ID

21149

Description

Comparison of IPX054, Immediate-Release Carbidopa-Levodopa, and Controlled-Release Carbidopa-Levodopa in Subjects With Parkinson's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00279825

Link

https://clinicaltrials.gov/show/NCT00279825

Keywords

  1. 4/11/17 4/11/17 -
Uploaded on

April 11, 2017

DOI

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License

Creative Commons BY 4.0

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Eligibility Idiopathic Parkinson's Disease NCT00279825

Eligibility Idiopathic Parkinson's Disease NCT00279825

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosed with idiopathic parkinson's disease.
Description

Parkinson Disease

Data type

boolean

Alias
UMLS CUI [1]
C0030567
currently being treated with immediate-release or controlled-release carbidopa-levodopa and not requiring more than 200 mg levodopa per dose.
Description

Carbidopa / Levodopa Immediate Release | Carbidopa / Levodopa Controlled Release | Levodopa Dose

Data type

boolean

Alias
UMLS CUI [1,1]
C0353697
UMLS CUI [1,2]
C1708470
UMLS CUI [2,1]
C0353697
UMLS CUI [2,2]
C1707506
UMLS CUI [3,1]
C0023570
UMLS CUI [3,2]
C0178602
must experience "wearing off" between doses of medication.
Description

Wearing off effect Pharmaceutical Preparations Dosage

Data type

boolean

Alias
UMLS CUI [1,1]
C1504539
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0178602
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
diagnosed with atypical parkinsonism.
Description

Atypical Parkinson Disease

Data type

boolean

Alias
UMLS CUI [1]
C1868596
allergic or non-responsive to previous carbidopa-levodopa therapy.
Description

Carbidopa + levodopa allergy | Carbidopa / Levodopa Absent response to treatment

Data type

boolean

Alias
UMLS CUI [1]
C0570732
UMLS CUI [2,1]
C0353697
UMLS CUI [2,2]
C0438286
active or history of narrow-angle or wide-angle glaucoma.
Description

Angle Closure Glaucoma | Glaucoma, Open-Angle

Data type

boolean

Alias
UMLS CUI [1]
C0017605
UMLS CUI [2]
C0017612
history of seizure or epilepsy, or is currently taking an anti-convulsant for treatment of seizures.
Description

Seizures | Epilepsy | Anticonvulsants

Data type

boolean

Alias
UMLS CUI [1]
C0036572
UMLS CUI [2]
C0014544
UMLS CUI [3]
C0003286
treatment with any neuroleptic agent, including atypical neuroleptics, within the previous 12 months.
Description

Antipsychotic Agents | Antipsychotic Agents Atypical

Data type

boolean

Alias
UMLS CUI [1]
C0040615
UMLS CUI [2,1]
C0040615
UMLS CUI [2,2]
C0205182
treatment with any dopaminergic blocking agent within the previous 3 months.
Description

Dopamine Antagonists

Data type

boolean

Alias
UMLS CUI [1]
C0242702

Similar models

Eligibility Idiopathic Parkinson's Disease NCT00279825

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Parkinson Disease
Item
diagnosed with idiopathic parkinson's disease.
boolean
C0030567 (UMLS CUI [1])
Carbidopa / Levodopa Immediate Release | Carbidopa / Levodopa Controlled Release | Levodopa Dose
Item
currently being treated with immediate-release or controlled-release carbidopa-levodopa and not requiring more than 200 mg levodopa per dose.
boolean
C0353697 (UMLS CUI [1,1])
C1708470 (UMLS CUI [1,2])
C0353697 (UMLS CUI [2,1])
C1707506 (UMLS CUI [2,2])
C0023570 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
Wearing off effect Pharmaceutical Preparations Dosage
Item
must experience "wearing off" between doses of medication.
boolean
C1504539 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Atypical Parkinson Disease
Item
diagnosed with atypical parkinsonism.
boolean
C1868596 (UMLS CUI [1])
Carbidopa + levodopa allergy | Carbidopa / Levodopa Absent response to treatment
Item
allergic or non-responsive to previous carbidopa-levodopa therapy.
boolean
C0570732 (UMLS CUI [1])
C0353697 (UMLS CUI [2,1])
C0438286 (UMLS CUI [2,2])
Angle Closure Glaucoma | Glaucoma, Open-Angle
Item
active or history of narrow-angle or wide-angle glaucoma.
boolean
C0017605 (UMLS CUI [1])
C0017612 (UMLS CUI [2])
Seizures | Epilepsy | Anticonvulsants
Item
history of seizure or epilepsy, or is currently taking an anti-convulsant for treatment of seizures.
boolean
C0036572 (UMLS CUI [1])
C0014544 (UMLS CUI [2])
C0003286 (UMLS CUI [3])
Antipsychotic Agents | Antipsychotic Agents Atypical
Item
treatment with any neuroleptic agent, including atypical neuroleptics, within the previous 12 months.
boolean
C0040615 (UMLS CUI [1])
C0040615 (UMLS CUI [2,1])
C0205182 (UMLS CUI [2,2])
Dopamine Antagonists
Item
treatment with any dopaminergic blocking agent within the previous 3 months.
boolean
C0242702 (UMLS CUI [1])

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