ID

31450

Beskrivning

A Study to Compare Pharmacokinetics and Pharmacodynamics of IPX066 to Standard Carbidopa-Levodopa; ODM derived from: https://clinicaltrials.gov/show/NCT00869791

Länk

https://clinicaltrials.gov/show/NCT00869791

Nyckelord

Versioner (1)
  1. 2018-08-23 2018-08-23 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

23 augusti 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Parkinson's Disease NCT00869791

Engelsk

Eligibility Parkinson's Disease NCT00869791

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male or female diagnosed with idiopathic pd, without any known cause for parkinsonism.
Beskrivning

Parkinson Disease | Parkinsonism Etiology unknown

Datatyp

boolean

Alias
UMLS CUI [1]
C0030567
UMLS CUI [2,1]
C0242422
UMLS CUI [2,2]
C0743626
2. if female and of childbearing potential, subject should be abstinent or continuing to practice and willing to continue throughout the study with appropriate contraceptives (defined as nova ring, oral, injected, transdermal patch, implanted, or barrier). the subject must agree to take every precaution to ensure that pregnancy will not occur during the study.
Beskrivning

Childbearing Potential Sexual Abstinence | Childbearing Potential Contraceptive methods | NuvaRing Vaginal Product | Oral contraception | Injectable contraception | Ttransdermal patch | Contraceptive implant | Contraception, Barrier

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0036899
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [3]
C3233268
UMLS CUI [4]
C0029151
UMLS CUI [5]
C1262153
UMLS CUI [6]
C2135981
UMLS CUI [7]
C1657106
UMLS CUI [8]
C0004764
3. at least 30 years old at the time of diagnosis of pd.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
4. mini mental state examination (mmse) ≥ 26 at screening visit.
Beskrivning

Mini-mental state examination

Datatyp

boolean

Alias
UMLS CUI [1]
C0451306
5. a responder to ld and currently being chronically treated with stable dosage of commercially available standard, orally disintegrating, or controlled-release cd ld for at least 1 month.
Beskrivning

Levodopa-responsive | Carbidopa / Levodopa Dose Stable | Carbidopa / Levodopa Oral Product | Carbidopa / Levodopa Controlled release

Datatyp

boolean

Alias
UMLS CUI [1]
C1853846
UMLS CUI [2,1]
C0353697
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
UMLS CUI [3]
C3210219
UMLS CUI [4,1]
C0353697
UMLS CUI [4,2]
C0868939
6. must have predictable fluctuations between "on" and "off" states.
Beskrivning

Fluctuation On - off phenomenon

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0231239
UMLS CUI [1,2]
C0852903
7. hoehn and yahr stage i-iv when "on".
Beskrivning

Hoehn and Yahr Stage

Datatyp

boolean

Alias
UMLS CUI [1]
C3639483
8. able to provide informed consent and willing to sign health insurance portability and accountability act (hipaa) authorization.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
9. able and willing to comply with the protocol, including availability for all scheduled study visits and blood sample collections.
Beskrivning

Protocol Compliance | Availability of Blood specimen

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2,1]
C0470187
UMLS CUI [2,2]
C0178913
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. pregnant or breastfeeding.
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
2. diagnosed with atypical parkinsonism.
Beskrivning

Atypical Parkinsonism

Datatyp

boolean

Alias
UMLS CUI [1]
C4302185
3. history, physical findings or laboratory results suggesting a diagnosis other than pd.
Beskrivning

Medical History Suggestive of Diagnosis Other | Physical findings Suggestive of Diagnosis Other | Laboratory Results Suggestive of Diagnosis Other | Exception Parkinson Disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0332299
UMLS CUI [1,3]
C0011900
UMLS CUI [1,4]
C0205394
UMLS CUI [2,1]
C0311392
UMLS CUI [2,2]
C0332299
UMLS CUI [2,3]
C0011900
UMLS CUI [2,4]
C0205394
UMLS CUI [3,1]
C1254595
UMLS CUI [3,2]
C0332299
UMLS CUI [3,3]
C0011900
UMLS CUI [3,4]
C0205394
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0030567
4. allergic or nonresponsive to previous cd-ld therapy.
Beskrivning

Hypersensitivity Carbidopa / Levodopa | Unresponsive to Carbidopa / Levodopa

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0353697
UMLS CUI [2,1]
C0205269
UMLS CUI [2,2]
C0353697
5. any medical (e.g., liver or kidney impairment, peptic ulcer) or condition/history that, in the investigator's opinion, may jeopardize the subject's safety.
Beskrivning

Medical condition compromises Patient safety | Hepatic impairment | Renal Insufficiency | Peptic Ulcer

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C1113679
UMLS CUI [2]
C0948807
UMLS CUI [3]
C1565489
UMLS CUI [4]
C0030920
6. exposure to any investigational agent within 30 days prior to visit 1.
Beskrivning

Exposure to Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0013230
7. donated blood or plasma within 28 days.
Beskrivning

Blood Donation | Plasma Donation

Datatyp

boolean

Alias
UMLS CUI [1]
C0005794
UMLS CUI [2,1]
C0032105
UMLS CUI [2,2]
C0680854
20. had prior functional neurosurgical treatment for pd (ablation or deep brain stimulation).
Beskrivning

Neurosurgical Procedures Functional Parkinson Disease | Ablation | Deep Brain Stimulation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0524850
UMLS CUI [1,2]
C0205245
UMLS CUI [1,3]
C0030567
UMLS CUI [2]
C0547070
UMLS CUI [3]
C0394162
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Similar models

