ID

21978

Descrição

Sativex Versus Placebo When Added to Existing Treatment for Central Neuropathic Pain in MS; ODM derived from: https://clinicaltrials.gov/show/NCT00391079

Link

https://clinicaltrials.gov/show/NCT00391079

Palavras-chave

Versões (1)
  1. 12/05/2017 12/05/2017 -
Transferido a

12 de maio de 2017

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT00391079

Inglês

Eligibility Multiple Sclerosis NCT00391079

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
any disease sub-type of ms of at least two years duration
Descrição

Multiple Sclerosis Subtype disease length

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0026769
UMLS CUI [1,2]
C0872379
UMLS CUI [1,3]
C0872146
central neuropathic pain (cnp) of at least three months and expected to remain stable for the study duration
Descrição

Neuropathic pain Central Disease length

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3714625
UMLS CUI [1,2]
C0205099
UMLS CUI [1,3]
C0872146
moderate cnp defined by nrs pain score at baseline sum to at least 24
Descrição

Neuropathic pain Central Moderate Numeric Pain Scale

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3714625
UMLS CUI [1,2]
C0205099
UMLS CUI [1,3]
C0205081
UMLS CUI [1,4]
C1518471
subject established on or previously tried and failed analgesic therapy for cnp
Descrição

Analgesic therapy Neuropathic pain Central | Analgesic therapy Previous failed

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0412784
UMLS CUI [1,2]
C3714625
UMLS CUI [1,3]
C0205099
UMLS CUI [2,1]
C0412784
UMLS CUI [2,2]
C0205156
UMLS CUI [2,3]
C0231175
if receiving disease modifying medications, stable dose for 3 months and maintained for study duration
Descrição

Pharmaceutical Preparations Disease Modification | Pharmaceutical Preparations Dose Stable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0392747
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects whose identified pain is likely to be nociceptive, musculoskeletal (including spasms) peripheral neuropathic or psychogenic in origin, or due to trigeminal neuralgia.
Descrição

Nociceptive Pain | Musculoskeletal Pain | Spasm | Peripheral neuropathic pain | Somatoform pain disorder | Pain Due to Trigeminal Neuralgia

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3178766
UMLS CUI [2]
C0026858
UMLS CUI [3]
C0037763
UMLS CUI [4]
C0458960
UMLS CUI [5]
C0152174
UMLS CUI [6,1]
C0030193
UMLS CUI [6,2]
C0678226
UMLS CUI [6,3]
C0040997
other non central neuropathic pain of a severity which is likely to interfere with the patients assessment of cnp
Descrição

Neuropathic pain Severe | Neuropathic pain Interferes with Assessment Neuropathic pain central

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3714625
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C3714625
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C1516048
UMLS CUI [2,4]
C3714625
UMLS CUI [2,5]
C0205099
medical history suggests subject is likely to relapse/remit during course of study
Descrição

Relapsing-remitting course Probably

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3808177
UMLS CUI [1,2]
C0750492
history of schizophrenia (including family history), other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with ms
Descrição

Schizophrenia | FH: Schizophrenia | Psychotic Disorder | Personality Disorder Severe | Mental disorders | Depressive disorder Associated with Multiple Sclerosis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0036341
UMLS CUI [2]
C0455382
UMLS CUI [3]
C0033975
UMLS CUI [4,1]
C0031212
UMLS CUI [4,2]
C0205082
UMLS CUI [5]
C0004936
UMLS CUI [6,1]
C0011581
UMLS CUI [6,2]
C0332281
UMLS CUI [6,3]
C0026769
known or suspected history of alcohol abuse, epilepsy or recurrent seizures or hypersensitivity to cannabinoids
Descrição

Alcohol abuse | Epilepsy | Recurrent seizures | Hypersensitivity Cannabinoids

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0085762
UMLS CUI [2]
C0014544
UMLS CUI [3]
C0748607
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0006864
travel outside of the country of residence planned during the study
Descrição

Travel Planned

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0040802
UMLS CUI [1,2]
C1301732
significant cardiac, renal or hepatic impairment
Descrição

Heart failure | Renal Insufficiency | Hepatic impairment

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0018801
UMLS CUI [2]
C1565489
UMLS CUI [3]
C0948807
subjects with current recreational cannabis, medicinal cannabis or synthetic cannabinoid based medications within 3 months prior to study entry and unwilling to abstain for the duration of the study
Descrição

Marihuana Recreational | Medical Marijuana | Pharmaceutical Preparations Cannabinoids Based | Drug Abstinence Unwilling

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0024808
UMLS CUI [1,2]
C0242508
UMLS CUI [2]
C0813973
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C0006864
UMLS CUI [3,3]
C1705938
UMLS CUI [4,1]
C0237443
UMLS CUI [4,2]
C0558080
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Similar models

