ID

121

Beschreibung

ODM derived from http://clinicaltrials.gov/show/NCT00165828

Link

http://clinicaltrials.gov/show/NCT00165828

Stichworte

Versionen (4)
  1. 02.12.11 02.12.11 -
  2. 25.03.14 25.03.14 - Martin Dugas
  3. 13.04.14 13.04.14 - Julian Varghese
  4. 13.04.14 13.04.14 - Julian Varghese
Hochgeladen am

2. Dezember 2011

DOI

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Eligibility NCT00165828 Epilepsy

Englisch

Eligibility

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria at screening
Beschreibung

Inclusion Criteria at screening

Adult aged between 18 years and 74 years
Beschreibung

Age

Datentyp

boolean

Focal epileptic seizures with or without secondary generalization
Beschreibung

Focal epileptic seizures

Datentyp

boolean

Present treatment with one or two antiepileptic drugs (constant dosage during 8 weeks baseline phase prior to initiation of treatment with zonisamide). Stimulation of the vagus nerve is permitted and will not be counted as antiepileptic drug.
Beschreibung

Present treatment with one or two antiepileptic drugs

Datentyp

boolean

For women of childbearing potential (postmenopausal for more than 1 year): possible pregnancy during the study can be excluded (by hysterectomy, sterilization or simultaneous application of two recognized methods of contraception (no oral contraceptives only)
Beschreibung

Not pregnant and contraception

Datentyp

boolean

For male patients with partners of childbearing potential: a safe method of contraception is practiced during their study participation
Beschreibung

contraception

Datentyp

boolean

Written consent to participate in the study
Beschreibung

consent

Datentyp

boolean

Inclusion criteria for randomisation
Beschreibung

Inclusion criteria for randomisation

At least 6 focal or clonicotonic seizures documented completely in a seizure diary or the patient chart during the 8 prospective or retrospective weeks baseline phase.
Beschreibung

At least 6 focal or clonicotonic seizures

Datentyp

boolean

Exclusion criteria at screening
Beschreibung

Exclusion criteria at screening

Epileptic state during the past year
Beschreibung

Epileptic state during the past year

Datentyp

boolean

Non-epileptic fits
Beschreibung

Non-epileptic fits

Datentyp

boolean

Generalized epilepsy
Beschreibung

Generalized epilepsy

Datentyp

boolean

More than 4 weeks of seizure freedom during baseline phase
Beschreibung

More than 4 weeks of seizure freedom during baseline phase

Datentyp

boolean

Concomitant progressive CNS disease including progressive myoclonus epilepsy
Beschreibung

Concomitant progressive CNS disease including progressive myoclonus epilepsy

Datentyp

boolean

Concomitant treatment with vigabatrine and / or topiramate
Beschreibung

Concomitant treatment with vigabatrine and / or topiramate

Datentyp

boolean

Hepatic and/or renal insufficiency (creatine > 2mg% or GPT > 2 times ULN)
Beschreibung

Hepatic and/or renal insufficiency

Datentyp

boolean

Body weight <= 40 kg
Beschreibung

Body weight <= 40 kg

Datentyp

boolean

(History of) kidney stones; erythrocyturia, family history (in parents, children, brothers and sisters or grandparents) of kidney stones
Beschreibung

Kidney stones

Datentyp

boolean

(History of) drug and/or alcohol dependence
Beschreibung

drug or alcohol dependence

Datentyp

boolean

Active psychosis
Beschreibung

Active psychosis

Datentyp

boolean

Suicide attempt during the past 3 years
Beschreibung

Suicide attempt during the past 3 years

Datentyp

boolean

Pre-treatment with zonisamide
Beschreibung

Pre-treatment with zonisamide

Datentyp

boolean

Known hypersensitivity to sulfonamides
Beschreibung

Known hypersensitivity to sulfonamides

Datentyp

boolean

concomitant treatment with neuroleptic drugs
Beschreibung

concomitant treatment with neuroleptic drugs

Datentyp

boolean

pregnant or breast feeding woman
Beschreibung

pregnant or breast feeding woman

Datentyp

boolean

participation in another therapy study within 3 months prior to or during this study
Beschreibung

