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

Link

https://clinicaltrials.gov/show/NCT00480181

Keywords

Versions (1)
  1. 8/15/17 8/15/17 -
Uploaded on

August 15, 2017

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Neuropathic Pain NCT00480181

English

Eligibility Neuropathic Pain NCT00480181

1 forms  
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

Data type

boolean

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

Kurtzke multiple sclerosis rating scale

Data type

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

Data type

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

Data type

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

Data type

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

Data type

boolean

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

Nonpsychotic mental disorder Exclusion

Data type

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

Data type

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

Data type

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

Data type

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

Data type

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
Back to the top of the page

Similar models

Eligibility Neuropathic Pain NCT00480181

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial