ID

36813

Beskrivning

A Single Period Investigation to Assess the Tolerability of Healthy Subjects to Oral Sinemet® (Levodopa/Carbidopa); ODM derived from: https://clinicaltrials.gov/show/NCT02486432

Länk

https://clinicaltrials.gov/show/NCT02486432

Nyckelord

Versioner (1)
  1. 2019-06-12 2019-06-12 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

12 juni 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Parkinson's Disease NCT02486432

Engelsk

Eligibility Parkinson's Disease NCT02486432

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. healthy males or non-pregnant, non-lactating healthy females
Beskrivning

Gender Healthy | Pregnancy Absent | Breast Feeding Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C3898900
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0006147
UMLS CUI [3,2]
C0332197
2. age 40 to 65 years of age
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
3. body mass index of 18.0 to 35.0 kg/m2 or, if outside the range, considered not clinically significant by the investigator
Beskrivning

Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
4. must be willing and able to communicate and participate in the whole study
Beskrivning

Communication Willing | Able to communicate | Participation Clinical Trial Willing | Participation Clinical Trial Able

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009452
UMLS CUI [1,2]
C0600109
UMLS CUI [2]
C2364293
UMLS CUI [3,1]
C0679823
UMLS CUI [3,2]
C0008976
UMLS CUI [3,3]
C0600109
UMLS CUI [4,1]
C0679823
UMLS CUI [4,2]
C0008976
UMLS CUI [4,3]
C0085732
5. must provide written informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
6. must agree to use an adequate method of contraception
Beskrivning

Use of Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. participation in a clinical research study within the previous 3 months
Beskrivning

Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
2. subjects who are study site employees, or immediate family members of a study site or sponsor employee
Beskrivning

Employee Study Site | Family member Study Site | Employee Sponsor

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0599987
UMLS CUI [1,2]
C2347790
UMLS CUI [2,1]
C0086282
UMLS CUI [2,2]
C2347790
UMLS CUI [3,1]
C0599987
UMLS CUI [3,2]
C2347796
3. subjects who have previously been enrolled in this study
Beskrivning

Study Subject Participation Status | Enrollment Previous

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C1516879
UMLS CUI [2,2]
C0205156
4. history of any drug or alcohol abuse in the past 2 years
Beskrivning

Substance Use Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
5. regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = ½ pint beer, 25 ml of 40% spirit or a 125 ml glass of wine)
Beskrivning

Alcohol consumption Regular | Alcohol units/week Beer | Alcohol units/week Spirit | Alcohol units/week Wine | Gender

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0205272
UMLS CUI [2,1]
C0560579
UMLS CUI [2,2]
C0004922
UMLS CUI [3,1]
C0560579
UMLS CUI [3,2]
C0301611
UMLS CUI [4,1]
C0560579
UMLS CUI [4,2]
C0043188
UMLS CUI [5]
C0079399
6. current smokers and those who have smoked within the last 12 months. a breath carbon monoxide reading of greater than 10 ppm at screening
Beskrivning

Tobacco use | Breath test expired carbon monoxide

Datatyp

boolean

Alias
UMLS CUI [1]
C0543414
UMLS CUI [2]
C2207180
7. females of childbearing potential who are pregnant or lactating (female subjects must have a negative urine pregnancy test at admission)
Beskrivning

Pregnancy | Breast Feeding | Childbearing Potential Urine pregnancy test negative

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0430057
8. clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator (laboratory parameters are listed in appendix 1)
Beskrivning

Abnormal biochemistry finding | Hematology finding abnormal | Urine screening abnormal

Datatyp

boolean

Alias
UMLS CUI [1]
C0586680
UMLS CUI [2]
C0475182
UMLS CUI [3]
C0438142
9. positive drugs of abuse test result (drugs of abuse tests are listed in appendix 1)
Beskrivning

Drug abuse screening test Positive

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0451130
UMLS CUI [1,2]
C1514241
10. positive hepatitis b surface antigen (hbsag), hepatitis c virus antibody (hcv ab) or human immunodeficiency virus (hiv) results
Beskrivning

Hepatitis B surface antigen positive | Hepatitis C antibody positive | HIV Seropositivity

Datatyp

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2]
C0281863
UMLS CUI [3]
C0019699
11. history of cardiovascular, renal, hepatic, chronic respiratory or gi disease as judged by the investigator
Beskrivning

Cardiovascular Disease | Kidney Disease | Liver disease | Chronic disease of respiratory system | Gastrointestinal Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0022658
UMLS CUI [3]
C0023895
UMLS CUI [4]
C0264220
UMLS CUI [5]
C0017178
12. serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
Beskrivning