other study

Datentyp

boolean

blood donation planned during or within 4 weeks after the participation in this study
Beschreibung

blood donation

Datentyp

boolean

elective surgery planned during the participation in this study
Beschreibung

elective surgery planned

Datentyp

boolean

patient is not willing or not capable to meet the study demands
Beschreibung

patient is not willing or not capable to meet the study demands

Datentyp

boolean

patient does not agree to the forwarding of his/her pseudonymous data
Beschreibung

patient does not agree to the forwarding of his/her pseudonymous data

Datentyp

boolean

patient without legal competence
Beschreibung

patient without legal competence

Datentyp

boolean

Exclusion criteria for randomisation
Beschreibung

Exclusion criteria for randomisation

More than 4 consecutive weeks of freedom from seizure during baseline phase
Beschreibung

More than 4 consecutive weeks of freedom from seizure during baseline phase

Datentyp

boolean

Medical concepts
Beschreibung

Medical concepts

Age
Beschreibung

Age

Datentyp

string

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
102518004
Epilepsia
Beschreibung

Epilepsy

Datentyp

string

Alias
UMLS CUI
C0014544
SNOMED CT 2010_0731
84757009
MedDRA 13.1
10015037
LOINC Version 232
MTHU020586
ICD-10-CM Version 2010
G40.9
ICD-9-CM Version 2011
345.9
Focal epilepsy
Beschreibung

Epilepsies, Partial

Datentyp

string

Alias
UMLS CUI
C0014547
SNOMED CT 2010_0731
230381009
MedDRA 13.1
10065337
Medication
Beschreibung

Pharmaceutical Preparations

Datentyp

string

Alias
UMLS CUI
C0013227
Anticonvulsant
Beschreibung

Antiepileptic Agents

Datentyp

string

Alias
UMLS CUI
C0003299
SNOMED CT 2010_0731
255632006
LOINC Version 232
MTHU006781
pregnant
Beschreibung

pregnant

Datentyp

string

Alias
UMLS CUI
C0549206
MedDRA 13.1
10036586
Contraception
Beschreibung

Contraception

Datentyp

string

Alias
UMLS CUI
C0700589
SNOMED CT 2010_0731
146680009
MedDRA 13.1
10010808
Informed Consent
Beschreibung

Informed Consent

Datentyp

string

Alias
UMLS CUI
C0021430
Convulsion
Beschreibung

Seizures

Datentyp

string

Alias
UMLS CUI
C0036572
SNOMED CT 2010_0731
91175000
MedDRA 13.1
10039910
ICD-9-CM Version 2011
780.39
Epileptic state
Beschreibung

Status Epilepticus

Datentyp

string

Alias
UMLS CUI
C0038220
SNOMED CT 2010_0731
230456007
MedDRA 13.1
10041962
ICD-10-CM Version 2010
G41
Generalized epilepsy
Beschreibung

Epilepsy, Generalized

Datentyp

string

Alias
UMLS CUI
C0014548
SNOMED CT 2010_0731
19598007
Creatinine
Beschreibung

Creatinine

Datentyp

string

Alias
UMLS CUI
C0010294
SNOMED CT 2010_0731
15373003
MedDRA 13.1
10011358
LOINC Version 232
38483-4
GPT (Serum)
Beschreibung

ALT

Datentyp

string

Alias
UMLS CUI
C0001899
SNOMED CT 2010_0731
56935002
MedDRA 13.1
10001844
Weight
Beschreibung

Weight

Datentyp

string

Alias
UMLS CUI
C1305866
SNOMED CT 2010_0731
107647005
MedDRA 13.1
10047890
LOINC Version 232
LP18015-5
Kidney stones
Beschreibung

