ID

31409

Beskrivning

Safety/Efficacy of Tigan® to Control Nausea/Vomiting Experienced During Apokyn® Initiation and Treatment; ODM derived from: https://clinicaltrials.gov/show/NCT00489255

Länk

https://clinicaltrials.gov/show/NCT00489255

Nyckelord

Versioner (1)
  1. 2018-08-20 2018-08-20 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

20 augusti 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Parkinson's Disease NCT00489255

Engelsk

Eligibility Parkinson's Disease NCT00489255

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects aged 18 years or over
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
subjects with advanced parkinson's disease with disabling hypomobility ("off" episodes) who are to be initiated with apokyn® by intermittent subcutaneous injection
Beskrivning

Parkinson Disease Advanced | Hypomobility Disabling | Apokyn Subcutaneous Injections

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C0205179
UMLS CUI [2,1]
C0391852
UMLS CUI [2,2]
C4061999
UMLS CUI [3,1]
C1589388
UMLS CUI [3,2]
C0021499
able to swallow tigan®/placebo capsules
Beskrivning

Able to swallow Tigan | Able to swallow Placebo capsule

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0733768
UMLS CUI [2,1]
C2712086
UMLS CUI [2,2]
C1696465
UMLS CUI [2,3]
C0006935
subjects willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
Beskrivning

Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
women of child bearing potential must have a negative serum pregnancy test (beta hcg) prior to receiving study drug and must be using an appropriate form of contraception
Beskrivning

Childbearing Potential Pregnancy test negative beta hcg serum | Childbearing Potential Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
UMLS CUI [1,3]
C0741474
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
willing and able to provide informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
hypersensitive to apomorphine hydrochloride or any of the ingredients of apokyn®
Beskrivning

Hypersensitivity Apomorphine hydrochloride | Hypersensitivity Apokyn Ingredient

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0237406
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1589388
UMLS CUI [2,3]
C1550600
(notably sodium metabisulfite)
Beskrivning

sodium metabisulfite

Datatyp

boolean

Alias
UMLS CUI [1]
C0074744
hypersensitive to trimethobenzamide or any of the ingredients of tigan®
Beskrivning

Hypersensitivity Trimethobenzamide | Hypersensitivity Tigan Ingredient

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0077163
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0733768
UMLS CUI [2,3]
C1550600
previous treatment with apokyn®
Beskrivning

Apokyn

Datatyp

boolean

Alias
UMLS CUI [1]
C1589388
participation in any other clinical trial within 14 days of the present trial
Beskrivning

Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
contraindications to apokyn® or tigan®
Beskrivning

Medical contraindication Apokyn | Medical contraindication Tigan

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C1589388
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0733768
currently taking, or likely to need to take at any time during the course of the study, any 5ht3 antagonist (ondansetron, alosetron, granisetron, palonosetron or dolasetron)
Beskrivning

5HT3 Receptor Antagonists | Patient need for Probably 5HT3 Receptor Antagonists | Ondansetron | Alosetron | Granisetron | Palonosetron | Dolasetron

Datatyp

boolean

Alias
UMLS CUI [1]
C2917245
UMLS CUI [2,1]
C0686904
UMLS CUI [2,2]
C0750492
UMLS CUI [2,3]
C2917245
UMLS CUI [3]
C0061851
UMLS CUI [4]
C0291772
UMLS CUI [5]
C0061863
UMLS CUI [6]
C0220578
UMLS CUI [7]
C0209210
malignant melanoma or a history of previously treated malignant melanoma
Beskrivning

Melanoma | Melanoma Treated

Datatyp

boolean

Alias
UMLS CUI [1]
C0025202
UMLS CUI [2,1]
C0025202
UMLS CUI [2,2]
C1522326
pregnancy or breast feeding
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
receipt of any investigational (i.e. unapproved) medication within 30 days of starting the present trial
Beskrivning

Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
any significant medical disorder, condition, concomitant medication or psychiatric disorder according to dsm-iv criteria which would, in the opinion of the investigator, represent a hazard to the subject or prevent the subject from completing the trial
Beskrivning

Disease Study Subject Participation Status Hazard | Medical condition Study Subject Participation Status Hazard | Pharmaceutical Preparations Study Subject Participation Status Hazard | Mental disorders Study Subject Participation Status Hazard | Disease Preventing Completion of clinical trial | Medical condition Preventing Completion of clinical trial | Pharmaceutical Preparations Preventing Completion of clinical trial | Mental disorders Preventing Completion of clinical trial

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0598697
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C0598697
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C2348568
UMLS CUI [3,3]
C0598697
UMLS CUI [4,1]
C0004936
UMLS CUI [4,2]
C2348568
UMLS CUI [4,3]
C0598697
UMLS CUI [5,1]
C0012634
UMLS CUI [5,2]
C1292733
UMLS CUI [5,3]
C2732579
UMLS CUI [6,1]
C3843040
UMLS CUI [6,2]
C1292733
UMLS CUI [6,3]
C2732579
UMLS CUI [7,1]
C0013227
UMLS CUI [7,2]
C1292733
UMLS CUI [7,3]
C2732579
UMLS CUI [8,1]
C0004936
UMLS CUI [8,2]
C1292733
UMLS CUI [8,3]
C2732579
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Similar models

