ID

22063

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00291148

Nyckelord

Versioner (1)
  1. 2017-05-17 2017-05-17 -
Uppladdad den

17 maj 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Neuropathic Pain NCT00291148

Engelsk

Eligibility Neuropathic Pain NCT00291148

1 Formulär  
Inclusion Criteria
Beskrivning

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).
Beskrivning

Neuropathic pain Symptoms Visual analog scale pain score

Datatyp

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.
Beskrivning

Age

Datatyp

boolean

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

Multiple Sclerosis Neurologic Examination | Multiple Sclerosis Magnetic Resonance Imaging Positive

Datatyp

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.
Beskrivning

Kurtzke multiple sclerosis rating scale

Datatyp

boolean

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

Hypersensitivity Absent Investigational New Drugs

Datatyp

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.
Beskrivning

Childbearing Potential Serum pregnancy test negative | Breast Feeding Absent

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

Pregabalin Unresponsive to Treatment Absent | Paroxetine Unresponsive to Treatment Absent

Datatyp

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.
Beskrivning

Creatinine clearance measurement

Datatyp

boolean

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

Hepatic Insufficiency Absent

Datatyp

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.
Beskrivning

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

Datatyp

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
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
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Similar models

Eligibility Neuropathic Pain NCT00291148

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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)
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