Kidney Calculi

Datentyp

string

Alias
UMLS CUI
C0022650
SNOMED CT 2010_0731
95570007
MedDRA 13.1
10023436
ICD-10-CM Version 2010
N20.0
ICD-9-CM Version 2011
592.0
CTCAE Version 4.03
E13018
Alcohol abuse
Beschreibung

Alcohol abuse

Datentyp

string

Alias
UMLS CUI
C0085762
SNOMED CT 2010_0731
15167005
MedDRA 13.1
10001584
LOINC Version 232
LP36309-0
ICD-10-CM Version 2010
F10.1
ICD-9-CM Version 2011
305.0
Drug abuse
Beschreibung

Drug abuse

Datentyp

string

Alias
UMLS CUI
C0013146
SNOMED CT 2010_0731
26416006
MedDRA 13.1
10013654
LOINC Version 232
LP36310-8
ICD-9-CM Version 2011
305.90
Psychosis (Psychotic disorder)
Beschreibung

Psychotic Disorders

Datentyp

string

Alias
UMLS CUI
C0033975
SNOMED CT 2010_0731
69322001
MedDRA 13.1
10061920
ICD-9-CM Version 2011
290-299.99
CTCAE Version 4.03
E12954
Attempted Suicide
Beschreibung

Suicide attempt

Datentyp

string

Alias
UMLS CUI
C0038663
SNOMED CT 2010_0731
82313006
MedDRA 13.1
10042464
ICD-10-CM Version 2010
T14.91
CTCAE Version 4.03
E12969
Hypersensitivity
Beschreibung

Allergy

Datentyp

string

Alias
UMLS CUI
C0020517
SNOMED CT 2010_0731
257550005
ICD-10-CM Version 2010
T78.40
Sulfonamide
Beschreibung

Sulfonamides

Datentyp

string

Alias
UMLS CUI
C0038760
SNOMED CT 2010_0731
387406002
LOINC Version 232
MTHU007722
Neuroleptic drug
Beschreibung

Antipsychotic Agent

Datentyp

string

Alias
UMLS CUI
C0040615
SNOMED CT 2010_0731
10784006
LOINC Version 232
MTHU003337
pregnant
Beschreibung

pregnant

Datentyp

string

Alias
UMLS CUI
C0549206
MedDRA 13.1
10036586
Breast feeding, Nursing
Beschreibung

Lactation

Datentyp

string

Alias
UMLS CUI
C0006147
MedDRA 13.1
10006247
Enrollment
Beschreibung

Enrollment

Datentyp

string

Alias
UMLS CUI
C1516879
Optional surgery
Beschreibung

Elective Surgical Procedure

Datentyp

string

Alias
UMLS CUI
C0206058
SNOMED CT 2010_0731
274075007
MedDRA 13.1
10058829
Compliance
Beschreibung

Compliance

Datentyp

string

Alias
UMLS CUI
C1321605
SNOMED CT 2010_0731
405078008
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Ähnliche Modelle

