrointestinal disease
Beschreibung

Gastrointestinal Diseases

Datentyp

boolean

Alias
UMLS CUI [1]
C0017178
clinically relevant pulmonary, cardiological, infectious or cns-disease
Beschreibung

Lung disease | Heart Disease | Communicable Disease | CNS disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C0024115
UMLS CUI [2]
C0018799
UMLS CUI [3]
C0009450
UMLS CUI [4]
C0007682
clinically relevant disease of liver or bile system, pathological value for transaminases, gamma-gt or bilirubin.
Beschreibung

Liver disease | Bile Duct Disease | Transaminases abnormal | Gamma-GT abnormal | Bilirubin abnormal

Datentyp

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0005395
UMLS CUI [3]
C1328397
UMLS CUI [4]
C0541979
UMLS CUI [5]
C1142335
hepatitis (except uncomplicated hepatitis a with complete remission
Beschreibung

Hepatitis | Exception Hepatitis A Uncomplicated In complete remission

Datentyp

boolean

Alias
UMLS CUI [1]
C0019158
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0019159
UMLS CUI [2,3]
C0443334
UMLS CUI [2,4]
C0677874
clinically relevant dysfunction of kidneys (creatinine >180 µmol/l) or bone marrow (hb < 8.5 g/dl, wbc < 2.5/nl thrombocytes < 125/nl)
Beschreibung

Renal dysfunction | Creatinine measurement, serum | Bone Marrow Dysfunction | Hemoglobin measurement | White Blood Cell Count procedure | Platelet Count measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C3279454
UMLS CUI [2]
C0201976
UMLS CUI [3,1]
C0005953
UMLS CUI [3,2]
C3887504
UMLS CUI [4]
C0518015
UMLS CUI [5]
C0023508
UMLS CUI [6]
C0032181
myasthenia gravis
Beschreibung

Myasthenia Gravis

Datentyp

boolean

Alias
UMLS CUI [1]
C0026896
oral anticoagulation (phenprocoumon)
Beschreibung

Oral anticoagulants | Phenprocoumon

Datentyp

boolean

Alias
UMLS CUI [1]
C0354604
UMLS CUI [2]
C0031444
treatment with carbamazepine or paracetamol
Beschreibung

Carbamazepine | Paracetamol

Datentyp

boolean

Alias
UMLS CUI [1]
C0006949
UMLS CUI [2]
C0000970
drug or alcohol abuse
Beschreibung

Substance Use Disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
pregnancy or lactation period
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
treatment at any time before or during study with complete lymphoradiation, monoclonal antibodies (e.g. anti-cd4, campath 1h, natalizumab), mitoxantrone, cyclophosphamide, cyclosporin, azathioprine
Beschreibung

Lymphatic Radiation Therapy Complete | Monoclonal Antibody Therapy | Anti-CD4 Monoclonal Antibody | Campath 1H | natalizumab | Mitoxantrone | Cyclophosphamide | Cyclosporine | Azathioprine

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0086572
UMLS CUI [1,2]
C0205197
UMLS CUI [2]
C0279694
UMLS CUI [3]
C3831519
UMLS CUI [4]
C1178562
UMLS CUI [5]
C1172734
UMLS CUI [6]
C0026259
UMLS CUI [7]
C0010583
UMLS CUI [8]
C0010592
UMLS CUI [9]
C0004482
treatment within 6 months before randomization with any other immunomodulatory substance than interferon-β1b or intravenous methylprednisolone
Beschreibung

Biological Response Modifiers | Exception Interferon beta-1b | Exception Methylprednisolone Intravenous

Datentyp

boolean

Alias
UMLS CUI [1]
C0005525
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0244713
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0025815
UMLS CUI [3,3]
C1522726
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Ähnliche Modelle

