ID

15247

Description

A Study To Evaluate The Effect Of Topiramate On Clinical And Electrophysiological Parameters In Subjects With Diabetic Peripheral Polyneuropathy; ODM derived from: https://clinicaltrials.gov/show/NCT00231673

Link

https://clinicaltrials.gov/show/NCT00231673

Keywords

  1. 5/23/16 5/23/16 -
Uploaded on

May 23, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Diabetic Neuropathies NCT00231673

Eligibility Diabetic Neuropathies NCT00231673

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of type 2 diabetes mellitus
Description

diabetes mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0011860
pain for at least 6 months prior to randomization that the investigator attributes to diabetic peripheral polyneuropathy
Description

pain due to diabetic peripheral polyneuropathy

Data type

boolean

Alias
UMLS CUI [1,1]
C2673754
UMLS CUI [1,2]
C2673754
UMLS CUI [1,3]
C0011849
two sets of baseline nerve conduction studies and quantitative sensory testing
Description

nerve conduction studies and quantitative sensory testing

Data type

boolean

Alias
UMLS CUI [1]
C0200125
UMLS CUI [2]
C0430838
hba1c =< 9%
Description

HbA1c

Data type

boolean

Alias
UMLS CUI [1]
C0019018
diabetes controlled on stable regimen
Description

diabetes controlled

Data type

boolean

Alias
UMLS CUI [1]
C3274787
female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, practicing abstinence, or practicing an acceptable method of contraception (requires negative pregnancy test)
Description

postmenopausal or contraceptive use

Data type

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C1999124
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
diagnosis of type 1 diabetes mellitus
Description

diabetes mellitus type I

Data type

boolean

Alias
UMLS CUI [1]
C0011854
polyneuropathy due to other underlying causes
Description

polyneuropathy

Data type

boolean

Alias
UMLS CUI [1]
C0152025
hospitalization within the past 3 months due to episodes of hyper/hypoglycemia
Description

hospitalization due to episodes of hyper/hypoglycemia

Data type

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0020456
UMLS CUI [2,1]
C0019993
UMLS CUI [2,2]
C0020615
other unstable medical conditions
Description

other unstable medical conditions

Data type

boolean

Alias
UMLS CUI [1]
C3843040
history of suicidal attempts
Description

history of suicidal attempts

Data type

boolean

Alias
UMLS CUI [1]
C0038663
exposure to any other experimental drugs or device within the past 30 days
Description

exposure to any other experimental drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0013230

Similar models

Eligibility Diabetic Neuropathies NCT00231673

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
diabetes mellitus
Item
diagnosis of type 2 diabetes mellitus
boolean
C0011860 (UMLS CUI [1])
pain due to diabetic peripheral polyneuropathy
Item
pain for at least 6 months prior to randomization that the investigator attributes to diabetic peripheral polyneuropathy
boolean
C2673754 (UMLS CUI [1,1])
C2673754 (UMLS CUI [1,2])
C0011849 (UMLS CUI [1,3])
nerve conduction studies and quantitative sensory testing
Item
two sets of baseline nerve conduction studies and quantitative sensory testing
boolean
C0200125 (UMLS CUI [1])
C0430838 (UMLS CUI [2])
HbA1c
Item
hba1c =< 9%
boolean
C0019018 (UMLS CUI [1])
diabetes controlled
Item
diabetes controlled on stable regimen
boolean
C3274787 (UMLS CUI [1])
postmenopausal or contraceptive use
Item
female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, practicing abstinence, or practicing an acceptable method of contraception (requires negative pregnancy test)
boolean
C0232970 (UMLS CUI [1])
C1999124 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
diabetes mellitus type I
Item
diagnosis of type 1 diabetes mellitus
boolean
C0011854 (UMLS CUI [1])
polyneuropathy
Item
polyneuropathy due to other underlying causes
boolean
C0152025 (UMLS CUI [1])
hospitalization due to episodes of hyper/hypoglycemia
Item
hospitalization within the past 3 months due to episodes of hyper/hypoglycemia
boolean
C0019993 (UMLS CUI [1,1])
C0020456 (UMLS CUI [1,2])
C0019993 (UMLS CUI [2,1])
C0020615 (UMLS CUI [2,2])
other unstable medical conditions
Item
other unstable medical conditions
boolean
C3843040 (UMLS CUI [1])
history of suicidal attempts
Item
history of suicidal attempts
boolean
C0038663 (UMLS CUI [1])
exposure to any other experimental drugs
Item
exposure to any other experimental drugs or device within the past 30 days
boolean
C2348568 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])

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