Eligibility

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Inclusion Criteria at screening
Age
Item
Adult aged between 18 years and 74 years
boolean
Focal epileptic seizures
Item
Focal epileptic seizures with or without secondary generalization
boolean
Present treatment with one or two antiepileptic drugs
Item
Present treatment with one or two antiepileptic drugs (constant dosage during 8 weeks baseline phase prior to initiation of treatment with zonisamide). Stimulation of the vagus nerve is permitted and will not be counted as antiepileptic drug.
boolean
Not pregnant and contraception
Item
For women of childbearing potential (postmenopausal for more than 1 year): possible pregnancy during the study can be excluded (by hysterectomy, sterilization or simultaneous application of two recognized methods of contraception (no oral contraceptives only)
boolean
contraception
Item
For male patients with partners of childbearing potential: a safe method of contraception is practiced during their study participation
boolean
consent
Item
Written consent to participate in the study
boolean
Item Group
Inclusion criteria for randomisation
At least 6 focal or clonicotonic seizures
Item
At least 6 focal or clonicotonic seizures documented completely in a seizure diary or the patient chart during the 8 prospective or retrospective weeks baseline phase.
boolean
Item Group
Exclusion criteria at screening
Epileptic state during the past year
Item
Epileptic state during the past year
boolean
Non-epileptic fits
Item
Non-epileptic fits
boolean
Generalized epilepsy
Item
Generalized epilepsy
boolean
More than 4 weeks of seizure freedom during baseline phase
Item
More than 4 weeks of seizure freedom during baseline phase
boolean
Concomitant progressive CNS disease including progressive myoclonus epilepsy
Item
Concomitant progressive CNS disease including progressive myoclonus epilepsy
boolean
Concomitant treatment with vigabatrine and / or topiramate
Item
Concomitant treatment with vigabatrine and / or topiramate
boolean
Hepatic and/or renal insufficiency
Item
Hepatic and/or renal insufficiency (creatine > 2mg% or GPT > 2 times ULN)
boolean
Body weight <= 40 kg
Item
Body weight <= 40 kg
boolean
Kidney stones
Item
(History of) kidney stones; erythrocyturia, family history (in parents, children, brothers and sisters or grandparents) of kidney stones
boolean
drug or alcohol dependence
Item
(History of) drug and/or alcohol dependence
boolean
Active psychosis
Item
Active psychosis
boolean
Suicide attempt during the past 3 years
Item
Suicide attempt during the past 3 years
boolean
Pre-treatment with zonisamide
Item
Pre-treatment with zonisamide
boolean
Known hypersensitivity to sulfonamides
Item
Known hypersensitivity to sulfonamides
boolean
concomitant treatment with neuroleptic drugs
Item
concomitant treatment with neuroleptic drugs
boolean
pregnant or breast feeding woman
Item
pregnant or breast feeding woman
boolean
other study
Item
participation in another therapy study within 3 months prior to or during this study
boolean
blood donation
Item
blood donation planned during or within 4 weeks after the participation in this study
boolean
elective surgery planned
Item
elective surgery planned during the participation in this study
boolean
patient is not willing or not capable to meet the study demands
Item
patient is not willing or not capable to meet the study demands
boolean
patient does not agree to the forwarding of his/her pseudonymous data
Item
patient does not agree to the forwarding of his/her pseudonymous data
boolean
patient without legal competence
Item
patient without legal competence
boolean
Item Group