Eligibility Relapsing Remitting Multiple Sclerosis NCT00623415

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Sclerosis, Relapsing-Remitting
Item
relapsing-remitting ms according to the revised mcdonald-criteria (2005)
boolean
C0751967 (UMLS CUI [1])
EDSS
Item
edss ≤ 4.0
boolean
C0451246 (UMLS CUI [1])
Interferon beta-1b Stable
Item
stable treatment with interferon-β1b for at least 6 months
boolean
C0244713 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
Contraceptive methods | Other Coding
Item
sufficient birth control (pearl-index <1)
boolean
C0700589 (UMLS CUI [1])
C3846158 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Multiple Sclerosis Except Relapsing-Remitting Multiple Sclerosis
Item
any other ms-course than rrms
boolean
C0026769 (UMLS CUI [1,1])
C0332300 (UMLS CUI [1,2])
C0751967 (UMLS CUI [1,3])
Gastrointestinal Diseases
Item
clinically relevant gastrointestinal disease
boolean
C0017178 (UMLS CUI [1])
Lung disease | Heart Disease | Communicable Disease | CNS disorder
Item
clinically relevant pulmonary, cardiological, infectious or cns-disease
boolean
C0024115 (UMLS CUI [1])
C0018799 (UMLS CUI [2])
C0009450 (UMLS CUI [3])
C0007682 (UMLS CUI [4])
Liver disease | Bile Duct Disease | Transaminases abnormal | Gamma-GT abnormal | Bilirubin abnormal
Item
clinically relevant disease of liver or bile system, pathological value for transaminases, gamma-gt or bilirubin.
boolean
C0023895 (UMLS CUI [1])
C0005395 (UMLS CUI [2])
C1328397 (UMLS CUI [3])
C0541979 (UMLS CUI [4])
C1142335 (UMLS CUI [5])
Hepatitis | Exception Hepatitis A Uncomplicated In complete remission
Item
hepatitis (except uncomplicated hepatitis a with complete remission
boolean
C0019158 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0019159 (UMLS CUI [2,2])
C0443334 (UMLS CUI [2,3])
C0677874 (UMLS CUI [2,4])
Renal dysfunction | Creatinine measurement, serum | Bone Marrow Dysfunction | Hemoglobin measurement | White Blood Cell Count procedure | Platelet Count measurement
Item
clinically relevant dysfunction of kidneys (creatinine >180 µmol/l) or bone marrow (hb < 8.5 g/dl, wbc < 2.5/nl thrombocytes < 125/nl)
boolean
C3279454 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0005953 (UMLS CUI [3,1])
C3887504 (UMLS CUI [3,2])
C0518015 (UMLS CUI [4])
C0023508 (UMLS CUI [5])
C0032181 (UMLS CUI [6])
Myasthenia Gravis
Item
myasthenia gravis
boolean
C0026896 (UMLS CUI [1])
Oral anticoagulants | Phenprocoumon
Item
oral anticoagulation (phenprocoumon)
boolean
C0354604 (UMLS CUI [1])
C0031444 (UMLS CUI [2])
Carbamazepine | Paracetamol
Item
treatment with carbamazepine or paracetamol
boolean
C0006949 (UMLS CUI [1])
C0000970 (UMLS CUI [2])
Substance Use Disorders
Item
drug or alcohol abuse
boolean
C0038586 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnancy or lactation period
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Lymphatic Radiation Therapy Complete | Monoclonal Antibody Therapy | Anti-CD4 Monoclonal Antibody | Campath 1H | natalizumab | Mitoxantrone | Cyclophosphamide | Cyclosporine | Azathioprine
Item
treatment at any time before or during study with complete lymphoradiation, monoclonal antibodies (e.g. anti-cd4, campath 1h, natalizumab), mitoxantrone, cyclophosphamide, cyclosporin, azathioprine
boolean
C0086572 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0279694 (UMLS CUI [2])
C3831519 (UMLS CUI [3])
C1178562 (UMLS CUI [4])
C1172734 (UMLS CUI [5])
C0026259 (UMLS CUI [6])
C0010583 (UMLS CUI [7])
C0010592 (UMLS CUI [8])
C0004482 (UMLS CUI [9])
Biological Response Modifiers | Exception Interferon beta-1b | Exception Methylprednisolone Intravenous
Item
treatment within 6 months before randomization with any other immunomodulatory substance than interferon-β1b or intravenous methylprednisolone
boolean
C0005525 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0244713 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0025815 (UMLS CUI [3,2])
C1522726 (UMLS CUI [3,3])
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