ID

31301

Beskrivning

A Study To Assess The Ability Of Tramadol, Naproxen And Oxycodone To Affect The Pain Thresholds Of Patients With Osteoarthritis Of The Thumb; ODM derived from: https://clinicaltrials.gov/show/NCT00743587

Länk

https://clinicaltrials.gov/show/NCT00743587

Nyckelord

Versioner (1)
  1. 2018-08-11 2018-08-11 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

11 augusti 2018

DOI

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Creative Commons BY 4.0
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Eligibility Osteoarthritis Thumbs NCT00743587

Engelsk

Eligibility Osteoarthritis Thumbs NCT00743587

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
the clinical diagnosis of osteoarthritis of the hand, of at least 6 months duration.
Beskrivning

Osteoarthritis of the hand Duration

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0263746
UMLS CUI [1,2]
C0449238
pain around one of the thumb joints due to osteoarthritis. the patient must report the average pain in this joint, in the week prior to screening, as at least 5 on an 11-point numerical pain rating scale at the time of screening.
Beskrivning

Pain Thumb joint Due to Osteoarthritis | Joint Pain Average Numeric Pain Scale

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0459473
UMLS CUI [1,3]
C0678226
UMLS CUI [1,4]
C0029408
UMLS CUI [2,1]
C4085641
UMLS CUI [2,2]
C1510992
UMLS CUI [2,3]
C1518471
the patient must demonstrate pressure pain at a thumb joint by reporting a pressure pain threshold lower than 300 kpa.
Beskrivning

Pain pressure Thumb joint | Pain pressure Threshold

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3647129
UMLS CUI [1,2]
C0459473
UMLS CUI [2,1]
C3647129
UMLS CUI [2,2]
C0449864
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant (as judged by a urine pregnancy test) or lactating female.
Beskrivning

Pregnancy Urine pregnancy test | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0430056
UMLS CUI [2]
C0006147
other severe pain which may impair the assessment of the pain due to osteoarthritis.
Beskrivning

Severe pain | Assessment Limited Osteoarthritis Pain

Datatyp

boolean

Alias
UMLS CUI [1]
C0278140
UMLS CUI [2,1]
C1516048
UMLS CUI [2,2]
C0439801
UMLS CUI [2,3]
C0029408
UMLS CUI [2,4]
C0030193
skin condition over the thumb joint, which will be used for pain threshold testing, that could interfere with the assessment of pain thresholds.
Beskrivning

Dermatologic disorder Thumb joint | Pain Threshold Testing | Interference Assessment Pain Threshold

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0037274
UMLS CUI [1,2]
C0459473
UMLS CUI [2,1]
C0162703
UMLS CUI [2,2]
C0039593
UMLS CUI [3,1]
C0521102
UMLS CUI [3,2]
C1516048
UMLS CUI [3,3]
C0162703
known hypersensitivity to oxycodone, nsaids or tramadol.
Beskrivning

OXYCODONE ALLERGY | Allergy to nonsteroidal anti-inflammatory agents | Allergy to tramadol

Datatyp

boolean

Alias
UMLS CUI [1]
C0747116
UMLS CUI [2]
C0746949
UMLS CUI [3]
C3472517
patients in whom nsaids, oxycodone or tramadol are contraindicated, or patients taking any concurrent medications which are contraindicated with any of the study medications .
Beskrivning

Medical contraindication NSAIDs | Medical contraindication Oxycodone | Medical contraindication Tramadol | Pharmaceutical Preparations Contraindicated Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0003211
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0030049
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0040610
UMLS CUI [4,1]
C0013227
UMLS CUI [4,2]
C1444657
UMLS CUI [4,3]
C0013230
an estimated renal clearance of less than 30 ml/min based on the cockcroft gault equation.
Beskrivning

Renal clearance Predicted by Cockcroft-Gault formula

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0232813
UMLS CUI [1,2]
C4544894
use of prohibited medications as listed below, in the absence of appropriate washout periods:
Beskrivning

