ID

24727

Description

Efficacy and Safety Evaluation of Nabilone as Adjunctive Therapy to Gabapentin for the Management of Neuropathic Pain in Multiple Sclerosis; ODM derived from: https://clinicaltrials.gov/show/NCT00480181

Lien

https://clinicaltrials.gov/show/NCT00480181

Mots-clés

Versions (1)
  1. 15/08/2017 15/08/2017 -
Téléchargé le

15 août 2017

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Neuropathic Pain NCT00480181

Anglais

Eligibility Neuropathic Pain NCT00480181

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
males and females between the ages of 18-65 years old with clinically definite rrms
Description

Age | Multiple Sclerosis, Relapsing-Remitting

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0751967
edss of < 6.5
Description

Kurtzke multiple sclerosis rating scale

Type de données

boolean

Alias
UMLS CUI [1]
C0451246
current treatment with gabapentin that is not effective at a stabilized dose of (>1800mg/day) for at least 1 month.
Description

Gabapentin Dose Stable Ineffective

Type de données

boolean

Alias
UMLS CUI [1,1]
C0060926
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [1,4]
C3242229
visual analogue scale score for npp symptoms > 5; pain present for at least 3 months
Description

Neuropathic pain Symptoms Visual Analog Pain Scale | Neuropathic pain Duration

Type de données

boolean

Alias
UMLS CUI [1,1]
C3714625
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0042815
UMLS CUI [2,1]
C3714625
UMLS CUI [2,2]
C0449238
negative serum pregnancy test for all females of childbearing age; not currently breastfeeding
Description

Childbearing Potential Serum pregnancy test negative | Breast Feeding Absent

Type de données

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C0332197
no history of alcohol or substance abuse
Description

Substance Use Disorders Exclusion

Type de données

boolean

Alias
UMLS CUI [1,1]
C0038586
UMLS CUI [1,2]
C2828389
no history of non-psychotic emotional disorders
Description

Nonpsychotic mental disorder Exclusion

Type de données

boolean

Alias
UMLS CUI [1,1]
C0041857
UMLS CUI [1,2]
C2828389
no significant hepatic or renal insufficiency
Description

Hepatic Insufficiency Exclusion | Renal Insufficiency Exclusion

Type de données

boolean

Alias
UMLS CUI [1,1]
C1306571
UMLS CUI [1,2]
C2828389
UMLS CUI [2,1]
C1565489
UMLS CUI [2,2]
C2828389
no significant cardiovascular disease or hypertension
Description

Cardiovascular Disease Exclusion | Hypertensive disease Exclusion

Type de données

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C2828389
UMLS CUI [2,1]
C0020538
UMLS CUI [2,2]
C2828389
no known hypersensitivity and/or allergy to nabilone or its derivatives
Description

Exclusion Criteria | Nabilone allergy | Hypersensitivity Nabilone Derivative

Type de données

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2]
C0570597
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0068333
UMLS CUI [3,3]
C1527240
no current use of cannabinoid or related products
Description

Cannabinoids Exclusion | Product Related Exclusion

Type de données

boolean

Alias
UMLS CUI [1,1]
C0006864
UMLS CUI [1,2]
C2828389
UMLS CUI [2,1]
C1514468
UMLS CUI [2,2]
C0439849
UMLS CUI [2,3]
C2828389
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Similar models

Eligibility Neuropathic Pain NCT00480181

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Age | Multiple Sclerosis, Relapsing-Remitting
Item
males and females between the ages of 18-65 years old with clinically definite rrms
boolean
C0001779 (UMLS CUI [1])
C0751967 (UMLS CUI [2])
Kurtzke multiple sclerosis rating scale
Item
edss of < 6.5
boolean
C0451246 (UMLS CUI [1])
Gabapentin Dose Stable Ineffective
Item
current treatment with gabapentin that is not effective at a stabilized dose of (>1800mg/day) for at least 1 month.
boolean
C0060926 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C3242229 (UMLS CUI [1,4])
Neuropathic pain Symptoms Visual Analog Pain Scale | Neuropathic pain Duration
Item
visual analogue scale score for npp symptoms > 5; pain present for at least 3 months
boolean
C3714625 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0042815 (UMLS CUI [1,3])
C3714625 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
Childbearing Potential Serum pregnancy test negative | Breast Feeding Absent
Item
negative serum pregnancy test for all females of childbearing age; not currently breastfeeding
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Substance Use Disorders Exclusion
Item
no history of alcohol or substance abuse
boolean
C0038586 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
Nonpsychotic mental disorder Exclusion
Item
no history of non-psychotic emotional disorders
boolean
C0041857 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
Hepatic Insufficiency Exclusion | Renal Insufficiency Exclusion
Item
no significant hepatic or renal insufficiency
boolean
C1306571 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
C1565489 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
Cardiovascular Disease Exclusion | Hypertensive disease Exclusion
Item
no significant cardiovascular disease or hypertension
boolean
C0007222 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
C0020538 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
Exclusion Criteria | Nabilone allergy | Hypersensitivity Nabilone Derivative
Item
no known hypersensitivity and/or allergy to nabilone or its derivatives
boolean
C0680251 (UMLS CUI [1])
C0570597 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C0068333 (UMLS CUI [3,2])
C1527240 (UMLS CUI [3,3])
Cannabinoids Exclusion | Product Related Exclusion
Item
no current use of cannabinoid or related products
boolean
C0006864 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
C1514468 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C2828389 (UMLS CUI [2,3])
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