ID

39575

Descrizione

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

collegamento

https://clinicaltrials.gov/show/NCT01841502

Keywords

versioni (2)
  1. 30/01/20 30/01/20 -
  2. 31/01/20 31/01/20 -
Titolare del copyright

See clinicaltrials.gov

Caricato su

30 gennaio 2020

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY-NC 3.0
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Eligibility Hepatitis C Infection NCT01841502

Inglese

Eligibility Hepatitis C Infection NCT01841502

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

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

Age

Tipo di dati

boolean

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

Informed Consent

Tipo di dati

boolean

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

Chronic Hepatitis C Genotype

Tipo di dati

boolean

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

HCV Therapy Containing Telaprevir

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0332256
UMLS CUI [1,4]
C1876229
subject is on a stable dose of 20 mg paroxetine once daily for at least 4 weeks.
Descrizione

Paroxetine Dose Stable U/day

Tipo di dati

boolean

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

Exclusion Criteria

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

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

Tipo di dati

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.
Descrizione

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

Tipo di dati

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.
Descrizione

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

Tipo di dati

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.
Descrizione

Study Protocol Comprehension Unable

Tipo di dati

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.
Descrizione

Study Subject Participation Status | Investigational New Drugs

Tipo di dati

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).
Descrizione

Pharmaceutical Preparation concomitant

Tipo di dati

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).
Descrizione

Hemoglobin measurement | Gender

Tipo di dati

boolean

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

CYP2D6 poor metaboliser status | CYP2D6 ultrarapid metaboliser status

Tipo di dati

boolean

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

Eligibility Hepatitis C Infection NCT01841502

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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])
HCV Therapy Containing Telaprevir
Item
subject is eligible for telaprevir containing hcv treatment.
boolean
C0019196 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0332256 (UMLS CUI [1,3])
C1876229 (UMLS CUI [1,4])
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 | CYP2D6 ultrarapid metaboliser status
Item
poor- or ultrarapid metabolizer cyp2d6 (based on genetic testing)
boolean
C3888904 (UMLS CUI [1])
C3203681 (UMLS CUI [2])
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