Eligibility Parkinson's Disease NCT00869791

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Parkinson Disease | Parkinsonism Etiology unknown
Item
1. male or female diagnosed with idiopathic pd, without any known cause for parkinsonism.
boolean
C0030567 (UMLS CUI [1])
C0242422 (UMLS CUI [2,1])
C0743626 (UMLS CUI [2,2])
Childbearing Potential Sexual Abstinence | Childbearing Potential Contraceptive methods | NuvaRing Vaginal Product | Oral contraception | Injectable contraception | Ttransdermal patch | Contraceptive implant | Contraception, Barrier
Item
2. if female and of childbearing potential, subject should be abstinent or continuing to practice and willing to continue throughout the study with appropriate contraceptives (defined as nova ring, oral, injected, transdermal patch, implanted, or barrier). the subject must agree to take every precaution to ensure that pregnancy will not occur during the study.
boolean
C3831118 (UMLS CUI [1,1])
C0036899 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C3233268 (UMLS CUI [3])
C0029151 (UMLS CUI [4])
C1262153 (UMLS CUI [5])
C2135981 (UMLS CUI [6])
C1657106 (UMLS CUI [7])
C0004764 (UMLS CUI [8])
Age
Item
3. at least 30 years old at the time of diagnosis of pd.
boolean
C0001779 (UMLS CUI [1])
Mini-mental state examination
Item
4. mini mental state examination (mmse) ≥ 26 at screening visit.
boolean
C0451306 (UMLS CUI [1])
Levodopa-responsive | Carbidopa / Levodopa Dose Stable | Carbidopa / Levodopa Oral Product | Carbidopa / Levodopa Controlled release
Item
5. a responder to ld and currently being chronically treated with stable dosage of commercially available standard, orally disintegrating, or controlled-release cd ld for at least 1 month.
boolean
C1853846 (UMLS CUI [1])
C0353697 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C3210219 (UMLS CUI [3])
C0353697 (UMLS CUI [4,1])
C0868939 (UMLS CUI [4,2])
Fluctuation On - off phenomenon
Item
6. must have predictable fluctuations between "on" and "off" states.
boolean
C0231239 (UMLS CUI [1,1])
C0852903 (UMLS CUI [1,2])
Hoehn and Yahr Stage
Item
7. hoehn and yahr stage i-iv when "on".
boolean
C3639483 (UMLS CUI [1])
Informed Consent
Item
8. able to provide informed consent and willing to sign health insurance portability and accountability act (hipaa) authorization.
boolean
C0021430 (UMLS CUI [1])
Protocol Compliance | Availability of Blood specimen
Item
9. able and willing to comply with the protocol, including availability for all scheduled study visits and blood sample collections.
boolean
C0525058 (UMLS CUI [1])
C0470187 (UMLS CUI [2,1])
C0178913 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
1. pregnant or breastfeeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Atypical Parkinsonism
Item
2. diagnosed with atypical parkinsonism.
boolean
C4302185 (UMLS CUI [1])
Medical History Suggestive of Diagnosis Other | Physical findings Suggestive of Diagnosis Other | Laboratory Results Suggestive of Diagnosis Other | Exception Parkinson Disease
Item
3. history, physical findings or laboratory results suggesting a diagnosis other than pd.
boolean
C0262926 (UMLS CUI [1,1])
C0332299 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C0311392 (UMLS CUI [2,1])
C0332299 (UMLS CUI [2,2])
C0011900 (UMLS CUI [2,3])
C0205394 (UMLS CUI [2,4])
C1254595 (UMLS CUI [3,1])
C0332299 (UMLS CUI [3,2])
C0011900 (UMLS CUI [3,3])
C0205394 (UMLS CUI [3,4])
C1705847 (UMLS CUI [4,1])
C0030567 (UMLS CUI [4,2])
Hypersensitivity Carbidopa / Levodopa | Unresponsive to Carbidopa / Levodopa
Item
4. allergic or nonresponsive to previous cd-ld therapy.
boolean
C0020517 (UMLS CUI [1,1])
C0353697 (UMLS CUI [1,2])
C0205269 (UMLS CUI [2,1])
C0353697 (UMLS CUI [2,2])
Medical condition compromises Patient safety | Hepatic impairment | Renal Insufficiency | Peptic Ulcer
Item
5. any medical (e.g., liver or kidney impairment, peptic ulcer) or condition/history that, in the investigator's opinion, may jeopardize the subject's safety.
boolean
C3843040 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0948807 (UMLS CUI [2])
C1565489 (UMLS CUI [3])
C0030920 (UMLS CUI [4])
Exposure to Investigational New Drugs
Item
6. exposure to any investigational agent within 30 days prior to visit 1.
boolean
C0332157 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Blood Donation | Plasma Donation
Item
7. donated blood or plasma within 28 days.
boolean
C0005794 (UMLS CUI [1])
C0032105 (UMLS CUI [2,1])
C0680854 (UMLS CUI [2,2])
Neurosurgical Procedures Functional Parkinson Disease | Ablation | Deep Brain Stimulation
Item
20. had prior functional neurosurgical treatment for pd (ablation or deep brain stimulation).
boolean
C0524850 (UMLS CUI [1,1])
C0205245 (UMLS CUI [1,2])
C0030567 (UMLS CUI [1,3])
C0547070 (UMLS CUI [2])
C0394162 (UMLS CUI [3])
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