Illicit medication use | Washout Period Appropriate Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C0281875
UMLS CUI [2,1]
C1710661
UMLS CUI [2,2]
C1548787
UMLS CUI [2,3]
C0332197
oral or intramuscular corticosteroids within 4 weeks prior to screening.
Beskrivning

Adrenal Cortex Hormones Oral | Adrenal Cortex Hormones Intramuscular

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C1527415
UMLS CUI [2,1]
C0001617
UMLS CUI [2,2]
C1556154
monoamine oxidase inhibitors within 2 weeks of screening.
Beskrivning

Monoamine Oxidase Inhibitors

Datatyp

boolean

Alias
UMLS CUI [1]
C0026457
analgesic agents, other than aspirin, or acetaminophen within 1 week prior to screening. (aspirin use less than or equal to 325 mg per day for cardiovascular prophylaxis is permitted)
Beskrivning

Analgesics | Exception Aspirin | Exception Acetaminophen | Aspirin Cardiovascular event prophylaxis allowed

Datatyp

boolean

Alias
UMLS CUI [1]
C0002771
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0004057
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0000970
UMLS CUI [4,1]
C0004057
UMLS CUI [4,2]
C1610618
UMLS CUI [4,3]
C0683607
acetaminophen up to 4 g/day may be used, provided it is not used in the 24 hours prior to any assessment of pain thresholds.
Beskrivning

Acetaminophen U/day allowed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0000970
UMLS CUI [1,2]
C0456683
UMLS CUI [1,3]
C0683607
intra-articular steroid injections into the study joint within 12 weeks, or to any other joint within 4 weeks, prior to screening.
Beskrivning

Intraarticular injection of steroids Index Joint | Intraarticular injection of steroids Joint

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2064783
UMLS CUI [1,2]
C2986546
UMLS CUI [1,3]
C0022417
UMLS CUI [2,1]
C2064783
UMLS CUI [2,2]
C0022417
history of chronic constipation, or of any condition which, in the opinion of the investigator, may put the patient at increased risk of respiratory depression.
Beskrivning

Chronic constipation | Condition At risk Respiratory Depression

Datatyp

boolean

Alias
UMLS CUI [1]
C0401149
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C0235063
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Similar models