Eligibility Multiple Sclerosis NCT00391079

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Sclerosis Subtype disease length
Item
any disease sub-type of ms of at least two years duration
boolean
C0026769 (UMLS CUI [1,1])
C0872379 (UMLS CUI [1,2])
C0872146 (UMLS CUI [1,3])
Neuropathic pain Central Disease length
Item
central neuropathic pain (cnp) of at least three months and expected to remain stable for the study duration
boolean
C3714625 (UMLS CUI [1,1])
C0205099 (UMLS CUI [1,2])
C0872146 (UMLS CUI [1,3])
Neuropathic pain Central Moderate Numeric Pain Scale
Item
moderate cnp defined by nrs pain score at baseline sum to at least 24
boolean
C3714625 (UMLS CUI [1,1])
C0205099 (UMLS CUI [1,2])
C0205081 (UMLS CUI [1,3])
C1518471 (UMLS CUI [1,4])
Analgesic therapy Neuropathic pain Central | Analgesic therapy Previous failed
Item
subject established on or previously tried and failed analgesic therapy for cnp
boolean
C0412784 (UMLS CUI [1,1])
C3714625 (UMLS CUI [1,2])
C0205099 (UMLS CUI [1,3])
C0412784 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C0231175 (UMLS CUI [2,3])
Pharmaceutical Preparations Disease Modification | Pharmaceutical Preparations Dose Stable
Item
if receiving disease modifying medications, stable dose for 3 months and maintained for study duration
boolean
C0013227 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0392747 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Nociceptive Pain | Musculoskeletal Pain | Spasm | Peripheral neuropathic pain | Somatoform pain disorder | Pain Due to Trigeminal Neuralgia
Item
subjects whose identified pain is likely to be nociceptive, musculoskeletal (including spasms) peripheral neuropathic or psychogenic in origin, or due to trigeminal neuralgia.
boolean
C3178766 (UMLS CUI [1])
C0026858 (UMLS CUI [2])
C0037763 (UMLS CUI [3])
C0458960 (UMLS CUI [4])
C0152174 (UMLS CUI [5])
C0030193 (UMLS CUI [6,1])
C0678226 (UMLS CUI [6,2])
C0040997 (UMLS CUI [6,3])
Neuropathic pain Severe | Neuropathic pain Interferes with Assessment Neuropathic pain central
Item
other non central neuropathic pain of a severity which is likely to interfere with the patients assessment of cnp
boolean
C3714625 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C3714625 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C1516048 (UMLS CUI [2,3])
C3714625 (UMLS CUI [2,4])
C0205099 (UMLS CUI [2,5])
Relapsing-remitting course Probably
Item
medical history suggests subject is likely to relapse/remit during course of study
boolean
C3808177 (UMLS CUI [1,1])
C0750492 (UMLS CUI [1,2])
Schizophrenia | FH: Schizophrenia | Psychotic Disorder | Personality Disorder Severe | Mental disorders | Depressive disorder Associated with Multiple Sclerosis
Item
history of schizophrenia (including family history), other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with ms
boolean
C0036341 (UMLS CUI [1])
C0455382 (UMLS CUI [2])
C0033975 (UMLS CUI [3])
C0031212 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0004936 (UMLS CUI [5])
C0011581 (UMLS CUI [6,1])
C0332281 (UMLS CUI [6,2])
C0026769 (UMLS CUI [6,3])
Alcohol abuse | Epilepsy | Recurrent seizures | Hypersensitivity Cannabinoids
Item
known or suspected history of alcohol abuse, epilepsy or recurrent seizures or hypersensitivity to cannabinoids
boolean
C0085762 (UMLS CUI [1])
C0014544 (UMLS CUI [2])
C0748607 (UMLS CUI [3])
C0020517 (UMLS CUI [4,1])
C0006864 (UMLS CUI [4,2])
Travel Planned
Item
travel outside of the country of residence planned during the study
boolean
C0040802 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Heart failure | Renal Insufficiency | Hepatic impairment
Item
significant cardiac, renal or hepatic impairment
boolean
C0018801 (UMLS CUI [1])
C1565489 (UMLS CUI [2])
C0948807 (UMLS CUI [3])
Marihuana Recreational | Medical Marijuana | Pharmaceutical Preparations Cannabinoids Based | Drug Abstinence Unwilling
Item
subjects with current recreational cannabis, medicinal cannabis or synthetic cannabinoid based medications within 3 months prior to study entry and unwilling to abstain for the duration of the study
boolean
C0024808 (UMLS CUI [1,1])
C0242508 (UMLS CUI [1,2])
C0813973 (UMLS CUI [2])
C0013227 (UMLS CUI [3,1])
C0006864 (UMLS CUI [3,2])
C1705938 (UMLS CUI [3,3])
C0237443 (UMLS CUI [4,1])
C0558080 (UMLS CUI [4,2])
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