ID

22063

Descrição

Neuropathic Pain Assessment Comparing Pregabalin and Paroxetine in Management of MS-induced Neuropathic Pain; ODM derived from: https://clinicaltrials.gov/show/NCT00291148

Link

https://clinicaltrials.gov/show/NCT00291148

Palavras-chave

Versões (1)
  1. 17/05/2017 17/05/2017 -
Transferido a

17 de maio de 2017

DOI

Para um pedido faça login.

Licença

Creative Commons BY 4.0
Comentários do modelo :

Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.

Voltar para os comentários do modelo
Comentários do grupo de itens para :

Comentários do item para :

Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.

Eligibility Neuropathic Pain NCT00291148

Inglês

Eligibility Neuropathic Pain NCT00291148

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
• patients presenting with symptoms of neuropathic pain as determined by clinician, with a minimum vas pain score of 40mm as determined by a baseline score (0mm = no pain, 100mm = worst pain).
Descrição

Neuropathic pain Symptoms Visual analog scale pain score

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3714625
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C2732809
male and female patients between the ages of 18 and 65 years old.
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
clinically definite multiple sclerosis as defined by clinical history review, neurological examination and positive mri.
Descrição

Multiple Sclerosis Neurologic Examination | Multiple Sclerosis Magnetic Resonance Imaging Positive

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0026769
UMLS CUI [1,2]
C0027853
UMLS CUI [2,1]
C0026769
UMLS CUI [2,2]
C0024485
UMLS CUI [2,3]
C1514241
edss scores of < 6.0.
Descrição

Kurtzke multiple sclerosis rating scale

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0451246
no known hypersensitivity to the study medications.
Descrição

Hypersensitivity Absent Investigational New Drugs

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0013230
negative serum pregnancy test for all female patients of childbearing age; not currently breastfeeding.
Descrição

Childbearing Potential Serum pregnancy test negative | Breast Feeding Absent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C0332197
not currently treated with pregabalin, gabapentin, paroxetine or another ssri.
Descrição

Pregabalin Absent | Gabapentin Absent | Paroxetine Absent | Selective Serotonin Reuptake Inhibitors Absent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0657912
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0060926
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0070122
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0360105
UMLS CUI [4,2]
C0332197
no previous treatment failures with pregabalin or paroxetine.
Descrição

Pregabalin Unresponsive to Treatment Absent | Paroxetine Unresponsive to Treatment Absent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0657912
UMLS CUI [1,2]
C0205269
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0070122
UMLS CUI [2,2]
C0205269
UMLS CUI [2,3]
C0332197
baseline creatinine clearance (clcr) of > 50ml/min.
Descrição

Creatinine clearance measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0373595
no significant hepatic insufficiency.
Descrição

Hepatic Insufficiency Absent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1306571
UMLS CUI [1,2]
C0332197
if on other pain medications, must be on stable dose for at least 6 months and other medications must not elicit significant drug-drug interactions with study medications.
Descrição

Analgesics Dose Stable | Pharmaceutical Preparations | Investigational New Drugs | Drug Interactions Absent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0002771
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2]
C0013227
UMLS CUI [3]
C0013230
UMLS CUI [4,1]
C0687133
UMLS CUI [4,2]
C0332197
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
Voltar ao início da página

Similar models

Eligibility Neuropathic Pain NCT00291148

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Neuropathic pain Symptoms Visual analog scale pain score
Item
• patients presenting with symptoms of neuropathic pain as determined by clinician, with a minimum vas pain score of 40mm as determined by a baseline score (0mm = no pain, 100mm = worst pain).
boolean
C3714625 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C2732809 (UMLS CUI [1,3])
Age
Item
male and female patients between the ages of 18 and 65 years old.
boolean
C0001779 (UMLS CUI [1])
Multiple Sclerosis Neurologic Examination | Multiple Sclerosis Magnetic Resonance Imaging Positive
Item
clinically definite multiple sclerosis as defined by clinical history review, neurological examination and positive mri.
boolean
C0026769 (UMLS CUI [1,1])
C0027853 (UMLS CUI [1,2])
C0026769 (UMLS CUI [2,1])
C0024485 (UMLS CUI [2,2])
C1514241 (UMLS CUI [2,3])
Kurtzke multiple sclerosis rating scale
Item
edss scores of < 6.0.
boolean
C0451246 (UMLS CUI [1])
Hypersensitivity Absent Investigational New Drugs
Item
no known hypersensitivity to the study medications.
boolean
C0020517 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
Childbearing Potential Serum pregnancy test negative | Breast Feeding Absent
Item
negative serum pregnancy test for all female patients 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])
Pregabalin Absent | Gabapentin Absent | Paroxetine Absent | Selective Serotonin Reuptake Inhibitors Absent
Item
not currently treated with pregabalin, gabapentin, paroxetine or another ssri.
boolean
C0657912 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0060926 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0070122 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0360105 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Pregabalin Unresponsive to Treatment Absent | Paroxetine Unresponsive to Treatment Absent
Item
no previous treatment failures with pregabalin or paroxetine.
boolean
C0657912 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0070122 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Creatinine clearance measurement
Item
baseline creatinine clearance (clcr) of > 50ml/min.
boolean
C0373595 (UMLS CUI [1])
Hepatic Insufficiency Absent
Item
no significant hepatic insufficiency.
boolean
C1306571 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Analgesics Dose Stable | Pharmaceutical Preparations | Investigational New Drugs | Drug Interactions Absent
Item
if on other pain medications, must be on stable dose for at least 6 months and other medications must not elicit significant drug-drug interactions with study medications.
boolean
C0002771 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
C0687133 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
Voltar ao início da página 

Contacto

Use este formulário para feedback, perguntas e sugestões de aperfeiçoamento.

Campos marcados com * são obrigatórios.

Ajuda

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