ID

22276

Beschreibung

Study To Determine The Effects Of Doses Of Relacatib On The Metabolism Of Acetaminophen, Ibuprofen And Atorvastatin; ODM derived from: https://clinicaltrials.gov/show/NCT00411190

Link

https://clinicaltrials.gov/show/NCT00411190

Stichworte

Versionen (1)
  1. 28.05.17 28.05.17 -
Hochgeladen am

28. Mai 2017

DOI

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Creative Commons BY 4.0
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Eligibility Osteoporosis NCT00411190

Englisch

Eligibility Osteoporosis NCT00411190

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
healthy
Beschreibung

Healthy

Datentyp

boolean

Alias
UMLS CUI [1]
C3898900
postmenopausal
Beschreibung

Postmenopausal state

Datentyp

boolean

Alias
UMLS CUI [1]
C0232970
body weight > 50 kg
Beschreibung

Body Weight

Datentyp

boolean

Alias
UMLS CUI [1]
C0005910
body mass index (bmi) between 19 and 30
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
the subject is willing and able to give a signed and dated written informed consent prior to admission to the study
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
the subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.
Beschreibung

Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects with known morphea or sclerodermia
Beschreibung

Morphea | Scleroderma

Datentyp

boolean

Alias
UMLS CUI [1]
C1527383
UMLS CUI [2]
C0011644
subjects with a history of myocardial infarction.
Beschreibung

Myocardial Infarction

Datentyp

boolean

Alias
UMLS CUI [1]
C0027051
subjects with a history of renal/or hepatic disease unless the disease has been successfully treated and is no longer active; subjects with any evidence of renal/ or hepatic impairment on the screening physical and laboratory examination.
Beschreibung

Kidney Disease | Liver disease | Renal Insufficiency Physical Examination | Hepatic impairment Physical Examination | Renal Insufficiency Laboratory Procedures | Hepatic impairment Laboratory Procedures

Datentyp

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C0023895
UMLS CUI [3,1]
C1565489
UMLS CUI [3,2]
C0031809
UMLS CUI [4,1]
C0948807
UMLS CUI [4,2]
C0031809
UMLS CUI [5,1]
C1565489
UMLS CUI [5,2]
C0022885
UMLS CUI [6,1]
C0948807
UMLS CUI [6,2]
C0022885
subjects with history of hypertension or systolic blood pressure
Beschreibung

Hypertensive disease | Systolic Pressure

Datentyp

boolean

Alias
UMLS CUI [1]
C0020538
UMLS CUI [2]
C0871470
subjects with history of diabetes
Beschreibung

Diabetes Mellitus

Datentyp

boolean

Alias
UMLS CUI [1]
C0011849
history of regular alcohol consumption exceeding 7 drinks/week (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months of screening.
Beschreibung

Alcohol consumption Regular | Wine intake Quantity Weekly | Beer intake Quantity Weekly | Hard liquor intake Quantity Weekly

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0205272
UMLS CUI [2,1]
C0559432
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0332174
UMLS CUI [3,1]
C0559430
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0332174
UMLS CUI [4,1]
C0559433
UMLS CUI [4,2]
C1265611
UMLS CUI [4,3]
C0332174
history of use of tobacco- or nicotine-containing products within 6 months of screening, or a positive urine cotinine indicative of smoking at screening.
Beschreibung

Tobacco use | Product Containing Nicotine | Urine cotinine test positive

Datentyp

boolean

Alias
UMLS CUI [1]
C0543414
UMLS CUI [2,1]
C1514468
UMLS CUI [2,2]
C0332256
UMLS CUI [2,3]
C0028040
UMLS CUI [3]
C1699505
positive urine drug screen including alcohol (or alcohol breath test) at screening.
Beschreibung

Urine drug screen positive | Urine alcohol test positive | Breath alcohol test positive

Datentyp

boolean

Alias
UMLS CUI [1]
C0743300
UMLS CUI [2]
C1112219
UMLS CUI [3]
C1112499
positive for hiv, hepatitis b virus or hepatitis c virus.
Beschreibung

HIV Seropositivity | Hepatitis B virus test positive | Hepatitis C virus test positive

Datentyp

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C2748184
UMLS CUI [3]
C2748185
donation of blood in excess of 500 ml within 56 days prior to dosing
Beschreibung

Blood Donation Excess Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005794
UMLS CUI [1,2]
C1979886
UMLS CUI [1,3]
C1265611
history of sensitivity or contraindications to any of the study medications (i.e., relacatib, paracetamol, ibuprofen or atorvastatin) or components thereof.
Beschreibung

Hypersensitivity Investigational New Drugs | Medical contraindication Investigational New Drugs | Hypersensitivity Investigational New Drugs Component | Medical contraindication Investigational New Drugs Component | relacatib | Acetaminophen | Ibuprofen | atorvastatin

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0013230
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0013230
UMLS CUI [3,3]
C1705248
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C0013230
UMLS CUI [4,3]
C1705248
UMLS CUI [5]
C1700101
UMLS CUI [6]
C0000970
UMLS CUI [7]
C0020740
UMLS CUI [8]
C0286651
treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication.
Beschreibung

Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
subjects whom are judged by the investigator to be at risk for acute angle closure glaucoma.
Beschreibung

Study Subject At risk Angle Closure Glaucoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C0017605
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Ähnliche Modelle

Eligibility Osteoporosis NCT00411190

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Healthy
Item
healthy
boolean
C3898900 (UMLS CUI [1])
Postmenopausal state
Item
postmenopausal
boolean
C0232970 (UMLS CUI [1])
Body Weight
Item
body weight > 50 kg
boolean
C0005910 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) between 19 and 30
boolean
C1305855 (UMLS CUI [1])
Informed Consent
Item
the subject is willing and able to give a signed and dated written informed consent prior to admission to the study
boolean
C0021430 (UMLS CUI [1])
Protocol Compliance
Item
the subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Morphea | Scleroderma
Item
subjects with known morphea or sclerodermia
boolean
C1527383 (UMLS CUI [1])
C0011644 (UMLS CUI [2])
Myocardial Infarction
Item
subjects with a history of myocardial infarction.
boolean
C0027051 (UMLS CUI [1])
Kidney Disease | Liver disease | Renal Insufficiency Physical Examination | Hepatic impairment Physical Examination | Renal Insufficiency Laboratory Procedures | Hepatic impairment Laboratory Procedures
Item
subjects with a history of renal/or hepatic disease unless the disease has been successfully treated and is no longer active; subjects with any evidence of renal/ or hepatic impairment on the screening physical and laboratory examination.
boolean
C0022658 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C1565489 (UMLS CUI [3,1])
C0031809 (UMLS CUI [3,2])
C0948807 (UMLS CUI [4,1])
C0031809 (UMLS CUI [4,2])
C1565489 (UMLS CUI [5,1])
C0022885 (UMLS CUI [5,2])
C0948807 (UMLS CUI [6,1])
C0022885 (UMLS CUI [6,2])
Hypertensive disease | Systolic Pressure
Item
subjects with history of hypertension or systolic blood pressure
boolean
C0020538 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
Diabetes Mellitus
Item
subjects with history of diabetes
boolean
C0011849 (UMLS CUI [1])
Alcohol consumption Regular | Wine intake Quantity Weekly | Beer intake Quantity Weekly | Hard liquor intake Quantity Weekly
Item
history of regular alcohol consumption exceeding 7 drinks/week (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months of screening.
boolean
C0001948 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C0559432 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0332174 (UMLS CUI [2,3])
C0559430 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0332174 (UMLS CUI [3,3])
C0559433 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C0332174 (UMLS CUI [4,3])
Tobacco use | Product Containing Nicotine | Urine cotinine test positive
Item
history of use of tobacco- or nicotine-containing products within 6 months of screening, or a positive urine cotinine indicative of smoking at screening.
boolean
C0543414 (UMLS CUI [1])
C1514468 (UMLS CUI [2,1])
C0332256 (UMLS CUI [2,2])
C0028040 (UMLS CUI [2,3])
C1699505 (UMLS CUI [3])
Urine drug screen positive | Urine alcohol test positive | Breath alcohol test positive
Item
positive urine drug screen including alcohol (or alcohol breath test) at screening.
boolean
C0743300 (UMLS CUI [1])
C1112219 (UMLS CUI [2])
C1112499 (UMLS CUI [3])
HIV Seropositivity | Hepatitis B virus test positive | Hepatitis C virus test positive
Item
positive for hiv, hepatitis b virus or hepatitis c virus.
boolean
C0019699 (UMLS CUI [1])
C2748184 (UMLS CUI [2])
C2748185 (UMLS CUI [3])
Blood Donation Excess Quantity
Item
donation of blood in excess of 500 ml within 56 days prior to dosing
boolean
C0005794 (UMLS CUI [1,1])
C1979886 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Hypersensitivity Investigational New Drugs | Medical contraindication Investigational New Drugs | Hypersensitivity Investigational New Drugs Component | Medical contraindication Investigational New Drugs Component | relacatib | Acetaminophen | Ibuprofen | atorvastatin
Item
history of sensitivity or contraindications to any of the study medications (i.e., relacatib, paracetamol, ibuprofen or atorvastatin) or components thereof.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0013230 (UMLS CUI [3,2])
C1705248 (UMLS CUI [3,3])
C1301624 (UMLS CUI [4,1])
C0013230 (UMLS CUI [4,2])
C1705248 (UMLS CUI [4,3])
C1700101 (UMLS CUI [5])
C0000970 (UMLS CUI [6])
C0020740 (UMLS CUI [7])
C0286651 (UMLS CUI [8])
Investigational New Drugs
Item
treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication.
boolean
C0013230 (UMLS CUI [1])
Study Subject At risk Angle Closure Glaucoma
Item
subjects whom are judged by the investigator to be at risk for acute angle closure glaucoma.
boolean
C0681850 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0017605 (UMLS CUI [1,3])
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