Eligibility Osteoarthritis Thumbs NCT00743587

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Osteoarthritis of the hand Duration
Item
the clinical diagnosis of osteoarthritis of the hand, of at least 6 months duration.
boolean
C0263746 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Pain Thumb joint Due to Osteoarthritis | Joint Pain Average Numeric Pain Scale
Item
pain around one of the thumb joints due to osteoarthritis. the patient must report the average pain in this joint, in the week prior to screening, as at least 5 on an 11-point numerical pain rating scale at the time of screening.
boolean
C0030193 (UMLS CUI [1,1])
C0459473 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0029408 (UMLS CUI [1,4])
C4085641 (UMLS CUI [2,1])
C1510992 (UMLS CUI [2,2])
C1518471 (UMLS CUI [2,3])
Pain pressure Thumb joint | Pain pressure Threshold
Item
the patient must demonstrate pressure pain at a thumb joint by reporting a pressure pain threshold lower than 300 kpa.
boolean
C3647129 (UMLS CUI [1,1])
C0459473 (UMLS CUI [1,2])
C3647129 (UMLS CUI [2,1])
C0449864 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy Urine pregnancy test | Breast Feeding
Item
pregnant (as judged by a urine pregnancy test) or lactating female.
boolean
C0032961 (UMLS CUI [1,1])
C0430056 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2])
Severe pain | Assessment Limited Osteoarthritis Pain
Item
other severe pain which may impair the assessment of the pain due to osteoarthritis.
boolean
C0278140 (UMLS CUI [1])
C1516048 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C0029408 (UMLS CUI [2,3])
C0030193 (UMLS CUI [2,4])
Dermatologic disorder Thumb joint | Pain Threshold Testing | Interference Assessment Pain Threshold
Item
skin condition over the thumb joint, which will be used for pain threshold testing, that could interfere with the assessment of pain thresholds.
boolean
C0037274 (UMLS CUI [1,1])
C0459473 (UMLS CUI [1,2])
C0162703 (UMLS CUI [2,1])
C0039593 (UMLS CUI [2,2])
C0521102 (UMLS CUI [3,1])
C1516048 (UMLS CUI [3,2])
C0162703 (UMLS CUI [3,3])
OXYCODONE ALLERGY | Allergy to nonsteroidal anti-inflammatory agents | Allergy to tramadol
Item
known hypersensitivity to oxycodone, nsaids or tramadol.
boolean
C0747116 (UMLS CUI [1])
C0746949 (UMLS CUI [2])
C3472517 (UMLS CUI [3])
Medical contraindication NSAIDs | Medical contraindication Oxycodone | Medical contraindication Tramadol | Pharmaceutical Preparations Contraindicated Investigational New Drugs
Item
patients in whom nsaids, oxycodone or tramadol are contraindicated, or patients taking any concurrent medications which are contraindicated with any of the study medications .
boolean
C1301624 (UMLS CUI [1,1])
C0003211 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0030049 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C0040610 (UMLS CUI [3,2])
C0013227 (UMLS CUI [4,1])
C1444657 (UMLS CUI [4,2])
C0013230 (UMLS CUI [4,3])
Renal clearance Predicted by Cockcroft-Gault formula
Item
an estimated renal clearance of less than 30 ml/min based on the cockcroft gault equation.
boolean
C0232813 (UMLS CUI [1,1])
C4544894 (UMLS CUI [1,2])
Illicit medication use | Washout Period Appropriate Absent
Item
use of prohibited medications as listed below, in the absence of appropriate washout periods:
boolean
C0281875 (UMLS CUI [1])
C1710661 (UMLS CUI [2,1])
C1548787 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Adrenal Cortex Hormones Oral | Adrenal Cortex Hormones Intramuscular
Item
oral or intramuscular corticosteroids within 4 weeks prior to screening.
boolean
C0001617 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0001617 (UMLS CUI [2,1])
C1556154 (UMLS CUI [2,2])
Monoamine Oxidase Inhibitors
Item
monoamine oxidase inhibitors within 2 weeks of screening.
boolean
C0026457 (UMLS CUI [1])
Analgesics | Exception Aspirin | Exception Acetaminophen | Aspirin Cardiovascular event prophylaxis allowed
Item
analgesic agents, other than aspirin, or acetaminophen within 1 week prior to screening. (aspirin use less than or equal to 325 mg per day for cardiovascular prophylaxis is permitted)
boolean
C0002771 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0004057 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0000970 (UMLS CUI [3,2])
C0004057 (UMLS CUI [4,1])
C1610618 (UMLS CUI [4,2])
C0683607 (UMLS CUI [4,3])
Acetaminophen U/day allowed
Item
acetaminophen up to 4 g/day may be used, provided it is not used in the 24 hours prior to any assessment of pain thresholds.
boolean
C0000970 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
C0683607 (UMLS CUI [1,3])
Intraarticular injection of steroids Index Joint | Intraarticular injection of steroids Joint
Item
intra-articular steroid injections into the study joint within 12 weeks, or to any other joint within 4 weeks, prior to screening.
boolean
C2064783 (UMLS CUI [1,1])
C2986546 (UMLS CUI [1,2])
C0022417 (UMLS CUI [1,3])
C2064783 (UMLS CUI [2,1])
C0022417 (UMLS CUI [2,2])
Chronic constipation | Condition At risk Respiratory Depression
Item
history of chronic constipation, or of any condition which, in the opinion of the investigator, may put the patient at increased risk of respiratory depression.
boolean
C0401149 (UMLS CUI [1])
C0348080 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C0235063 (UMLS CUI [2,3])
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