ID

34062

Description

A Study to Compare the Adhesiveness of 2 Different Rotigotine Patches Used for the Treatment of Parkinson's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT02230904

Link

https://clinicaltrials.gov/show/NCT02230904

Keywords

Versions (1)
  1. 1/13/19 1/13/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 13, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Parkinson's Disease NCT02230904

English

Eligibility Parkinson's Disease NCT02230904

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subject has a diagnosis of idiopathic parkinson's disease
Description

Parkinson Disease

Data type

boolean

Alias
UMLS CUI [1]
C0030567
subject has been on continuous treatment with commercially available rotigotine transdermal patches (neupro®) for at least 3 months prior to enrollment
Description

Rotigotine Transdermal patch | Neupro

Data type

boolean

Alias
UMLS CUI [1,1]
C1700683
UMLS CUI [1,2]
C0991556
UMLS CUI [2]
C1949346
subject has been taking a stable rotigotine dose including an 8 mg/24 hours (40 cm^2) patch for at least 2 weeks prior to enrollment
Description

Rotigotine Dose Stable | Rotigotine Transdermal patch

Data type

boolean

Alias
UMLS CUI [1,1]
C1700683
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C1700683
UMLS CUI [2,2]
C0991556
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject has any medical or psychiatric condition which, in the opinion of the investigator, could jeopardize or would compromise the subject's well-being or ability to participate in this study
Description

Medical condition compromises Study Subject Well Being | Mental condition compromises Study Subject Well Being | Medical condition compromises Study Subject Participation Status | Mental condition compromises Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C0681850
UMLS CUI [1,4]
C3813622
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C2945640
UMLS CUI [2,3]
C0681850
UMLS CUI [2,4]
C3813622
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C2945640
UMLS CUI [3,3]
C2348568
UMLS CUI [4,1]
C3840291
UMLS CUI [4,2]
C2945640
UMLS CUI [4,3]
C2348568
subject has a history of significant skin hypersensitivity to adhesives or other transdermal products or recently unsolved contact dermatitis
Description

Cutaneous hypersensitivity Adhesives | Cutaneous hypersensitivity Transdermal Product | Contact Dermatitis Resolution Lacking

Data type

boolean

Alias
UMLS CUI [1,1]
C0585186
UMLS CUI [1,2]
C0001516
UMLS CUI [2,1]
C0585186
UMLS CUI [2,2]
C3465388
UMLS CUI [3,1]
C0011616
UMLS CUI [3,2]
C1514893
UMLS CUI [3,3]
C0332268
subject has a history or present condition of an atopic or eczematous dermatitis, psoriasis, or an active skin disease
Description

Dermatitis, Atopic | Eczema | Psoriasis | Dermatologic disorders

Data type

boolean

Alias
UMLS CUI [1]
C0011615
UMLS CUI [2]
C0013595
UMLS CUI [3]
C0033860
UMLS CUI [4]
C0037274
subject has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response ("yes") to either question 4 or question 5 of the columbia-suicide severity rating scale (c-ssrs) at screening (visit 1) or baseline (visit 2)
Description

Suicide attempt Lifetime | Suicide attempt | Suicide attempt Interrupted | Suicide attempt aborted | Feeling suicidal C-SSRS Screening Questionnaire | Feeling suicidal C-SSRS Baseline Questionnaire

Data type

boolean

Alias
UMLS CUI [1,1]
C0038663
UMLS CUI [1,2]
C4071830
UMLS CUI [2]
C0038663
UMLS CUI [3,1]
C0038663
UMLS CUI [3,2]
C1512900
UMLS CUI [4,1]
C0038663
UMLS CUI [4,2]
C1609614
UMLS CUI [5,1]
C0424000
UMLS CUI [5,2]
C3827015
UMLS CUI [6,1]
C0424000
UMLS CUI [6,2]
C3639710
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Similar models

Eligibility Parkinson's Disease NCT02230904

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Parkinson Disease
Item
subject has a diagnosis of idiopathic parkinson's disease
boolean
C0030567 (UMLS CUI [1])
Rotigotine Transdermal patch | Neupro
Item
subject has been on continuous treatment with commercially available rotigotine transdermal patches (neupro®) for at least 3 months prior to enrollment
boolean
C1700683 (UMLS CUI [1,1])
C0991556 (UMLS CUI [1,2])
C1949346 (UMLS CUI [2])
Rotigotine Dose Stable | Rotigotine Transdermal patch
Item
subject has been taking a stable rotigotine dose including an 8 mg/24 hours (40 cm^2) patch for at least 2 weeks prior to enrollment
boolean
C1700683 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C1700683 (UMLS CUI [2,1])
C0991556 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Medical condition compromises Study Subject Well Being | Mental condition compromises Study Subject Well Being | Medical condition compromises Study Subject Participation Status | Mental condition compromises Study Subject Participation Status
Item
subject has any medical or psychiatric condition which, in the opinion of the investigator, could jeopardize or would compromise the subject's well-being or ability to participate in this study
boolean
C3843040 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C0681850 (UMLS CUI [1,3])
C3813622 (UMLS CUI [1,4])
C3840291 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C0681850 (UMLS CUI [2,3])
C3813622 (UMLS CUI [2,4])
C3843040 (UMLS CUI [3,1])
C2945640 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
C3840291 (UMLS CUI [4,1])
C2945640 (UMLS CUI [4,2])
C2348568 (UMLS CUI [4,3])
Cutaneous hypersensitivity Adhesives | Cutaneous hypersensitivity Transdermal Product | Contact Dermatitis Resolution Lacking
Item
subject has a history of significant skin hypersensitivity to adhesives or other transdermal products or recently unsolved contact dermatitis
boolean
C0585186 (UMLS CUI [1,1])
C0001516 (UMLS CUI [1,2])
C0585186 (UMLS CUI [2,1])
C3465388 (UMLS CUI [2,2])
C0011616 (UMLS CUI [3,1])
C1514893 (UMLS CUI [3,2])
C0332268 (UMLS CUI [3,3])
Dermatitis, Atopic | Eczema | Psoriasis | Dermatologic disorders
Item
subject has a history or present condition of an atopic or eczematous dermatitis, psoriasis, or an active skin disease
boolean
C0011615 (UMLS CUI [1])
C0013595 (UMLS CUI [2])
C0033860 (UMLS CUI [3])
C0037274 (UMLS CUI [4])
Suicide attempt Lifetime | Suicide attempt | Suicide attempt Interrupted | Suicide attempt aborted | Feeling suicidal C-SSRS Screening Questionnaire | Feeling suicidal C-SSRS Baseline Questionnaire
Item
subject has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response ("yes") to either question 4 or question 5 of the columbia-suicide severity rating scale (c-ssrs) at screening (visit 1) or baseline (visit 2)
boolean
C0038663 (UMLS CUI [1,1])
C4071830 (UMLS CUI [1,2])
C0038663 (UMLS CUI [2])
C0038663 (UMLS CUI [3,1])
C1512900 (UMLS CUI [3,2])
C0038663 (UMLS CUI [4,1])
C1609614 (UMLS CUI [4,2])
C0424000 (UMLS CUI [5,1])
C3827015 (UMLS CUI [5,2])
C0424000 (UMLS CUI [6,1])
C3639710 (UMLS CUI [6,2])
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