Eligibility Parkinson's Disease NCT00489255

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
subjects aged 18 years or over
boolean
C0001779 (UMLS CUI [1])
Parkinson Disease Advanced | Hypomobility Disabling | Apokyn Subcutaneous Injections
Item
subjects with advanced parkinson's disease with disabling hypomobility ("off" episodes) who are to be initiated with apokyn® by intermittent subcutaneous injection
boolean
C0030567 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0391852 (UMLS CUI [2,1])
C4061999 (UMLS CUI [2,2])
C1589388 (UMLS CUI [3,1])
C0021499 (UMLS CUI [3,2])
Able to swallow Tigan | Able to swallow Placebo capsule
Item
able to swallow tigan®/placebo capsules
boolean
C2712086 (UMLS CUI [1,1])
C0733768 (UMLS CUI [1,2])
C2712086 (UMLS CUI [2,1])
C1696465 (UMLS CUI [2,2])
C0006935 (UMLS CUI [2,3])
Protocol Compliance
Item
subjects willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
boolean
C0525058 (UMLS CUI [1])
Childbearing Potential Pregnancy test negative beta hcg serum | Childbearing Potential Contraceptive methods
Item
women of child bearing potential must have a negative serum pregnancy test (beta hcg) prior to receiving study drug and must be using an appropriate form of contraception
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C0741474 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Informed Consent
Item
willing and able to provide informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Apomorphine hydrochloride | Hypersensitivity Apokyn Ingredient
Item
hypersensitive to apomorphine hydrochloride or any of the ingredients of apokyn®
boolean
C0020517 (UMLS CUI [1,1])
C0237406 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1589388 (UMLS CUI [2,2])
C1550600 (UMLS CUI [2,3])
sodium metabisulfite
Item
(notably sodium metabisulfite)
boolean
C0074744 (UMLS CUI [1])
Hypersensitivity Trimethobenzamide | Hypersensitivity Tigan Ingredient
Item
hypersensitive to trimethobenzamide or any of the ingredients of tigan®
boolean
C0020517 (UMLS CUI [1,1])
C0077163 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0733768 (UMLS CUI [2,2])
C1550600 (UMLS CUI [2,3])
Apokyn
Item
previous treatment with apokyn®
boolean
C1589388 (UMLS CUI [1])
Study Subject Participation Status
Item
participation in any other clinical trial within 14 days of the present trial
boolean
C2348568 (UMLS CUI [1])
Medical contraindication Apokyn | Medical contraindication Tigan
Item
contraindications to apokyn® or tigan®
boolean
C1301624 (UMLS CUI [1,1])
C1589388 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0733768 (UMLS CUI [2,2])
5HT3 Receptor Antagonists | Patient need for Probably 5HT3 Receptor Antagonists | Ondansetron | Alosetron | Granisetron | Palonosetron | Dolasetron
Item
currently taking, or likely to need to take at any time during the course of the study, any 5ht3 antagonist (ondansetron, alosetron, granisetron, palonosetron or dolasetron)
boolean
C2917245 (UMLS CUI [1])
C0686904 (UMLS CUI [2,1])
C0750492 (UMLS CUI [2,2])
C2917245 (UMLS CUI [2,3])
C0061851 (UMLS CUI [3])
C0291772 (UMLS CUI [4])
C0061863 (UMLS CUI [5])
C0220578 (UMLS CUI [6])
C0209210 (UMLS CUI [7])
Melanoma | Melanoma Treated
Item
malignant melanoma or a history of previously treated malignant melanoma
boolean
C0025202 (UMLS CUI [1])
C0025202 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
pregnancy or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Investigational New Drugs
Item
receipt of any investigational (i.e. unapproved) medication within 30 days of starting the present trial
boolean
C0013230 (UMLS CUI [1])
Disease Study Subject Participation Status Hazard | Medical condition Study Subject Participation Status Hazard | Pharmaceutical Preparations Study Subject Participation Status Hazard | Mental disorders Study Subject Participation Status Hazard | Disease Preventing Completion of clinical trial | Medical condition Preventing Completion of clinical trial | Pharmaceutical Preparations Preventing Completion of clinical trial | Mental disorders Preventing Completion of clinical trial
Item
any significant medical disorder, condition, concomitant medication or psychiatric disorder according to dsm-iv criteria which would, in the opinion of the investigator, represent a hazard to the subject or prevent the subject from completing the trial
boolean
C0012634 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0598697 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C0598697 (UMLS CUI [2,3])
C0013227 (UMLS CUI [3,1])
C2348568 (UMLS CUI [3,2])
C0598697 (UMLS CUI [3,3])
C0004936 (UMLS CUI [4,1])
C2348568 (UMLS CUI [4,2])
C0598697 (UMLS CUI [4,3])
C0012634 (UMLS CUI [5,1])
C1292733 (UMLS CUI [5,2])
C2732579 (UMLS CUI [5,3])
C3843040 (UMLS CUI [6,1])
C1292733 (UMLS CUI [6,2])
C2732579 (UMLS CUI [6,3])
C0013227 (UMLS CUI [7,1])
C1292733 (UMLS CUI [7,2])
C2732579 (UMLS CUI [7,3])
C0004936 (UMLS CUI [8,1])
C1292733 (UMLS CUI [8,2])
C2732579 (UMLS CUI [8,3])
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