Adverse reaction Serious Pharmaceutical Preparations | Hypersensitivity Serious Pharmaceutical Preparations | Adverse reaction Serious Pharmaceutical Excipient | Hypersensitivity Serious Pharmaceutical Excipient

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0559546
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0013227
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C0013227
UMLS CUI [3,1]
C0559546
UMLS CUI [3,2]
C0205404
UMLS CUI [3,3]
C0015237
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0205404
UMLS CUI [4,3]
C0015237
13. presence or history of clinically significant allergy requiring treatment, as judged by the investigator. hayfever is allowed unless it is active
Beskrivning

Hypersensitivity Treatment required for

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0332121
14. donation or loss of greater than 400 ml of blood within the previous 3 months
Beskrivning

Blood Donation Amount | Blood Loss Amount

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005794
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C3163616
UMLS CUI [2,2]
C1265611
15. subjects who are taking, or have taken, any prescribed or over-the-counter drug (other than 4 g per day paracetamol, hormone replacement therapy and hormonal contraception) or herbal remedies in the 14 days before imp administration (see section 11.4)
Beskrivning

Prescription of drug | Drugs, Non-Prescription | Exception Acetaminophen U/day | Exception Hormone replacement therapy | Exception Hormonal contraception | Herbal medicine

Datatyp

boolean

Alias
UMLS CUI [1]
C2239117
UMLS CUI [2]
C0013231
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0000970
UMLS CUI [3,3]
C0456683
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0282402
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C2985296
UMLS CUI [6]
C2240391
16. use of any non-selective monoamine oxidase (mao) inhibitors within 2 weeks of screening
Beskrivning

Monoamine oxidase inhibitors, non-selective

Datatyp

boolean

Alias
UMLS CUI [1]
C3653330
17. history or presence of glaucoma
Beskrivning

Glaucoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0017601
18. history or presence of suspicious undiagnosed skin lesions or a history of melanoma
Beskrivning

Skin lesion Suspicious | Melanoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0037284
UMLS CUI [1,2]
C0750493
UMLS CUI [2]
C0025202
19. any history of psychoses or seizure
Beskrivning

Psychotic Disorders | Seizure

Datatyp

boolean

Alias
UMLS CUI [1]
C0033975
UMLS CUI [2]
C0036572
20. known hypersensitivity to sinemet® or domperidone or any of the excipients
Beskrivning

Hypersensitivity Sinemet | Domperidone allergy | Hypersensitivity Sinemet Excipient | Hypersensitivity Domperidone Excipient

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0074559
UMLS CUI [2]
C0570598
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0074559
UMLS CUI [3,3]
C0015237
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0013015
UMLS CUI [4,3]
C0015237
21. any history or presence of prolactin-releasing pituitary tumour (prolactinoma)
Beskrivning

Prolactinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0033375
22. any medical history of gi haemorrhage, mechanical obstruction or perforation
Beskrivning

Gastrointestinal Hemorrhage | Gastrointestinal obstruction | Gastrointestinal perforation

Datatyp

boolean

Alias
UMLS CUI [1]
C0017181
UMLS CUI [2]
C0236124
UMLS CUI [3]
C0151664
23. any history of moderate or severe hepatic impairment
Beskrivning

Hepatic impairment Moderate | Hepatic impairment Severe

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0948807
UMLS CUI [1,2]
C0205081
UMLS CUI [2,1]
C0948807
UMLS CUI [2,2]
C0205082
24. subjects with clinically significant liver function tests
Beskrivning

Liver Function Tests Clinical Significance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023901
UMLS CUI [1,2]
C2826293
25. subjects with qtc > 450 ms at screening sponsor/quotient clinical confidential protocol nd0612-013 (qcl117546) version 1.0 02 feb 2015 page 23 of 42
Beskrivning

Prolonged QTc

Datatyp

boolean

Alias
UMLS CUI [1]
C1969409
26. subjects with significant electrolyte disturbances
Beskrivning

Electrolyte imbalance

Datatyp

boolean

Alias
UMLS CUI [1]
C0342579
27. subjects with any underlying cardiac disease
Beskrivning

Heart Disease Primary

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205225
28. subjects who have received qt-prolonging drugs or potent cytochrome p450 (cyp) 3a4 inhibitors within 4 weeks of screening
Beskrivning

Pharmaceutical Preparations Causing Prolonged QT interval | CYP3A4 Inhibitors Strong

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0678227
UMLS CUI [1,3]
C0151878
UMLS CUI [2,1]
C3850053
UMLS CUI [2,2]
C0442821
29. failure to satisfy the investigator of fitness to participate for any other reason
Beskrivning