Exclusion criteria for randomisation
More than 4 consecutive weeks of freedom from seizure during baseline phase
Item
More than 4 consecutive weeks of freedom from seizure during baseline phase
boolean
Item Group
Medical concepts
Age
Item
Age
string
C0001779 (UMLS CUI)
102518004 (SNOMED CT 2010_0731)
Epilepsy
Item
Epilepsia
string
C0014544 (UMLS CUI)
84757009 (SNOMED CT 2010_0731)
10015037 (MedDRA 13.1)
MTHU020586 (LOINC Version 232)
G40.9 (ICD-10-CM Version 2010)
345.9 (ICD-9-CM Version 2011)
Epilepsies, Partial
Item
Focal epilepsy
string
C0014547 (UMLS CUI)
230381009 (SNOMED CT 2010_0731)
10065337 (MedDRA 13.1)
Pharmaceutical Preparations
Item
Medication
string
C0013227 (UMLS CUI)
Antiepileptic Agents
Item
Anticonvulsant
string
C0003299 (UMLS CUI)
255632006 (SNOMED CT 2010_0731)
MTHU006781 (LOINC Version 232)
pregnant
Item
pregnant
string
C0549206 (UMLS CUI)
10036586 (MedDRA 13.1)
Contraception
Item
Contraception
string
C0700589 (UMLS CUI)
146680009 (SNOMED CT 2010_0731)
10010808 (MedDRA 13.1)
Informed Consent
Item
Informed Consent
string
C0021430 (UMLS CUI)
Seizures
Item
Convulsion
string
C0036572 (UMLS CUI)
91175000 (SNOMED CT 2010_0731)
10039910 (MedDRA 13.1)
780.39 (ICD-9-CM Version 2011)
Status Epilepticus
Item
Epileptic state
string
C0038220 (UMLS CUI)
230456007 (SNOMED CT 2010_0731)
10041962 (MedDRA 13.1)
G41 (ICD-10-CM Version 2010)
Epilepsy, Generalized
Item
Generalized epilepsy
string
C0014548 (UMLS CUI)
19598007 (SNOMED CT 2010_0731)
Creatinine
Item
Creatinine
string
C0010294 (UMLS CUI)
15373003 (SNOMED CT 2010_0731)
10011358 (MedDRA 13.1)
38483-4 (LOINC Version 232)
ALT
Item
GPT (Serum)
string
C0001899 (UMLS CUI)
56935002 (SNOMED CT 2010_0731)
10001844 (MedDRA 13.1)
Weight
Item
Weight
string
C1305866 (UMLS CUI)
107647005 (SNOMED CT 2010_0731)
10047890 (MedDRA 13.1)
LP18015-5 (LOINC Version 232)
Kidney Calculi
Item
Kidney stones
string
C0022650 (UMLS CUI)
95570007 (SNOMED CT 2010_0731)
10023436 (MedDRA 13.1)
N20.0 (ICD-10-CM Version 2010)
592.0 (ICD-9-CM Version 2011)
E13018 (CTCAE Version 4.03)
Alcohol abuse
Item
Alcohol abuse
string
C0085762 (UMLS CUI)
15167005 (SNOMED CT 2010_0731)
10001584 (MedDRA 13.1)
LP36309-0 (LOINC Version 232)
F10.1 (ICD-10-CM Version 2010)
305.0 (ICD-9-CM Version 2011)
Drug abuse
Item
Drug abuse
string
C0013146 (UMLS CUI)
26416006 (SNOMED CT 2010_0731)
10013654 (MedDRA 13.1)
LP36310-8 (LOINC Version 232)
305.90 (ICD-9-CM Version 2011)
Psychotic Disorders
Item
Psychosis (Psychotic disorder)
string
C0033975 (UMLS CUI)
69322001 (SNOMED CT 2010_0731)
10061920 (MedDRA 13.1)
290-299.99 (ICD-9-CM Version 2011)
E12954 (CTCAE Version 4.03)
Suicide attempt
Item
Attempted Suicide
string
C0038663 (UMLS CUI)
82313006 (SNOMED CT 2010_0731)
10042464 (MedDRA 13.1)
T14.91 (ICD-10-CM Version 2010)
E12969 (CTCAE Version 4.03)
Allergy
Item
Hypersensitivity
string
C0020517 (UMLS CUI)
257550005 (SNOMED CT 2010_0731)
T78.40 (ICD-10-CM Version 2010)
Sulfonamides
Item
Sulfonamide
string
C0038760 (UMLS CUI)
387406002 (SNOMED CT 2010_0731)
MTHU007722 (LOINC Version 232)
Antipsychotic Agent
Item
Neuroleptic drug
string
C0040615 (UMLS CUI)
10784006 (SNOMED CT 2010_0731)
MTHU003337 (LOINC Version 232)
pregnant
Item
pregnant
string
C0549206 (UMLS CUI)
10036586 (MedDRA 13.1)
Lactation
Item
Breast feeding, Nursing
string
C0006147 (UMLS CUI)
10006247 (MedDRA 13.1)
Enrollment
Item
Enrollment
string
C1516879 (UMLS CUI)
Elective Surgical Procedure
Item
Optional surgery
string
C0206058 (UMLS CUI)
274075007 (SNOMED CT 2010_0731)
10058829 (MedDRA 13.1)
Compliance
Item
Compliance
string
C1321605 (UMLS CUI)
405078008 (SNOMED CT 2010_0731)
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