ID

39576

Description

Interaction Between Paroxetine and Telaprevir; ODM derived from: https://clinicaltrials.gov/show/NCT01841502

Link

https://clinicaltrials.gov/show/NCT01841502

Keywords

Versions (2)
  1. 1/30/20 1/30/20 -
  2. 1/31/20 1/31/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 31, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis C Infection NCT01841502

English

Eligibility Hepatitis C Infection NCT01841502

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subject is at least 18 and not older than 65 years at screening.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
subject is able and willing to sign the informed consent form prior to screening evaluations.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
subject has a chronic hcv infection with genotype 1.
Description

Chronic Hepatitis C Genotype

Data type

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C1148363
subject is eligible for telaprevir containing hcv treatment.
Description

Therapy HCV | Telaprevir

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0019196
UMLS CUI [2]
C1876229
subject is on a stable dose of 20 mg paroxetine once daily for at least 4 weeks.
Description

Paroxetine Dose Stable U/day

Data type

boolean

Alias
UMLS CUI [1,1]
C0070122
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [1,4]
C0456683
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
documented history of sensitivity/idiosyncrasy to medicinal products or excipients.
Description

Drug Allergy | Idiosyncrasy Pharmaceutical Preparations | Hypersensitivity Pharmaceutical Preparation Excipient | Idiosyncrasy Pharmaceutical Preparation Excipient

Data type

boolean

Alias
UMLS CUI [1]
C0013182
UMLS CUI [2,1]
C0231191
UMLS CUI [2,2]
C0013227
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0013227
UMLS CUI [3,3]
C0015237
UMLS CUI [4,1]
C0231191
UMLS CUI [4,2]
C0013227
UMLS CUI [4,3]
C0015237
pregnant female (as confirmed by a human chorionic gonadotropin (hcg) test performed less than 6 weeks before day -1) or breast-feeding female. female subjects of childbearing potential without adequate contraception, e.g. hysterectomy, bilateral tubal ligation, (non-hormonal) intrauterine device, total abstinence, double barrier methods, or two years post-menopausal. they must agree to take precautions in order to prevent a pregnancy throughout.
Description

Pregnancy HCG pregnancy test | Breast Feeding | Childbearing Potential Contraceptive methods Absent | Hysterectomy | Bilateral tubal ligation | Intrauterine Devices | Sexual Abstinence | Barrier Contraception Double | Postmenopausal state Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0546577
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0332197
UMLS CUI [4]
C0020699
UMLS CUI [5]
C0589114
UMLS CUI [6]
C0021900
UMLS CUI [7]
C0036899
UMLS CUI [8,1]
C0004764
UMLS CUI [8,2]
C0205173
UMLS CUI [9,1]
C0232970
UMLS CUI [9,2]
C0449238
relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
Description

Condition Interferes with Drug absorption | Condition Interferes with Drug distribution | Condition Interferes with Drug metabolism | Condition Interferes with Drug elimination

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0678745
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0699903
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0683140
UMLS CUI [4,1]
C0348080
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0683141
inability to understand the nature and extent of the trial and the procedures required.
Description

Study Protocol Comprehension Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0162340
UMLS CUI [1,3]
C1299582
participation in a drug trial within 60 days prior to the first dose of telaprevir.
Description

Study Subject Participation Status | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
use of relevant concomitant medication, as assessed by a hospital pharmacist (member of the study team).
Description

Pharmaceutical Preparation concomitant

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0521115
hemoglobin < 12 g/dl (females) or < 13 g/dl (males) (7.4 respectively 8.0 mm).
Description

Hemoglobin measurement | Gender

Data type

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C0079399
poor- or ultrarapid metabolizer cyp2d6 (based on genetic testing)
Description

CYP2D6 poor metaboliser status Genetic testing | CYP2D6 ultrarapid metaboliser status Genetic testing

Data type

boolean

Alias
UMLS CUI [1,1]
C3888904
UMLS CUI [1,2]
C0679560
UMLS CUI [2,1]
C3203681
UMLS CUI [2,2]
C0679560
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Similar models