Study Subject Participation Status Medically unfit

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C3841806
Tillbaka till toppen

Similar models

Eligibility Parkinson's Disease NCT02486432

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender Healthy | Pregnancy Absent | Breast Feeding Absent
Item
1. healthy males or non-pregnant, non-lactating healthy females
boolean
C0079399 (UMLS CUI [1,1])
C3898900 (UMLS CUI [1,2])
C0032961 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0006147 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Age
Item
2. age 40 to 65 years of age
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
3. body mass index of 18.0 to 35.0 kg/m2 or, if outside the range, considered not clinically significant by the investigator
boolean
C1305855 (UMLS CUI [1])
Communication Willing | Able to communicate | Participation Clinical Trial Willing | Participation Clinical Trial Able
Item
4. must be willing and able to communicate and participate in the whole study
boolean
C0009452 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
C2364293 (UMLS CUI [2])
C0679823 (UMLS CUI [3,1])
C0008976 (UMLS CUI [3,2])
C0600109 (UMLS CUI [3,3])
C0679823 (UMLS CUI [4,1])
C0008976 (UMLS CUI [4,2])
C0085732 (UMLS CUI [4,3])
Informed Consent
Item
5. must provide written informed consent
boolean
C0021430 (UMLS CUI [1])
Use of Contraceptive methods
Item
6. must agree to use an adequate method of contraception
boolean
C1524063 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status
Item
1. participation in a clinical research study within the previous 3 months
boolean
C2348568 (UMLS CUI [1])
Employee Study Site | Family member Study Site | Employee Sponsor
Item
2. subjects who are study site employees, or immediate family members of a study site or sponsor employee
boolean
C0599987 (UMLS CUI [1,1])
C2347790 (UMLS CUI [1,2])
C0086282 (UMLS CUI [2,1])
C2347790 (UMLS CUI [2,2])
C0599987 (UMLS CUI [3,1])
C2347796 (UMLS CUI [3,2])
Study Subject Participation Status | Enrollment Previous
Item
3. subjects who have previously been enrolled in this study
boolean
C2348568 (UMLS CUI [1])
C1516879 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
Substance Use Disorders
Item
4. history of any drug or alcohol abuse in the past 2 years
boolean
C0038586 (UMLS CUI [1])
Alcohol consumption Regular | Alcohol units/week Beer | Alcohol units/week Spirit | Alcohol units/week Wine | Gender
Item
5. regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = ½ pint beer, 25 ml of 40% spirit or a 125 ml glass of wine)
boolean
C0001948 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C0560579 (UMLS CUI [2,1])
C0004922 (UMLS CUI [2,2])
C0560579 (UMLS CUI [3,1])
C0301611 (UMLS CUI [3,2])
C0560579 (UMLS CUI [4,1])
C0043188 (UMLS CUI [4,2])
C0079399 (UMLS CUI [5])
Tobacco use | Breath test expired carbon monoxide
Item
6. current smokers and those who have smoked within the last 12 months. a breath carbon monoxide reading of greater than 10 ppm at screening
boolean
C0543414 (UMLS CUI [1])
C2207180 (UMLS CUI [2])
Pregnancy | Breast Feeding | Childbearing Potential Urine pregnancy test negative
Item
7. females of childbearing potential who are pregnant or lactating (female subjects must have a negative urine pregnancy test at admission)
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0430057 (UMLS CUI [3,2])
Abnormal biochemistry finding | Hematology finding abnormal | Urine screening abnormal
Item
8. clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator (laboratory parameters are listed in appendix 1)
boolean
C0586680 (UMLS CUI [1])
C0475182 (UMLS CUI [2])
C0438142 (UMLS CUI [3])
Drug abuse screening test Positive
Item
9. positive drugs of abuse test result (drugs of abuse tests are listed in appendix 1)
boolean
C0451130 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
Hepatitis B surface antigen positive | Hepatitis C antibody positive | HIV Seropositivity
Item
10. positive hepatitis b surface antigen (hbsag), hepatitis c virus antibody (hcv ab) or human immunodeficiency virus (hiv) results
boolean
C0149709 (UMLS CUI [1])
C0281863 (UMLS CUI [2])
C0019699 (UMLS CUI [3])
Cardiovascular Disease | Kidney Disease | Liver disease | Chronic disease of respiratory system | Gastrointestinal Disease
Item
11. history of cardiovascular, renal, hepatic, chronic respiratory or gi disease as judged by the investigator
boolean
C0007222 (UMLS CUI [1])
C0022658 (UMLS CUI [2])
C0023895 (UMLS CUI [3])
C0264220 (UMLS CUI [4])
C0017178 (UMLS CUI [5])
Adverse reaction Serious Pharmaceutical Preparations | Hypersensitivity Serious Pharmaceutical Preparations | Adverse reaction Serious Pharmaceutical Excipient | Hypersensitivity Serious Pharmaceutical Excipient