Eligibility Hepatitis C Infection NCT01841502

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
subject is at least 18 and not older than 65 years at screening.
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
subject is able and willing to sign the informed consent form prior to screening evaluations.
boolean
C0021430 (UMLS CUI [1])
Chronic Hepatitis C Genotype
Item
subject has a chronic hcv infection with genotype 1.
boolean
C0524910 (UMLS CUI [1,1])
C1148363 (UMLS CUI [1,2])
Therapy HCV | Telaprevir
Item
subject is eligible for telaprevir containing hcv treatment.
boolean
C0087111 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])
C1876229 (UMLS CUI [2])
Paroxetine Dose Stable U/day
Item
subject is on a stable dose of 20 mg paroxetine once daily for at least 4 weeks.
boolean
C0070122 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0456683 (UMLS CUI [1,4])
Item Group
C0680251 (UMLS CUI)
Drug Allergy | Idiosyncrasy Pharmaceutical Preparations | Hypersensitivity Pharmaceutical Preparation Excipient | Idiosyncrasy Pharmaceutical Preparation Excipient
Item
documented history of sensitivity/idiosyncrasy to medicinal products or excipients.
boolean
C0013182 (UMLS CUI [1])
C0231191 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
C0015237 (UMLS CUI [3,3])
C0231191 (UMLS CUI [4,1])
C0013227 (UMLS CUI [4,2])
C0015237 (UMLS CUI [4,3])
Pregnancy HCG pregnancy test | Breast Feeding | Childbearing Potential Contraceptive methods Absent | Hysterectomy | Bilateral tubal ligation | Intrauterine Devices | Sexual Abstinence | Barrier Contraception Double | Postmenopausal state Duration
Item
pregnant female (as confirmed by a human chorionic gonadotropin (hcg) test performed less than 6 weeks before day -1) or breast-feeding female. female subjects of childbearing potential without adequate contraception, e.g. hysterectomy, bilateral tubal ligation, (non-hormonal) intrauterine device, total abstinence, double barrier methods, or two years post-menopausal. they must agree to take precautions in order to prevent a pregnancy throughout.
boolean
C0032961 (UMLS CUI [1,1])
C0546577 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C0020699 (UMLS CUI [4])
C0589114 (UMLS CUI [5])
C0021900 (UMLS CUI [6])
C0036899 (UMLS CUI [7])
C0004764 (UMLS CUI [8,1])
C0205173 (UMLS CUI [8,2])
C0232970 (UMLS CUI [9,1])
C0449238 (UMLS CUI [9,2])
Condition Interferes with Drug absorption | Condition Interferes with Drug distribution | Condition Interferes with Drug metabolism | Condition Interferes with Drug elimination
Item
relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
boolean
C0348080 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0678745 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0699903 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0683140 (UMLS CUI [3,3])
C0348080 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0683141 (UMLS CUI [4,3])
Study Protocol Comprehension Unable
Item
inability to understand the nature and extent of the trial and the procedures required.
boolean
C2348563 (UMLS CUI [1,1])
C0162340 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Study Subject Participation Status | Investigational New Drugs
Item
participation in a drug trial within 60 days prior to the first dose of telaprevir.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Pharmaceutical Preparation concomitant
Item
use of relevant concomitant medication, as assessed by a hospital pharmacist (member of the study team).
boolean
C0013227 (UMLS CUI [1,1])
C0521115 (UMLS CUI [1,2])
Hemoglobin measurement | Gender
Item
hemoglobin < 12 g/dl (females) or < 13 g/dl (males) (7.4 respectively 8.0 mm).
boolean
C0518015 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
CYP2D6 poor metaboliser status Genetic testing | CYP2D6 ultrarapid metaboliser status Genetic testing
Item
poor- or ultrarapid metabolizer cyp2d6 (based on genetic testing)
boolean
C3888904 (UMLS CUI [1,1])
C0679560 (UMLS CUI [1,2])
C3203681 (UMLS CUI [2,1])
C0679560 (UMLS CUI [2,2])
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