Item
12. serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
boolean
C0559546 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0013227 (UMLS CUI [2,3])
C0559546 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C0015237 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0205404 (UMLS CUI [4,2])
C0015237 (UMLS CUI [4,3])
Hypersensitivity Treatment required for
Item
13. presence or history of clinically significant allergy requiring treatment, as judged by the investigator. hayfever is allowed unless it is active
boolean
C0020517 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
Blood Donation Amount | Blood Loss Amount
Item
14. donation or loss of greater than 400 ml of blood within the previous 3 months
boolean
C0005794 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C3163616 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Prescription of drug | Drugs, Non-Prescription | Exception Acetaminophen U/day | Exception Hormone replacement therapy | Exception Hormonal contraception | Herbal medicine
Item
15. subjects who are taking, or have taken, any prescribed or over-the-counter drug (other than 4 g per day paracetamol, hormone replacement therapy and hormonal contraception) or herbal remedies in the 14 days before imp administration (see section 11.4)
boolean
C2239117 (UMLS CUI [1])
C0013231 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0000970 (UMLS CUI [3,2])
C0456683 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0282402 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C2985296 (UMLS CUI [5,2])
C2240391 (UMLS CUI [6])
Monoamine oxidase inhibitors, non-selective
Item
16. use of any non-selective monoamine oxidase (mao) inhibitors within 2 weeks of screening
boolean
C3653330 (UMLS CUI [1])
Glaucoma
Item
17. history or presence of glaucoma
boolean
C0017601 (UMLS CUI [1])
Skin lesion Suspicious | Melanoma
Item
18. history or presence of suspicious undiagnosed skin lesions or a history of melanoma
boolean
C0037284 (UMLS CUI [1,1])
C0750493 (UMLS CUI [1,2])
C0025202 (UMLS CUI [2])
Psychotic Disorders | Seizure
Item
19. any history of psychoses or seizure
boolean
C0033975 (UMLS CUI [1])
C0036572 (UMLS CUI [2])
Hypersensitivity Sinemet | Domperidone allergy | Hypersensitivity Sinemet Excipient | Hypersensitivity Domperidone Excipient
Item
20. known hypersensitivity to sinemet® or domperidone or any of the excipients
boolean
C0020517 (UMLS CUI [1,1])
C0074559 (UMLS CUI [1,2])
C0570598 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C0074559 (UMLS CUI [3,2])
C0015237 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0013015 (UMLS CUI [4,2])
C0015237 (UMLS CUI [4,3])
Prolactinoma
Item
21. any history or presence of prolactin-releasing pituitary tumour (prolactinoma)
boolean
C0033375 (UMLS CUI [1])
Gastrointestinal Hemorrhage | Gastrointestinal obstruction | Gastrointestinal perforation
Item
22. any medical history of gi haemorrhage, mechanical obstruction or perforation
boolean
C0017181 (UMLS CUI [1])
C0236124 (UMLS CUI [2])
C0151664 (UMLS CUI [3])
Hepatic impairment Moderate | Hepatic impairment Severe
Item
23. any history of moderate or severe hepatic impairment
boolean
C0948807 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0948807 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Liver Function Tests Clinical Significance
Item
24. subjects with clinically significant liver function tests
boolean
C0023901 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Prolonged QTc
Item
25. subjects with qtc > 450 ms at screening sponsor/quotient clinical confidential protocol nd0612-013 (qcl117546) version 1.0 02 feb 2015 page 23 of 42
boolean
C1969409 (UMLS CUI [1])
Electrolyte imbalance
Item
26. subjects with significant electrolyte disturbances
boolean
C0342579 (UMLS CUI [1])
Heart Disease Primary
Item
27. subjects with any underlying cardiac disease
boolean
C0018799 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
Pharmaceutical Preparations Causing Prolonged QT interval | CYP3A4 Inhibitors Strong
Item
28. subjects who have received qt-prolonging drugs or potent cytochrome p450 (cyp) 3a4 inhibitors within 4 weeks of screening
boolean
C0013227 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0151878 (UMLS CUI [1,3])
C3850053 (UMLS CUI [2,1])
C0442821 (UMLS CUI [2,2])
Study Subject Participation Status Medically unfit
Item
29. failure to satisfy the investigator of fitness to participate for any other reason
boolean
C2348568 (UMLS CUI [1,1])
C3841806 (UMLS CUI [1,2])
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